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BOSTON--(BUSINESS WIRE)--Today, FDNA (www.FDNA.com) announces its collaboration with two of the most reputable genomics testing labs in the world, GeneDx and Blueprint Genetics. The collaboration will fully integrate FDNA’s analysis into the genetic testing workflow of these labs by enabling clinicians to share phenotypic data with these labs in real time. This marks the first time clinicians will have the ability to send phenotypic data, including facial analysis collected through FDNA’s Face2Gene suite, directly to labs, paving the way for a new precision medicine industry standard. Founded in 2011, FDNA is committed to helping clinicians, labs and researchers diagnose, treat and create therapies for rare diseases. FDNA’s Face2Gene suite of applications helps to quickly evaluate patients’ clinical signs through artificial intelligence and facial analysis. With a comprehensive database of more than 10,000 rare disease syndromes, this new LABS capability is improving the speed and accuracy of a diagnosis for rare disease patients. “Trying to diagnose patients with genetic sequencing is like searching for a pin in a 22,000-needle haystack,” said Dekel Gelbman, CEO of FDNA. “By providing accurate phenotypic and clinical data to the lab directly at the point of genetic interpretation, we are truly realizing the promise of precision medicine. And, with the power of artificial intelligence behind it, clinicians will be pointed toward potential diagnoses that they may have never otherwise considered. GeneDx and Blueprint Genetics are both examples of innovative and renowned labs adopting technology that will lead the way in pinpointing rare disease and promote further medical advancements.” The results of PEDIA, a recent study led by the Berlin Institute of health and Charité University of Medicine, displayed exciting results of this collaboration on the accuracy of genetic sequencing. “We estimate that the addition of phenotypic features [encoded in HPO terms] increases the diagnostic yield to about 60% [from 25% without]. When adding facial analysis, FDNA’s technology, to that process, the diagnostic yield increases to more than 85%,” explained Dr. Peter Krawitz, Principal Investigator of PEDIA. One in 10 people worldwide suffer from a rare genetic disease, and often the search for answers is a tiresome journey. With hundreds of millions of patients having their phenotypic information buried in paper files and unstructured data, it is challenging to integrate this information to support the variant interpretation process. With the Face2Gene LABS application, all of this information is available immediately to support the analysis of genetic testing to help clinicians pinpoint the disease-causing genetic variants as they draw clearer and more efficient conclusions. “This is an important collaboration for several reasons,” said Dr. Ben Solomon, Managing Director of GeneDx and practicing clinical geneticist. “It’s a great way to leverage clinical and genetic information and machine learning approaches to find answers for the clinicians, patients and families GeneDx serves. Aside from providing answers, this integration will make the diagnostic testing process easier, smoother and more enjoyable for clinicians.” “Since 2012, Blueprint Genetics has been developing technological innovations in sequencing and clinical interpretation to improve the quality and performance of rare disease diagnostics,” said Dr. Tero-Pekka Alastalo, PhD and Chief Medical Officer of Blueprint Genetics. “It’s great to see how these innovations are now helping the genetics community and patients suffering from inherited disorders. Combining these technological innovations with our transparent approach to diagnostics and next generation phenotyping tools like Face2Gene represents the next steps forward in molecular genetic diagnostics.” About FDNA and Face2Gene FDNA is the developer of Face2Gene, a clinical suite of phenotyping applications that facilitates comprehensive and precise genetic evaluations. Face2Gene uses facial analysis, deep learning and artificial intelligence to transform big data into actionable genomic insights to improve and accelerate diagnostics and therapeutics. With the world’s largest network of clinicians, labs and researchers creating one of the fastest growing and most comprehensive genomic databases, FDNA is changing the lives of rare disease patients. For more information, visit www.FDNA.com. About GeneDx GeneDx is a world leader in genomics with an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx provides testing to patients and their families in more than 55 countries. GeneDx is a wholly-owned subsidiary of BioReference Laboratories, an OPKO Health, Inc. company. For more information, visit www.genedx.com. About Blueprint Genetics Blueprint Genetics is a genetic diagnostic laboratory that provides comprehensive genetics testing services through innovative technologies. This includes DNA sequencing and clinical interpretation in human rare diseases that enable improved quality and performance, faster lead-time and overall cost efficiency. With IBM Watson-powered CLINT technology, Blueprint Genetics’ expert team of geneticists and clinicians provide top-quality clinical interpretation and reporting, changing the standards of molecular diagnostics. For more information, visit www.blueprintgenetics.com.


MIAMI, June 07, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK) announced today that GeneDx, a business unit of OPKO’s BioReference Laboratories division, extended its relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services. UC Health, one of the nation’s leaders in genomics and precision medicine in both the clinical and investigational arenas, has selected GeneDx to supplement UC Health’s own robust offering of genetic, genomic, and molecular testing services.  By  having access to the latest in next generation genetics and molecular oncology resources, both internally and externally, UC Health remains at the forefront of precision medicine.  OPKO’s GeneDx is a leading commercial genetics laboratory in the United States, while OPKO’s GenPath Oncology division was among the first in the nation to focus on the molecular understanding of cancer. “The foundation of precision medicine is precision diagnostics, and through this relationship with OPKO’s GeneDx, our customers at UC Health will not just better understand disease, but will close the gap between data and diagnosis to help ensure good outcomes for individuals and their communities,” said Gregory S. Henderson, MD, PhD, President of BioReference Laboratories.  “UC Health already provides some of the best thinking in the country on the use of diagnostic tools in clinical genomics and precision medicine.  Whole Exome Sequencing and other clinical services offered by GeneDx will give UC Health’s world class doctors, genetic counselors and other clinicians actionable insight into some of the most pressing health challenges faced by their patients and could expand the potential for their research to produce good outcomes.” GeneDx offers UC Health unique tools for understanding cancer, rare diseases, prenatal conditions, and some of the most difficult problems in medical diagnosis through a comprehensive menu of genetic and genomic tests that will supplement UC Health’s testing infrastructure across its medical centers at the UC Health campuses. An important differentiator is GeneDx’s advanced analytic tools, which not only provide the highest level of genetic testing, but also the technology to add insight to the findings. GeneDx has developed a unique,  clinician focused population health tool that allows end users to better manage and track their data at a cohort or individual level in a protected and compliant manner. About the University of California Founded in 1868, the University of California is a public university system that is considered the most comprehensive and advanced postsecondary educational system in the world.  UC comprises ten college campuses and five medical centers with more than 238,000 students.  For more information, visit https://www.universityofcalifornia.edu/uc-system. About GeneDx GeneDx is a world leader in genomics with an acknowledged expertise in rare and ultra rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. Providing testing to patients and their families in more than 55 countries, GeneDx is a business unit of BioReference Laboratories, a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com. About OPKO Health, Inc.  OPKO Health is a diversified healthcare company that seeks to establish industry leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy), OPK88002, a NK-1 antagonist to treat pruritus ( itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet syndrome. In addition, the Company is advancing its CTP technology, which includes long acting hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and long acting Factor VIIa drug for hemophilia in phase 2a.  OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the expected expansion of our relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services, expected benefits from the relationship and the ability to close the gap between data and diagnosis to help ensure good outcomes for individuals, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


MIAMI, June 07, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK) announced today that GeneDx, a business unit of OPKO’s BioReference Laboratories division, extended its relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services. UC Health, one of the nation’s leaders in genomics and precision medicine in both the clinical and investigational arenas, has selected GeneDx to supplement UC Health’s own robust offering of genetic, genomic, and molecular testing services.  By  having access to the latest in next generation genetics and molecular oncology resources, both internally and externally, UC Health remains at the forefront of precision medicine.  OPKO’s GeneDx is a leading commercial genetics laboratory in the United States, while OPKO’s GenPath Oncology division was among the first in the nation to focus on the molecular understanding of cancer. “The foundation of precision medicine is precision diagnostics, and through this relationship with OPKO’s GeneDx, our customers at UC Health will not just better understand disease, but will close the gap between data and diagnosis to help ensure good outcomes for individuals and their communities,” said Gregory S. Henderson, MD, PhD, President of BioReference Laboratories.  “UC Health already provides some of the best thinking in the country on the use of diagnostic tools in clinical genomics and precision medicine.  Whole Exome Sequencing and other clinical services offered by GeneDx will give UC Health’s world class doctors, genetic counselors and other clinicians actionable insight into some of the most pressing health challenges faced by their patients and could expand the potential for their research to produce good outcomes.” GeneDx offers UC Health unique tools for understanding cancer, rare diseases, prenatal conditions, and some of the most difficult problems in medical diagnosis through a comprehensive menu of genetic and genomic tests that will supplement UC Health’s testing infrastructure across its medical centers at the UC Health campuses. An important differentiator is GeneDx’s advanced analytic tools, which not only provide the highest level of genetic testing, but also the technology to add insight to the findings. GeneDx has developed a unique,  clinician focused population health tool that allows end users to better manage and track their data at a cohort or individual level in a protected and compliant manner. About the University of California Founded in 1868, the University of California is a public university system that is considered the most comprehensive and advanced postsecondary educational system in the world.  UC comprises ten college campuses and five medical centers with more than 238,000 students.  For more information, visit https://www.universityofcalifornia.edu/uc-system. About GeneDx GeneDx is a world leader in genomics with an acknowledged expertise in rare and ultra rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. Providing testing to patients and their families in more than 55 countries, GeneDx is a business unit of BioReference Laboratories, a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com. About OPKO Health, Inc.  OPKO Health is a diversified healthcare company that seeks to establish industry leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy), OPK88002, a NK-1 antagonist to treat pruritus ( itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet syndrome. In addition, the Company is advancing its CTP technology, which includes long acting hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and long acting Factor VIIa drug for hemophilia in phase 2a.  OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the expected expansion of our relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services, expected benefits from the relationship and the ability to close the gap between data and diagnosis to help ensure good outcomes for individuals, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


MIAMI, June 07, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK) announced today that GeneDx, a business unit of OPKO’s BioReference Laboratories division, extended its relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services. UC Health, one of the nation’s leaders in genomics and precision medicine in both the clinical and investigational arenas, has selected GeneDx to supplement UC Health’s own robust offering of genetic, genomic, and molecular testing services.  By  having access to the latest in next generation genetics and molecular oncology resources, both internally and externally, UC Health remains at the forefront of precision medicine.  OPKO’s GeneDx is a leading commercial genetics laboratory in the United States, while OPKO’s GenPath Oncology division was among the first in the nation to focus on the molecular understanding of cancer. “The foundation of precision medicine is precision diagnostics, and through this relationship with OPKO’s GeneDx, our customers at UC Health will not just better understand disease, but will close the gap between data and diagnosis to help ensure good outcomes for individuals and their communities,” said Gregory S. Henderson, MD, PhD, President of BioReference Laboratories.  “UC Health already provides some of the best thinking in the country on the use of diagnostic tools in clinical genomics and precision medicine.  Whole Exome Sequencing and other clinical services offered by GeneDx will give UC Health’s world class doctors, genetic counselors and other clinicians actionable insight into some of the most pressing health challenges faced by their patients and could expand the potential for their research to produce good outcomes.” GeneDx offers UC Health unique tools for understanding cancer, rare diseases, prenatal conditions, and some of the most difficult problems in medical diagnosis through a comprehensive menu of genetic and genomic tests that will supplement UC Health’s testing infrastructure across its medical centers at the UC Health campuses. An important differentiator is GeneDx’s advanced analytic tools, which not only provide the highest level of genetic testing, but also the technology to add insight to the findings. GeneDx has developed a unique,  clinician focused population health tool that allows end users to better manage and track their data at a cohort or individual level in a protected and compliant manner. About the University of California Founded in 1868, the University of California is a public university system that is considered the most comprehensive and advanced postsecondary educational system in the world.  UC comprises ten college campuses and five medical centers with more than 238,000 students.  For more information, visit https://www.universityofcalifornia.edu/uc-system. About GeneDx GeneDx is a world leader in genomics with an acknowledged expertise in rare and ultra rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. Providing testing to patients and their families in more than 55 countries, GeneDx is a business unit of BioReference Laboratories, a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com. About OPKO Health, Inc.  OPKO Health is a diversified healthcare company that seeks to establish industry leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), OPK88003, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, OPK88004, a SARM (Selective Androgen Receptor Modulator) for treating BPH (Benign Prostatic Hypertrophy), OPK88002, a NK-1 antagonist to treat pruritus ( itching) in dialysis patients, and OPK88001, a proprietary oligonucleotide to treat Dravet syndrome. In addition, the Company is advancing its CTP technology, which includes long acting hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and long acting Factor VIIa drug for hemophilia in phase 2a.  OPKO also has production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding the expected expansion of our relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services, expected benefits from the relationship and the ability to close the gap between data and diagnosis to help ensure good outcomes for individuals, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


Miami, Florida headquartered Opko Health Inc.'s shares gained 0.92%, closing Monday's trading session at $6.59. The stock recorded a trading volume of 4.44 million shares, which was above its three months average volume of 4.06 million shares. Shares of the Company are trading 6.01% below their 50-day moving average. Additionally, shares of Opko Health, which engages in the diagnostics and pharmaceuticals business in the US, Ireland, Chile, Spain, Israel, and Mexico, have a Relative Strength Index (RSI) of 48.83. On June 07th, 2017, Opko Health announced that GeneDx, a business unit of the Company's BioReference Laboratories division, extended its relationship with the University of California Health (UC Health) for genetic, genomic, and molecular testing services. By having access to the latest in next generation genetics and molecular oncology resources, both internally and externally, UC Health remains at the forefront of precision medicine. See our free and comprehensive research report on OPK at: On Monday, shares in Austin, Texas-based Pain Therapeutics Inc. recorded a trading volume of 21,698 shares. The stock rose 2.44%, ending the day at $4.20. The Company's shares have advanced 5.23% on an YTD basis. The stock is trading below its 50-day moving average by 12.18%. Furthermore, shares of Pain Therapeutics, which develops drugs for treating nervous system in the US, have an RSI of 49.33. On June 05th, 2017, Pain Therapeutics announced that the National Institutes of Health (NIH) has awarded the Company a $1.7-million research grant to study PTI-125, a drug candidate in Alzheimer's disease. This NIH research grant will enable the Company to begin testing PTI-125 in human subjects. An Investigational New Drug application for PTI-125 is on-track for submission to the US FDA in Q3 2017. PTIE free research report is just a click away at: King of Prussia, Pennsylvania headquartered Trevena Inc.'s stock finished the day 1.63% higher at $2.49. A total volume of 1.02 million shares was traded, which was above their three months average volume of 625,680 shares. Shares of the Company are trading below their 50-day moving average by 17.38%. Additionally, shares of Trevena, which develops various therapies based on breakthrough science to benefit patients and healthcare providers confronting serious medical conditions, have an RSI of 38.11. On June 02nd, 2017, Trevena announced that it will be attending the JMP Securities Life Sciences Conference on June 21st, 2017, at 8:30 a.m. EDT in New York. Sign up for your complimentary report on TRVN at: Shares in Berkeley, California headquartered Dynavax Technologies Corp. ended yesterday's session 5.73% higher at $8.30. The stock recorded a trading volume of 2.44 million shares, which was above its three months average volume of 1.25 million shares. The Company's shares have surged 48.21% in the last one month, 38.33% over the previous three months, and 110.13% since the start of this year. The stock is trading 40.06% and 24.06% above its 50-day and 200-day moving averages, respectively. Moreover, shares of Dynavax Technologies, which focuses on leveraging the power of the body's innate and adaptive immune responses through toll-like receptor stimulation, have an RSI of 82.34. On June 02nd, 2017, Dynavax Technologies announced the presentation of findings in patients with metastatic melanoma in the dose escalation phase of an ongoing Phase-1b/2 study investigating SD-101, the Company's intratumoral TLR9 agonist, in combination with KEYTRUDA® (pembrolizumab), an anti-PD-1 therapy developed by Merck, known as MSD outside the US and Canada. SD-101 in combination with KEYTRUDA generally was well tolerated. No dose-limiting toxicities of the combination were observed in any dose cohort, and a maximum tolerated dose was not identified. Sign up and read the free research report on DVAX at: Daily Stock Tracker (DST) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and micro-cap stocks. DST has two distinct and independent departments. 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News Article | July 10, 2017
Site: www.prnewswire.com

LONDON, July 10, 2017 /PRNewswire/ -- This report analyzes the worldwide markets for Clinical Laboratory Services in US$ Million by the following Segments: Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Download the full report: https://www.reportbuyer.com/product/4707129/ Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 131 companies including many key and niche players such as: - ADICON Clinical Laboratories, Inc. - ARUP Laboratories - Bio-Reference Laboratories, Inc. - Bioscientia Institut für Medizinische Diagnostik GmbH - DaVita, Inc. Download the full report: https://www.reportbuyer.com/product/4707129/ I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations Disclaimers Data Interpretation & Reporting Level Quantitative Techniques & Analytics Product Definitions and Scope of Study Hospital-Based Medical Laboratories Independent Laboratories Physician Office-Based Laboratories II. EXECUTIVE SUMMARY 1. INDUSTRY OVERVIEW Outlook Developed Nations: Cost Pressures Necessitate New Strategies Despite Challenges, Emerging Markets Provide Growth Opportunities Routine Testing Take the Lead; Esoteric Testing Services Drive Growth Common Routine and Esoteric Tests Key Market Drivers Growth Contributing Factors in a Gist Rising Healthcare Needs of Aging Global Population Table 1: Global Population Statistics for the 65+ Age Group (2015) (includes corresponding Graph/Chart) Table 2: Comparison of Aging Population by Country (1980, 2015 & 2050): Percentage Share of Population Aged Above-65 Years of the Overall Population for Select Countries (includes corresponding Graph/Chart) Table 3: Life Expectancy for Select Countries in Number of Years: 2015E (includes corresponding Graph/Chart) Increase in Healthcare Spending in Emerging Markets Table 4: Healthcare Spending as a Percentage of GDP by Region (2016E) (includes corresponding Graph/Chart) Table 5: Per-Capita Healthcare Expenditure in US$ for Select Countries/Regions (2014) (includes corresponding Graph/Chart) Increasing Awareness Levels Need to Cut Healthcare Costs Rising Incidence of Diseases Major Causes of Fatalities Worldwide Table 6: Fatalities in High Income Countries by Health Disorder (2015 & 2030): Projected Percentage Breakdown of Number of Deaths for CVD, Cancer, Injury, and Others (includes corresponding Graph/Chart) Table 7: Fatalities in Mid Income Countries by Health Disorder (2015 & 2030): Projected Percentage Breakdown of Number of Deaths for CVD; Cancer; Injury; HIV, TB & Malaria; Malnutrition; and Others (includes corresponding Graph/Chart) Table 8: Fatalities in Low Income Countries by Health Disorder (2015 & 2030): Projected Percentage Breakdown of Number of Deaths for CVD; Cancer; Injury; HIV, TB & Malaria; Malnutrition; and Others (includes corresponding Graph/Chart) World Cancer Statistics: Incidence and Mortality Data Table 9: World Cancer Incidence by Geographic Region and Gender (2012): Number of New Cancer Cases Reported (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart) Table 10: World Cancer Mortality by Geographic Region and Gender (2012): Number of Cancer-Related Deaths (in Thousands) for Asia-Oceania, Europe, North America, Latin America & the Caribbean, and Africa (includes corresponding Graph/Chart) Table 11: New Cancer Cases in the World by Affected Site (2012) (In Thousands) (includes corresponding Graph/Chart) Table 12: Global Incidence of Common Cancers in Men (2012): Number of New Cases Reported in Thousands for Lung & Bronchus, Prostate, Colorectal and Liver Cancers (includes corresponding Graph/Chart) Table 13: Global Incidence of Common Cancers in Women (2012): Number of New Cases Reported in Thousands for Breast, Colorectal, Lung & Bronchus and Liver Cancers (includes corresponding Graph/Chart) Table 14: Global Cancer Mortality in Men for Select Cancers (2012): Number of Deaths in Thousands for Lung & Bronchus, Liver, Colorectal and Prostate Cancers (includes corresponding Graph/Chart) Table 15: Global Cancer Mortality in Women for Select Cancers (2012): Number of Deaths in Thousands for Breast, Lung & Bronchus, Colorectal and Liver (includes corresponding Graph/Chart) Cancer Prone Sites based on Age Global HIV Statistics Table 16: HIV Infection Statistics Worldwide: As of 2014 (includes corresponding Graph/Chart) Table 17: Worldwide HIV Prevalence and Incidence (in Million) by Region: 2014 (includes corresponding Graph/Chart) Table 18: Worldwide AIDS Related Deaths by Geographic Region: 2014 (includes corresponding Graph/Chart) Table 19: HIV-Positive Individuals, by Gender (2014): Percentage Breakdown of Women and Men Tested HIV-Positive in all WHO Regions (includes corresponding Graph/Chart) Cardiovascular Disease Statistics Table 20: Fatalities by Heart Conditions - Estimated Percentage Breakdown for Cardiovascular Disease, Ischemic Heart Disease, Stroke, and Others (includes corresponding Graph/Chart) Table 21: Prevalence of Heart Failure in Select Countries (includes corresponding Graph/Chart) Table 22: Global Annual Medical Cost of CVD in US$ Billion: 2010, 2015, 2020, 2025, and 2030 (includes corresponding Graph/Chart) Increasing Role of Clinical Labs in Testing of Infectious Diseases 2. MARKET TRENDS & ISSUES IVD Market Growth: An Indication of Growth in Clinical Labs Market New Technologies and Tests Drive Demand for Specific Testing Increasing Role of Advanced Tests in Clinical Treatment Decision Making Increasing Opportunities in Personalized Medicine and Clinical Trial Services Cancer Testing Market: Opportunity for Clinical Labs Shortened Hospitalization Enhances Significance of Medical Labs Lab Automation Speeds Up Standardization Gains Precedence in the Hunt for Automation Heightened Use of IT Systems in Clinical Laboratories Assessing the Impact of Point-of-Care Testing on Clinical Labs Autoimmune Disease Testing: Labs Seek Cost-Effective & High Productivity Options POLs: Reducing Turnaround Times for Testing POL Market Succumbs to Cost Pressures Laboratory Outsourcing Trend Gains Strength Value-Based Outsourcing of Services to Take Centerstage Challenges Facing Lab Testing Market 3. COMPETITIVE LANDSCAPE A Preview Quest Diagnostics & LabCorp: The Leading Independent Labs Consolidation Activity Continues to Soar Select Major Clinical Laboratory Transactions: 2015 & 2016 Industry Giants Tread on Different Paths in Consolidation Activity 4. CLINICAL LABORATORY SERVICES - AN INTRODUCTION Clinical Laboratory Services What is a Medical Laboratory? Laboratory Medicine Anatomic Pathology Clinical Pathology Types of Tests Conducted in Medical Labs Routine Tests Esoteric Tests Anatomic Pathology Services Types of Clinical Laboratories Hospital-Based Laboratories Physician Office-Based Laboratories Reference Laboratories Potential Customers for Medical Laboratories Work Process in Clinical Labs Specimen Processing & Result Analysis in Clinical Labs Laboratory Information Systems Conducting Lab Tests Key Personnel in Medical Labs Role of Medical Technologists Role of Medical Technicians Analysis, Validation and Interpretation of Results Testing Equipment Bio-Safety Hazards and Equipment Design Essential Bio-safety Equipment in Clinical Laboratories Personal Protection Equipment in Medical Labs Economic Model Followed By Testing Laboratories Revenues Expenses Dichotomy between Customers and Payers in Medical Lab Industry Impact of Environmental Factors on Lab Tests Regulatory Overview Legislative & Regulatory Environment Worldwide GCLP ISO 15189:2003 ISO 15189 Accreditation ILAC 5. SERVICE/PRODUCT INTRODUCTIONS Quest Diagnostics Introduces Antibody Test for Zika Virus Mayo Clinic Launches Zika Antibody Test Quest Diagnostics Introduces CogniSense™ Cognitive Assessment Tool Great Basin Scientific Launches Shiga Toxin Direct Test Laboratory Corporation of America Launches Zika Virus Testing Quest Diagnostics Introduces New Cancer Test Services Laboratory Corporation of America Launches Epi proColon® Colorectal Cancer Test Immunetics to Launch New Services for Invasive Fungal Infections Unilabs Launches Zika Virus Test NeoGenomics Adds Two New Tests to its Biopsy Testing Menu Quest Diagnostics Launches New Test for NSCLC MDxHealth Introduces SelectMDx™ Test for Prostate Cancer NeoGenomics Expands its FISG Testing Repertoire with NeoSITE™ Commonwealth Laboratories Launches IBSchek Blood Test for IBS Mayo Clinic Introduces New Genetic Testing Panels for Cardiac Diseases OPKO Unveils 4Kscore® Blood Test for Prostate Cancer ARUP Laboratories Launches NGS.Web Sequencing Platform Quest Diagnostics Launches BRCAvantage Plus Services Suite for Breast Cancer ARUP Laboratories to Offer HLA Genotyping Tests Quest Diagnostics Launches New Testing Services for Epilepsy Diagnosis 6. RECENT INDUSTRY ACTIVITY Sysmex Inks Agreement with Myanmar's NHL for Improving Clinical Testing BioPharma Services Acquires Assays from Bioanalytical Laboratory Services Quest Diagnostics Joins Hands with AncestryDNA for Genotyping Test Services LabCorp Inks Definitive Deal to Acquire and Merge with Sequenom MDxHealth and Cerba Ink European Distribution Deal for MDxHealth's Prostate Cancer Test Schryver Medical Takes Over Professional Clinical Laboratory Oxford Immunotec Inks Definitive Deal to Acquire Imugen Zora Biosciences and Mayo Medical Team Up for New Plasma Ceramide Tests Quest Diagnostics Introduces New Hepatitis C Testing Capabilities Aurora Diagnostics Takes Over Pacific Pathology Meridian Bioscience Acquires Magellan Biosciences and Magellan Diagnostics Laboratory Corporation of America Acquires Pathology Clinical Research Laboratories Takes Over Suncare Research Laboratories NeoGenomics Acquires Clarient North Shore-LIJ and OPKO Form Alliance for Genetic Testing Services Quest Diagnostics Acquires Clinical Laboratory Partners's Lab Services Business Medytox to Merge with CollabRx OPKO Health Expands Genetic Test Offerings at GeneDx Cinven Acquires Synlab ARUP Secures Group Purchasing Agreement from Novation NeoGenomics Inks Group Purchasing Deal with Premier OPKO Health Acquires Bio-Reference Laboratories BioScience Acquires Select Pharma Laboratories Exosome Diagnostics Introduces CLIA-Certified Lab in Cambridge Cinven Acquires Labco Quest Diagnostics Acquires Laboratory Outreach Service Business of MemorialCare Health System Healthscope Sells Australian Pathology Business Sonic Healthcare to Take Over Medisupport Eurofins Acquires Boston Heart Diagnostic ARUP Laboratories and Labceutics Team Up for Superior Commercial Testing Services TriCore Merges with Rhodes Mérieux NutriSciences Takes Over ABC Research Unilabs Commences Managed Service Offerings to BMI Ross Hall Hospital Laboratory Corporation of America Acquires Covance Thyrocare Technologies Establishes Cytogenetics Division Laboratory Corporation of America Acquires Bode Technology ARUP Laboratories Inks Partnership with PierianDx for Developing Improved Genetic Tests Charles River Laboratories Acquires ChanTest Alpha Medical Acquires Euromedic's Czech Laboratory Eurofins Scientific Inks Definitive Agreement to Take Over ViraCor-IBT Laboratories Myriad Genetics Inks Contract with United Healthcare for myRisk™ Test Quest Diagnostics Acquires Outstanding Stake in Steward's Outreach Laboratory Service Operations Quest Diagnostics Takes Over Summit Health LifeLabs and Contextual Genomics Ink Co-Marketing Deal for New Cancer Tests UCLA, University of California and Centre Testing International Team Up for a New Lab in China Quest Diagnostics Acquires Solstas Lab Partners LifeLabs Acquires Centogene's Canadian Business ACM Medical Laboratory Takes Over Phoenix PCS Gamma-Dynacare Acquires Lab Bio-Medic 7. FOCUS ON SELECT PLAYERS ADICON Clinical Laboratories, Inc. (China) ARUP Laboratories (US) Bio-Reference Laboratories, Inc. (US) Bioscientia Institut für Medizinische Diagnostik GmbH (Germany) DaVita, Inc. (US) Dynacare (Canada) Enzo Clinical Labs (US) Genoptix Medical Laboratory (US) Genova Diagnostics, Inc. (US) Kingmed Diagnostics (China) Laboratory Corporation of America Holdings (US) Mayo Medical Laboratories (US) NeoGenomics Laboratories (US) Quest Diagnostics, Inc. (US) Sonic Healthcare Limited (Australia) American Esoteric Laboratories (US) Spectra Laboratories, Inc. (US) SYNLAB Group (Germany) The National Health Laboratory Service (South Africa) Thyrocare Technologies Limited (India) Unilabs SA (Switzerland) 8. GLOBAL MARKET PERSPECTIVE Table 23: World Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 24: World Historic Review for Clinical Laboratory Services by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 25: World 14-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) Table 26: World Recent Past, Current and Future Analysis for Hospital-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 27: World Historic Review for Hospital-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 28: World 14-Year Perspective for Hospital-Based Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) Table 29: World Recent Past, Current and Future Analysis for Independent Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 30: World Historic Review for Independent Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 31: World 14-Year Perspective for Independent Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) Table 32: World Recent Past, Current and Future Analysis for Physician Office-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 33: World Historic Review for Physician Office-Based Laboratories by Geographic Region - US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 34: World 14-Year Perspective for Physician Office-Based Laboratories by Geographic Region - Percentage Breakdown of Revenues for US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) III. MARKET 1. THE UNITED STATES A.Market Analysis Clinical Laboratories: A Small Yet Vital Constituent of Healthcare Industry Changing Healthcare Industry Dynamics Affect Clinical Lab Testing Market Table 35: Healthcare Spending as a % of GDP: 2001-2014 (includes corresponding Graph/Chart) Positive Outlook for Clinical Laboratory Services Market Current and Future Analysis A Glance at Major Growth Drivers Unmet Diagnostic Needs of Aging Population Table 36: North American Elderly Population by Age Group (1975-2050) (includes corresponding Graph/Chart) Increasing Burden of Chronic Diseases Drives Focus onto Early Detection & Prevention Cancer Statistics in the US Table 37: New Cancer Cases by Gender and Affected Site in the US (2015) (includes corresponding Graph/Chart) Prevalence of Diabetes Mellitus in North America Table 38: Prevalence of Diabetes Mellitus in North America (2012) (includes corresponding Graph/Chart) Opportunities in Personalized Medicine and Clinical Trial Services Growing Focus on Early Diagnosis Impact of Scientific Advances & Role of Healthcare IT Solutions Need to Reduce Healthcare Costs Legislative, Regulatory and Policy Environment Opportunities for Individual Testing Population Screening Initiatives Challenges Facing Clinical Labs Market Key Trends & Issues Product-Related Trends Anatomic Pathology & Cytology Testing: Personalized Medicine Presents Positive Future Esoteric Testing Market: Faster Growth than Routine Testing Segment Molecular Diagnostics: Promising Growth Opportunities Drugs of Abuse Testing: Prospects Linked to Employment Levels Future Holds Promise for Specialty Testing Market Impact of Healthcare Spending Cuts on Routine & Specialty Lab Tests Increasing Role of Advanced Tests in Clinical Treatment Decision Making Tissue-based Diagnostics Market to Expand Toxicology Laboratories Market: An Insight Genetic and Genomic Clinical Lab Testing Market: Promising Prospects Shift towards Managed Care - A Challenge for Independent Clinical Labs? Evolving ACO Business Model: A Challenge for Independent Labs Integration of Clinical Care: Impact on Clinical Labs & Anatomic Pathology Groups Hospital Laboratory Outreach Programs: On the Rise Physician Practices: The New Acquisition Targets Table 39: % of Independent Physicians in the US (2000, 2005 & 2016) (includes corresponding Graph/Chart) Cost Cutting Measures to Hit Lab Outreach Testing Business? Hospitals Foray into Health Insurance Market: Opportunities for Hospital Labs Shortened Hospital Stay Enhances Significance of Medical Labs Lab Automation: A Key Trend in the Clinical Laboratory Testing Market Health Plans Interpose Between Clinical Labs and Physicians POCT Segment Withstands Cost Pressures Quality Concerns Bring Information Technologies to the Fore Move towards IQCP Remains Lethargic Dealing with Regulatory Changes: A Tough Ask for Clinical Labs A Peek into Reimbursement Environment for Clinical Lab Services Regulation of LDTs Hangs in Balance Competitive Landscape Providers of Clinical Laboratory Service in the US: A Review Hospital-Based Labs Table 40: Registered Hospitals in the US by Type: 2017 (includes corresponding Graph/Chart) Independent Labs Table 41: Independent Labs Market in the US (2016E): Percentage Share Breakdown of Revenues for LabCorp, Quest Diagnostics, Small Independent Labs and Others (includes corresponding Graph/Chart) Physician Office-Based Labs and Others Consolidation Activity Gathers Pace in Clinical Laboratory Testing Market Table 42: Number of Closed M&A Transactions in the US Clinical Labs Market (2005-2013) (includes corresponding Graph/Chart) Table 43: Closed M&A Transactions in the US Clinical Labs Market (2009-2013): Breakdown by Clinical Labs and Anatomic Pathology & Specialty Labs (includes corresponding Graph/Chart) Regulatory Landscape Select Major Regulations A2LA ASCLS CAP Clinical Laboratory Improvement Amendments (CLIA) Table 44: CLIA-Certified Laboratories in the US (2015): Percentage Share Breakdown of Number of Laboratories by Certificate Type (includes corresponding Graph/Chart) Table 45: CLIA-Certified Laboratories in the US (2016): Percentage Share Breakdown of Number of Labs by Lab Type (includes corresponding Graph/Chart) PAMA to have A Major Impact on Impact Clinical Laboratory Market Health Insurance Portability and Accountability Act of 1996 FDA Regulations Substance Abuse and Mental Health Services Administration (SAMHSA) Regulation Medicare Coverage for Screening Tests Medicare Clinical Laboratory Fee Schedule (CLFS) Medicare Physician Fee Schedule (MPFS) Medicaid Table 46: Medicare Spending in the US (2015): Percentage Share Breakdown of Spending by Category - Inpatient Hospital, Medicare Advantage, Outpatient Hospital, Physician Fee Schedule, Prescription Drugs and Others (includes corresponding Graph/Chart) Service Launches Strategic Corporate Developments Key Players B.Market Analytics Table 47: US Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 48: US Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 49: US 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 2. CANADA A.Market Analysis Outlook Rising Incidence of Chronic Diseases Spurs Need for Testing Table 50: New Cancer Cases in Canada (2016): Percentage Breakdown of Cancer Incidence by Gender and Affected Site (includes corresponding Graph/Chart) Table 51: New Cancer Cases in Canada by Province (2016) (includes corresponding Graph/Chart) Table 52: Cancer Incidence in Canada by Age Group and Gender: Age Standardized Incidence Rate per 100,000 People (2015) (includes corresponding Graph/Chart) Regulatory Scenario in Canada Accreditation Canada Standards Council of Canada Strategic Corporate Developments Dynacare - A Key Player B.Market Analytics Table 53: Canadian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 54: Canadian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 55: Canadian 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 3. JAPAN A.Market Analysis Outlook Physician Office Labs Play Limited Role in Lab Services Demographics Drive Market Growth Table 56: Percentage Distribution of Japanese Population by Age Group: 2015 (includes corresponding Graph/Chart) Table 57: Prevalence of Diabetes Mellitus in Japan (2012 & 2030) (includes corresponding Graph/Chart) B.Market Analytics Table 58: Japanese Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 59: Japanese Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 60: Japanese 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4. EUROPE A.Market Analysis Outlook Table 61: Diagnostics Market in Europe (2016E): Percentage Share Breakdown of Revenues by Medical Imaging, Laboratory Testing, and Anatomic Pathology (includes corresponding Graph/Chart) European Healthcare System: In a State of Transition? Aging Population to Drive Demand for Medical Laboratory Services Table 62: Population Breakup by Age Group for EU-28 Countries: 2015 (As a Percentage of Total Population) (includes corresponding Graph/Chart) A Peek into the Competitive Landscape Select Leading Players Synlab-Labco Combination Alters Market Landscape Accreditation and Regulatory Scenario in the EU B.Market Analytics Table 63: European Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 64: European Historic Review for Clinical Laboratory Services by Geographic Region - France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 65: European 14-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for France, Germany, Italy, UK, Spain, Russia and Rest of Europe Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) Table 66: European Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 67: European Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 68: European 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4a. FRANCE A.Market Analysis Outlook Market Overview Table 69: Percentage Distribution of French Population by Age Group: 2015 (includes corresponding Graph/Chart) Complex Regulations Slow Down Industry Consolidation Table 70: Leading Players in the French Clinical Laboratory Services Market (2015): Percentage Breakdown of Revenues for Cerba/Novescia, Eurofins, Labco, Unilabs and Others (includes corresponding Graph/Chart) Strategic Corporate Development B.Market Analytics Table 71: French Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 72: French Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 73: French 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4b. GERMANY A.Market Analysis Outlook Physician Office Lab Market Fails to Gather Momentum Privatization: A Visible Trend in the Labs Market Regulatory Scenario in Germany DAkkS GmbH - Germany's National Accreditation Body Strategic Corporate Development Key Players B.Market Analytics Table 74: German Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 75: German Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 76: German 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4c. ITALY A.Market Analysis Outlook ACCREDIA - The Italian Accreditation Body B.Market Analytics Table 77: Italian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 78: Italian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 79: Italian 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4d. THE UNITED KINGDOM A.Market Analysis Outlook UKAS - The Sole National Accreditation Body in the UK Strategic Corporate Developments B.Market Analytics Table 80: UK Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 81: UK Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 82: UK 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4e. SPAIN Market Analysis Table 83: Spanish Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 84: Spanish Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 85: Spanish 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4f. RUSSIA Market Analysis Table 86: Russian Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 87: Russian Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 88: Russian 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 4g. REST OF EUROPE A.Market Analysis Outlook Focus on Select Regional Markets Switzerland Overview Physician Office Labs Market Goes Strong in Swiss Poland Ukraine Service Launches Strategic Corporate Developments Unilabs Sa (Switzerland) - A Key Player B.Market Analytics Table 89: Rest of Europe Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 90: Rest of Europe Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 91: Rest of Europe 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 5. ASIA-PACIFIC A.Market Analysis Overview Healthcare Spending in Asia-Pacific: On the Rise China and India: Two Fast-Growing Markets APLAC - A Regional Accreditation Body in Asia-Pacific B.Market Analytics Table 92: Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Geographic Region - China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 93: Asia-Pacific Historic Review for Clinical Laboratory Services by Geographic Region - China and Rest of Asia-Pacific Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 94: Asia-Pacific 14-Year Perspective for Clinical Laboratory Services by Geographic Region - Percentage Breakdown of Revenues for China and Rest of Asia-Pacific Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) Table 95: Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 96: Asia-Pacific Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 97: Asia-Pacific 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 5a. CHINA A.Market Analysis Outlook Medical Labs Market: An Overview Healthcare Reforms: Opportunities for Clinical Labs Market Drive to Improve Access to Healthcare Fuels Growth in Independent Clinical Laboratories Table 98: Leading Independent Medical Labs in China (2015): Percentage Breakdown of Revenues for Adicon Clinical Laboratories, DiAn Diagnostics, KingMed Diagnostics and Others (includes corresponding Graph/Chart) Industry Leaders Look to Expand Beyond Clinical Services CNAL - The National Accreditation Body in China HKAS - An Accreditation Body in Hong Kong Strategic Corporate Development Key Players B.Market Analytics Table 99: Chinese Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 100: Chinese Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 101: Chinese 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 5b. REST OF ASIA-PACIFIC A.Market Analysis Outlook Review of Select Regional Markets Australia NATA - An Australian Regulatory Agency India Clinical Laboratory Market: Overview Growth Drivers Challenges Biochemistry Analysis: An Important Clinical Lab Segment Table 102: Indian Clinical Laboratory Market (2016E): Percentage Share Breakdown of Revenues by Segment - Biochemistry, Immunology, Hematology, Microbiology, Histopathology, Molecular, and Genetics (includes corresponding Graph/Chart) Competitive Landscape Business Model of Medical Labs Table 103: Indian Medical Laboratories Market (2013)): Number of Labs and Collection Centers Operated by Metropolis, SRL Diagnostics, and Dr. Lal Path Labs Regulatory Scenario in India Indonesia Korea Rapidly Aging Population Spurs Demand for Clinical Lab Testing KOLAS - The National Accreditation Agency of Korea Philippines Regulatory Scenario in Philippines Singapore SAC - The National Agency for Accreditation in Singapore Thailand BLQS - A Designated Accreditation Authority in Thailand Strategic Corporate Developments Key Players B.Market Analytics Table 104: Rest of Asia-Pacific Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 105: Rest of Asia-Pacific Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 106: Rest of Asia-Pacific 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 6. LATIN AMERICA A.Market Analysis Outlook Brazil Overview INMETRO - The National Accreditation Body of Brazil Chile Service Launch B.Market Analytics Table 107: Latin American Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 108: Latin American Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 109: Latin American 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) 7. REST OF WORLD A.Market Analysis Outlook Medical Laboratories in Sub-Saharan Africa East Africa West Africa Nigeria South Africa Regulatory Environment in South Africa The National Health Laboratory Service (South Africa) - A Key Player B.Market Analytics Table 110: Rest of World Recent Past, Current and Future Analysis for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2015 through 2022 (includes corresponding Graph/Chart) Table 111: Rest of World Historic Review for Clinical Laboratory Services by Location - Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets Independently Analyzed with Annual Revenue Figures in US$ Million for Years 2009 through 2014 (includes corresponding Graph/Chart) Table 112: Rest of World 14-Year Perspective for Clinical Laboratory Services by Location - Percentage Breakdown of Revenues for Hospital-Based Laboratories, Independent Laboratories, and Physician Office-Based Laboratories Markets for Years 2009, 2016 & 2022 (includes corresponding Graph/Chart) IV. COMPETITIVE LANDSCAPE Total Companies Profiled: 131 (including Divisions/Subsidiaries - 143) The United States (98) Canada (11) Japan (1) Europe 15) - France (2) - Germany (2) - The United Kingdom (5) - Rest of Europe (6) Asia-Pacific (Excluding Japan) (9) Middle East (4) Africa (5) Download the full report: https://www.reportbuyer.com/product/4707129/ About Reportbuyer Reportbuyer is a leading industry intelligence solution that provides all market research reports from top publishers http://www.reportbuyer.com For more information: Sarah Smith Research Advisor at Reportbuyer.com Email: query@reportbuyer.com Tel: +44 208 816 85 48 Website: www.reportbuyer.com


News Article | November 7, 2016
Site: globenewswire.com

MIAMI, Nov. 07, 2016 (GLOBE NEWSWIRE) --  OPKO Health, Inc. (NASDAQ:OPK), reports financial and operating results for the three months ended September 30, 2016. “We are finalizing the details of our commercial launch of RAYALDEE and have completed the selection and hiring of a very talented commercial team, all of whom bring deep relationships in the nephrology and specialty pharmaceutical sales market,” stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.  “RAYALDEE will be an important medicine for a large number of chronic kidney disease patients suffering from SHPT and vitamin D insufficiency.  We are working closely with the Vifor Fresenius Medical Care Renal Pharma team to bring RAYALDEE  to market outside the U.S. and are presently planning the start of a Phase 3 trial in dialysis patients which  represents the first potential line extension for RAYALDEE in addition to its currently approved indication. “With the Transition Therapeutics acquisition, we now have two additional important drugs in Phase 2 development; one for patients who could benefit from its effects on increasing bone and muscle strength while decreasing fat mass; the other for type 2 diabetes and obesity.  Each drug has already been studied and shown to be safe in approximately 400 patients.  We are also very pleased to now have the benefit of an experienced Transition Therapeutics team led by its CEO, Tony Cruz. “Our BioReference Laboratories and its GeneDx unit continue to grow and the utilization of our innovative 4Kscore test for predicting the probability of aggressive prostate cancer remains strong. Last, we have made great progress on our Claros point of care diagnostic system and anticipate starting clinical trials for our PSA and testosterone tests in the coming months,” continued Dr. Frost. OPKO’s senior management will provide a business update and discuss results in greater detail  in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial in information is listed below. To access the webcast, please log on to the OPKO website at www.opko.com. For those unable to participate in the conference call or webcast, a replay will be available beginning November 7, 2016 at 7:30 p.m. ET for a period of time. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 12830677. The replay can also be accessed for a period of time on OPKO’s website at www.opko.com. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency, VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation PDUFA date: January 2017), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications.  Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in phase 2a) and a long-acting oxyntomodulin for diabetes and obesity (in phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance, our product development efforts and the expected benefits of our products, including whether our ongoing and future clinical trials will be completed on a timely basis or at all and whether the data from any of our trials will support approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, including RAYALDEE, the expected timing of commencing and concluding our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, the timing of our regulatory submissions, our ability to market and sell any of our products in development, expectations about developing RAYALDEE for dialysis patients, our ability to obtain broad reimbursement coverage for the 4Kscore test, increased adoption rates for the 4Kscore, our expectations about the Transition Therapeutics products in development, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as integration challenges for Bio-Reference, EirGen, Transition, and other acquired businesses, the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the 4Kscore, RAYALDEE, Varubi™, hGH-CTP, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


MIAMI, Feb. 28, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), today announces that GeneDx, a subsidiary of OPKO Health, is proud to participate as a founding member in Illumina Inc.’s (NASDAQ:ILMN) iHope Network on International Rare Disease Day, which takes place today.  iHope Network is led by a group of clinical laboratory partners committed to providing clinical whole-genome sequencing (cWGS) to children with undiagnosed rare diseases. The iHope program aims to offer this advanced technology to help end diagnostic odysseys that these patients and their families endure. In addition to GeneDx, the iHope Network currently consists of the following institutions: Illumina, the Garvan Institute of Medical Research, and Hudson Alpha. As an iHope Network partner, GeneDx has committed to donating 10 whole-genome sequencing tests per year. The variants identified through testing will be shared via public variant databases including ClinVar. By sharing this variant information, GeneDx continues its long-standing commitment to sharing data for better patient care while also contributing to the rare disorder community through further collaboration and research. “We are thrilled to have GeneDx as a founding member of the iHope Network, which will transform the lives of pediatric patients with limited access to resources and who need a genetic diagnosis quickly. As a leader in the field, GeneDx’s clinical whole-genome testing will prove invaluable to these families,” said Ryan Taft, PhD, Senior Director of the Scientific Research Population and Medical Genomics Department, Illumina. GeneDx was founded in 2000 by two scientists from the National Institutes of Health (NIH) with a mission to provide diagnostic testing for patients with rare and ultra-rare disorders. Today, GeneDx has grown into a global industry leader in genomics, having provided testing to patients and their families in over 55 countries. Led by its world-renowned whole exome sequencing program, and an unparalleled comprehensive genetic testing menu, GeneDx has a continued expertise in rare disorders. Both GeneDx and the iHope program strive to provide answers to those affected by rare diseases and to increase awareness for these disorders. “We are delighted to become a participating partner of Illumina’s iHope Network,” said Jane Juusola, PhD, FACMG, Director of the Clinical Genomics Program, GeneDx. “As a laboratory founded to address the needs of patients diagnosed with rare genetic diseases, the very principle of the iHope program aligns with our founding mission. Through our donation of 10 whole-genome sequencing tests, we hope to bring closure to the diagnostic odysseys for children with undiagnosed rare diseases.” GeneDx is a world leader in genomics with an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx provides testing to patients and their families in more than 55 countries.  GeneDx is a business unit of BioReference Laboratories, a wholly owned subsidiary of OPKO Health, Inc.  To learn more, please visit www.genedx.com. For GeneDx’s complete list of testing options, please visit www.genedx.com or email genedx@genedx.com.  Follow on Twitter @GeneDx and become a fan on Facebook @GeneDxLab to get real-time updates. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes BioReference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications. Our biologics business includes hGH-CTP, a once weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), a long-acting oxyntomodulin for diabetes and obesity (in Phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), and such statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of the iHope program, that it will benefit patients with rare disease and better patient care, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


ATLANTA, GA, December 01, 2016-- Sequencing.com, an online platform where people can securely store their genetic data and find apps that make genetic data understandable and useful, and Concierge Medicine Today (CMT), the premier publication in Concierge Medicine, have announced a partnership to help put Whole Genome Sequencing (WGS) technology into the hands of Concierge physicians.Through this partnership, Concierge Medicine Physicians now have access to Whole Genome Sequencing services designed specifically for the practicing healthcare provider. The process is both non-invasive and simple: a saliva-collection kit is used to collect a saliva sample, which is then sent to a state-of-the-art laboratory that is a member of Sequencing.com's Preferred Provider Network of genetic testing providers.The laboratory isolates the person's DNA from the saliva and sequences the person's whole genome at 30X coverage. The massive amount of data generated by the lab is then securely transferred to Sequencing.com and made available to each physician. From there, the physician can use apps available at Sequencing.com to generate straightforward, actionable reports. The offer includes lifetime storage of the genetic data and two reports focused on wellness & longevity.Concierge Medicine Today and Sequencing.com predict the widespread use of genome sequencing by [Concierge] physicians in daily clinical patient care. Previously available only in academic medical centers, this advanced healthcare technology provides the ability to predict and prevent disease. Due to decreasing costs and better understanding about how to make genetic data actionable, this advanced technology is moving out of academia and is now fully accessible to Concierge physicians."The genetic revolution has already begun, and it is having far-reaching effects on healthcare right now," said Brandon Colby, MD, a medical doctor, author of Outsmart Your Genes and Sequencing.com's Founder and CEO. "Our knowledge of how to use this information is increasing at an exponential rate. What this means is that we can now start to integrate genetics into our everyday lives. With comprehensive genetic testing, we launch an innovative strategy against disease, attacking it before it even manifests. Whole Genome Sequencing, therefore, provides a new counter-offensive in our war against Alzheimer's, cancer, heart disease, and many other diseases that have plagued our civilization for centuries. This is the most exciting, and potentially groundbreaking, medical development of this century.""DNA data with the continuous interaction and direction of a [Concierge] physician ushers in a healthcare utopia. In this way, it simplifies decision making using insights obtained from each person's genetic data," said Michael Tetreault, Editor of Concierge Medicine Today."Genetic technology has reached the point where the cost of conducting comprehensive genetic testing [ie. Whole Genome Sequencing] for hundreds of preventable diseases at a single time is now affordable," said Catherine Sykes, CEO, and Publisher of the national trade publication. "After years of thoughtful consideration, careful research and review, countless hours of dialogue with various physicians and technology companies, we encourage Concierge Medicine Physicians to make personal genomic data information available to patients so that they can start to understand their makeup, learn more about their individual genome and predictors and begin to use these insights to improve their lives.""Anything that moves us toward the realization of better outcomes using data and evidence-based medicine gets a green light by Concierge Medicine Today," says Sykes. "Whole Genome Sequencing provides the data needed for Concierge physicians to be able to integrate personalized precision medicine into their practice."To learn more about Concierge Medicine and Whole Genome Sequencing, visit www.ConciergeMedicineToday.com About Concierge Medicine TodayConcierge Medicine Today (CMT) is a news organization and the Concierge Medicine industry's oldest national trade publication for the Concierge Medicine and Membership Medicine marketplaces. Its website is the online destination for businesses, consumers, physicians, legislators, researchers and other stakeholders to learn about the history of this industry, various business aspects of the marketplace, trends, breaking news and more that drives the conversation that Concierge Medicine and free market healthcare delivery is creating on a national and international level. Concierge Medicine Today recently released their Position Statement on Whole Genome Sequencing. For more information, visit: www.GeneticConciergeMedicine.com or www.ConciergeMedicineToday.com About Sequencing.comSequencing.com's first-of-its-kind HIPAA-compliant platform allows people to obtain meaning and value from their genes. The platform includes an App Market with dozens of apps that empower individuals, researchers, bioinformaticians and healthcare professionals to tap into genetic data for deep and rich insights. It is a one-stop-shop that collates and organizes available genetic-based apps into a single online marketplace.Sequencing.com's platform is fully compatible with all genetic data formats and technologies, including Whole Genome Sequencing, exome sequencing, microarrays, and genealogy-focused DNA tests. Data generated by almost any genetic data can be stored and made useful at Sequencing.com including genetic tests offered by Illumina, BGI, Thermo Fisher, GeneDx, Ambry Genetics, Helix, National Geographic, Ancestry.com and 23andMe.


SAN DIEGO--(BUSINESS WIRE)--Illumina, Inc. (NASDAQ:ILMN) today announced the launch of the iHope Network, a consortium of member institutions who have committed to providing clinical whole genome sequencing (cWGS) to underserved families. Today, the iHope Network consists of clinical laboratory members: Illumina, Genome.One, GeneDx, HudsonAlpha and their affiliate healthcare partners. Through whole-genome sequencing – the process of determining the genetic code or instructions in the cells within a person’s body – the iHope Network and their respective clinical partners strive to end years-long diagnostic odysseys. These odysseys average seven years in length and include multiple inconclusive tests, surgeries and procedures, many of which do not result in answers or treatment options for these children and their families. The iHope Network members have committed to a minimum philanthropic donation of 10 whole genome tests per year (10 patients). Additionally, iHope Network organizations have agreed to donate the variants identified through iHope to public databases, like Clinvar, which are freely accessible, public archives of reports of the relationships among human variations and their related symptoms or diseases. By doing so, the public wealth of knowledge will continue to grow and provide benefit to many more patients who depend on the precision of genomic medicine. With precision medicine and large-scale genomic initiatives being launched across the globe, genomics is reaching an inflection point in public awareness. The iHope program aims to build on that public awareness by demonstrating how next-generation sequencing can create a significant impact – by helping undiagnosed patients and their families find long sought-after answers. “We are delighted to become a participating partner of Illumina’s iHope Network” said Jane Juusola, PhD, FACMG, Director of the Clinical Genomics Program, GeneDx. “As a laboratory founded to address the needs of patients diagnosed with rare genetic diseases, the very principle of the iHope program aligns with our founding mission. Through our donation of 10 whole-genome sequencing tests, we hope to bring closure to the diagnostic odysseys for children with undiagnosed rare diseases.” “We’ve seen firsthand how a diagnosis can help families get a clearer understanding of the journey ahead,” said Marcel Dinger, CEO of Genome.One, a wholly owned subsidiary of the Garvan Institute of Medical Research. “We’re very pleased to be part of the iHope Network that will help people who are currently unable to access clinical whole-genome sequencing and help to raise awareness about the value of WGS for rare and genetic disease.” “The evidence is clear that genomic medicine can directly benefit patients. And there are millions of patients who need whole-genome sequencing today, and who cannot afford it,” said Howard J. Jacob, Ph.D., Executive Vice President for Genomic Medicine and Chief Genomic Medicine Officer, HudsonAlpha Institute for Biotechnology. “The more people who are helped through this initiative, the better the likelihood whole-genome sequencing will be integrated into clinical practice around the globe. We are proud to join the iHope Network and help save lives.” The ultimate goal of the iHope Network is to increase awareness and adoption of cWGS and demonstrate to the community that clinical whole genomes are a needed resource for all pediatric patients facing rare and undiagnosed diseases. An iHope Network Summit will take place later this year. To learn more about the program or to become part of the iHope Network, please visit: www.illumina.com/ihope. GeneDx is a world leader in Genomics with an acknowledged expertise in rare and ultra rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx provides testing to patients and their families in more than 55 countries. GeneDx is a business unit of BioReference Laboratories, a wholly owned subsidiary of OPKO Health, Inc. To learn more, please visit www.genedx.com. About Genome.One and the Garvan Institute of Medical Research Genome.One (www.genome.one) is a pioneering health information company providing genetic answers to life’s biggest health questions through clinical Whole Genome Sequencing. Genome.One aims to enhance the lives of patients, families and communities across the world. Genome.One is a wholly owned subsidiary of the Garvan Institute of Medical Research, Sydney, Australia. Garvan’s mission is to make significant contributions to medical science that will change the directions of science and medicine and have major impacts on human health. HudsonAlpha Institute for Biotechnology is a nonprofit institute dedicated to innovating in the field of genomic technology and sciences across a spectrum of biological challenges. Opened in 2008, its mission is four-fold: sparking scientific discoveries that can impact human health and well-being; bringing genomic medicine into clinical care; fostering life sciences entrepreneurship and business growth; and encouraging the creation of a genomics-literate workforce and society. The HudsonAlpha biotechnology campus consists of 152 acres nestled within Cummings Research Park, the nation’s second largest research park. Designed to be a hothouse of biotech economic development, HudsonAlpha’s state-of-the-art facilities co-locate nonprofit scientific researchers with entrepreneurs and educators. The relationships formed on the HudsonAlpha campus encourage collaborations that produce advances in medicine and agriculture. Under the leadership of Dr. Richard M. Myers, a key collaborator on the Human Genome Project, HudsonAlpha has become a national and international leader in genetics and genomics research and biotech education, and includes more than 30 diverse biotech companies on campus. To learn more about HudsonAlpha, visit: http://hudsonalpha.org/. Illumina is improving human health by unlocking the power of the genome. Our focus on innovation has established us as the global leader in DNA sequencing and array-based technologies, serving customers in the research, clinical and applied markets. Our products are used for applications in the life sciences, oncology, reproductive health, agriculture, and other emerging segments. To learn more, visit www.illumina.com and follow @illumina.

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