Clinical Laboratory

Rome, Italy

Clinical Laboratory

Rome, Italy
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What's the Size of the Clinical Laboratory Market in Several Country Markets? Global Laboratory Market: by-Country Market Analysis (U.S., China, Japan, Germany, France, Spain, Italy, Brazil, EMEA and others) provides an overview of the clinical laboratory industry and the trends driving growth. Market data presented include the following: Internationally, the clinical laboratory market is growing. Clinical Laboratory Services Market presents information as a global focused market report. Key regions discussed include Northern America; Europe, Middle East, and Africa (EMEA); Asia Pacific; and Latin America. Datasets provided include the following: - Estimated U.S. Laboratory Service Revenues and Market Share of Leading Clinical Laboratory Providers, 2016 - Estimated U.S. Laboratory Service Revenues for Leading Clinical Laboratory Providers, 2010 vs. 2016 Trends and Issues discussed in this report are inclusive of population statistics,  disease statistics, new issues, regulatory environment, laboratory regulation, reimbursement, payer types, and developments in personalized medicine. The clinical laboratory market is highly competitive in terms of prices, locations, and services offered. Larger laboratories have advantages in the market due to the wide exposure, large number of locations, and greater financial positions. The report profiles companies that are the leaders in the industry, including: 3: Issues And Trends In The Clinical Laboratory Industry - Certificate of Compliance and Certificate of Accreditation - ALERE, Inc - Bio-Reference Laboratories - OPKO - Davita Healthcare Partners, Inc. - Genomic Health, Inc. - Genomic Health, Inc. - Laboratory Corporation of America - Myriad Genetics, Inc. - Neogenomics, Inc. - Quest Diagnostics, Inc. - Siemens Healthineers - Sonic Healthcare Limited - Spectra Laboratories: A Fresenius Company - Synlab International Gmbh For more information about this report visit http://www.researchandmarkets.com/research/m9hsjn/global_clinical Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call +1-917-300-0470 For U.S./CAN Toll Free Call +1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/research-and-markets---global-clinical-laboratory-market-analysis-2010-2021-market-leaders-are-quest-diagnostics-bio-reference-laboratories-opko-genomic-health-laboratory-corporation-of-america--myriad-genetics-300462442.html


"We know imaging has limitations, especially among women under age 50 who, because of confounding factors, are more difficult to image. This research shows that Videssa Breast can be a powerful new tool in the diagnostic toolbox for clinicians." The study, "A Non-Invasive Blood-Based Combinatorial Proteomic Biomarker Assay to Detect Breast Cancer in Women Under the Age of 50 Years" (http://dx.doi.org/10.1016/j.clbc.2017.05.004) demonstrated the performance of Videssa Breast from two prospective trials that enrolled  545 women, ages 25-50, with abnormal or difficult-to-interpret imaging (BI-RADS 3 and 4). The overall performance of Videssa Breast in women with a breast cancer prevalence of 5.87 percent, resulted in a sensitivity of 87.5 percent, specificity of 83.8 percent, positive predictive value (PPV) of 25.2 percent and a negative predictive value (NPV) of 99.1 percent. The study notes that the high NPV helps clinicians identify patients who are highly unlikely to have breast cancer. Depending on age, approximately 70 to 90 percent of breast biopsies are benign.1,2  The improved PPV of Videssa Breast over imaging – 25.2 percent vs. 8.8 percent – can increase the percentage of biopsies that yield a breast cancer diagnosis from one in 11 to one in four. "When a mammogram yields an abnormal result, the challenge for every clinician is to decide which patients need follow-up, further imaging or biopsy," said Josie R. Alpers, MD, a radiologist specializing in mammography and diagnostic radiology at Avera McKennan Hospital & University Health Center and a study co-author. "A test that is well-validated in a prospective trial means clinicians have a new way to accurately identify which patients may or may not need additional follow-up." Videssa Breast has been studied in two prospective, randomized, multi-center and blinded clinical trials, in more than 1,350 patients ages 25-75. It is the first prospective study of a proteomic assay composed of serum protein biomarkers and tumor-associated autoantibodies being used to detect breast cancer in women with abnormal imaging results. The data featured in the current Clinical Breast Cancer publication is taken from the first study and cohort one of the second study. Data from the over 50 cohort will be featured in upcoming publications. Videssa Breast is currently in limited clinical use through an early access program. About Videssa® Breast Videssa® Breast is the first blood-based proteomic test of its kind to provide early and accurate detection of breast cancer. In women who present with abnormal or difficult-to-interpret mammography results, the decision whether to order additional imaging or biopsy can be difficult. With a simple blood draw, Videssa Breast can help guide further diagnostic procedures or provide assurance that the patient does not have breast cancer. Videssa Breast transforms the breast cancer detection paradigm and applies proteomic testing to bring clarity to imaging results. When used in combination with imaging, Videssa Breast improves diagnostic accuracy and provides greater confidence and clarity when clinical assessment is challenging. About Provista Provista Diagnostics is a privately held molecular diagnostics company focused on developing and commercializing a new generation of proprietary blood-based proteomic diagnostic, prognostic and monitoring tests designed to address the unmet needs in women's cancer, such as breast and gynecologic cancers. Provista Diagnostics' state-of-the-art, high-complexity clinical laboratory is accredited by the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). Additional information about Provista Diagnostics is available at ProvistaDx.com. Information about Provista Diagnostics' clinical trials is available at ClinicalTrials.gov. About Clinical Breast Cancer  Clinical Breast Cancer is a peer-reviewed bimonthly journal that publishes original articles describing various aspects of clinical and translational research of breast cancer. Clinical Breast Cancer is devoted to articles on detection, diagnosis, prevention, and treatment of breast cancer. The main emphasis is on recent scientific developments in all areas related to breast cancer. Notes for editors The article is "A Non-Invasive Blood-Based Combinatorial Proteomic Biomarker Assay to Detect Breast Cancer in Women Under the Age of 50 Years" (http://dx.doi.org/10.1016/j.clbc.2017.05.004)," by David E Reese, Ph.D. et al. It appeared online ahead of print May 23, 2017 in Clinical Breast Cancer, published by Elsevier. Copies of this paper are available to credentialed journalists upon request; please contact Elsevier's Newsroom at newsroom@elsevier.com or +31 20 485 2492. Safe Harbor Statement Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Provista's actual results may differ materially due to a number of factors, many of which are beyond Provista's ability to predict or control, including among others, viability and effectiveness of our sales approach and overall marketing strategies, the outcome of development or regulatory review of our products, commercial success or acceptance by the medical community, competitive responses, our ability to raise additional capital, and the ability to successfully file a registration statement with the SEC. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. Provista operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Provista undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. 1 Gur D, Wallace LP, Klym AH, et al. Trends in Recall, Biopsy, and Positive Biopsy Rates for Screening Mammography in an Academic Practice. Radiology 2005 235:2, 396-401 2 Data on file, Provista Diagnostics To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/new-study-blood-test-offers-improved-breast-cancer-detection-new-tool-to-reduce-use-of-breast-biopsy-300461820.html


BIRMINGHAM, Ala.--(BUSINESS WIRE)--Circulogene has announced the addition of three new cfRNA-based tests to its liquid biopsy testing capabilities. The new cfRNA additions include testing for ALK and ROS1 gene fusions and PD-L1 expression – associated with non-small cell lung cancer (NSCLC) – enabling actionable, targeted NSCLC treatment. Lung cancer is one of the most common cancers and the leading cause of cancer death in the U.S. and worldwide, with NSCLC accounting for the majority of cases according to the American Cancer Society and global cancer statistics. Circulogene’s ALK and ROS1 tests cover more than 90 percent of clinically relevant gene fusions associated with treatment decision-making for targeted therapy (crizotinib, ceritinib and brigatinib) for NSCLC patients. “Only a handful of liquid biopsy companies can offer both cfDNA- and cfRNA-based CLIA-validated tests, and even fewer can deploy both NGS and real-time PCR platforms,” said Circulogene Chief Operating Officer Scott Rezek. “We now have the capability to develop, validate and commercialize the complete spectrum of liquid biopsy molecular diagnostics to the medical and scientific community.” Non-invasive liquid biopsies represent a major advance over traditional surgical tumor biopsies, which are costly, time consuming and only sample a small portion of tumor tissue, leading to a high failure rate. Multiple surgical biopsies are also not practical, particularly with NSCLC. Liquid biopsy patients benefit from improved outcomes, and molecular testing of NSCLC is now widely recommended by oncology societies. Circulogene’s extraction-free, proprietary cell-free nucleic acid enrichment capabilities result in near-full recovery of genetic material from droplet volumes of blood, collecting more than 100 times more cfDNA/cfRNA with just 1/10 of the blood (as little as 20 microliters) compared to the current industry standard for non-invasive liquid biopsy testing. Furthermore, unlike other laboratories, Circulogene requires only a single blood sample tube for both the DNA and RNA tests. Once cancer has been diagnosed in a patient, Circulogene’s laboratory can report testing results back to physicians in a matter of days to aid them in selecting the right therapy at the right time for each patient’s unique situation. Circulogene’s cfRNA-based testing results can be reported within one week. “The ability to identify and track actionable cancer mutations is leading to a major shift in the molecular diagnosis and treatment of lung and other cancers,” said Circulogene Chief Scientific Officer Chen-Hsiung Yeh, Ph.D. “Liquid biopsy, tumor-specific cfDNA and cfRNA detection offers significant benefits over conventional protein biomarkers and imaging technology. As therapies targeting ALK and ROS1 gene fusions and PD-L1 expression expand, the accurate, timely and cost-efficient detection of these biomarkers will be critical in delivering optimal treatment to NSCLC cancer patients.” Circulogene is the first and only biotechnology company able to enrich circulating cell-free DNA from blood-drop volumes for patient-specific monitoring of cancer, achieving maximal output from minimal input. The company’s liquid biopsy testing is capable of detecting nearly 3000 cancer mutations on 50 well-established cancer-associated genes for its 14 cancer profiles. Circulogene currently provides testing for breast, colorectal, lung, gastric, gastrointestinal stromal (GIST), hematological, melanoma, ovarian, pancreatic, gall bladder, bladder, prostate, head and neck, and thyroid cancers. Circulogene is Clinical Laboratory Improvement Amendments (CLIA) certified and is continuing research initiatives to independently demonstrate greatly increased sensitivity and specificity compared to current methods. For more information, visit our website, connect with us on LinkedIn, email us at info@circulogene.com or call 855-614-7083. Headquartered in Birmingham, Ala., Circulogene is an innovative molecular diagnostics company founded and operated by a team of experienced industry executives and skilled molecular diagnostics scientists. Applying its proprietary laboratory developed test for cfDNA and cfRNA liquid biopsies, Circulogene has developed the first droplet-volume, next-generation sequencing (NGS) method to provide full genomic load analysis, enabling more accurate data to help clinicians and their patients. For more information, visit www.circulogene.com or call 855-614-7083.


News Article | May 12, 2017
Site: globenewswire.com

WALTHAM, Mass., May 12, 2017 (GLOBE NEWSWIRE) -- Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial results for its first quarter of 2017, ended March 31, 2017, and provided a corporate update. “We continued to advance our refined strategy that focuses on the potential utility of our Interleukin-1 (IL-1) genetic platform in the development of new classes of drugs for cardiac disease, and management of patients who have suffered previous cardiac events,” said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics. “We believe our proprietary genetic patterns have potential to accelerate clinical development through more targeted patient recruitment and may help address important questions such as dose responses, side-effect profiles and pricing/reimbursement strategies. Commercially, we believe our test may assist clinicians in identifying patients more likely to benefit from specific drug therapies. These scientific developments are potentially significant to the post-statin era of cardiovascular medicine, and in response to increased interest from potential partners, we have made our cardiovascular test program a major focus for the company. We are expanding efforts to build additional clinical evidence and are broadening business development outreach.” “We also continued to support our ILUSTRATM Inflammation Management Program by targeting ILUSTRA Program deployments and advancing new customer relationships that expand the evidence base for this program’s effectiveness,” said Mr. Carbeau. “These relationships will help demonstrate business impact and enable us to refine program elements for future deployments. We believe we add value by providing risk stratification, though engagement and empowerment, and by offering potential disease avoidance.” Total revenue was $196,000 for the three months ended March 31, 2017 compared to $961,000 for the three months ended March 31, 2016. The decrease in total revenue is primarily attributable to the absence of contracted research projects recognized in Other revenue for the three months ended March 31, 2017 compared to the same period in 2016. Genetic testing revenue also declined in the three months ended March 31, 2017 compared to the same period in 2016. Cost of revenue for the three months ended March 31, 2017, was $310,000, or 158% of total revenue, compared to $527,000, or 55% of total revenue, for the three months ended March 31, 2016. The increase in the cost of revenue as a percentage of revenue in the three months ended March 31, 2017 is primarily attributable to the fixed laboratory costs being applied to lower revenue in the period, which was due to less genetic tests processed and no contracted research projects. Research and development expenses were $425,000 for the three months ended March 31, 2017 compared to $480,000 for the three months ended March 31, 2016.  The decrease in research and development expenses was mainly due to decreased compensation expense and consulting costs. Selling, general and administrative expenses were $1.8 million for the three months ended March 31, 2017, compared to $1.3 million for the three months ended March 31, 2016.  The 35% increase is primarily attributable to increased compensation expense related to new staff in sales and marketing and higher consulting costs. The Company reported a net loss of $2,529,710, or ($0.01) per diluted share for the three months ended March 31, 2017, compared to a net loss of $1,517,736, or ($0.01) per share in the comparable period in 2016. As of March 31, 2017, the Company had cash of $791,000. On April 17, 2017, the Company completed a subordinated convertible note financing that raised gross proceeds of $1.0 million, and restructured its debt with Horizon Technology Finance Corporation to temporarily defer principal payments due under the loan. The Company expects that its current cash will be sufficient to support the Company’s operations through the second quarter of 2017. About Interleukin Genetics, Inc. Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic inflammatory diseases and health-related conditions, with significant expertise in metabolism and inflammation. Our tests provide information that is not otherwise available, to empower individuals and their healthcare providers to manage their health and wellness through genetics-based insights and actionable guidance, including pharmacogenomics information to guide development and use of therapeutics.  Interleukin Genetics’ lead products include our proprietary cardiovascular test to guide treatment of high risk patients; our proprietary ILUSTRA Inflammation Management Program; and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in suburban Boston and operates an on-site DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit www.ilgenetics.com. Forward-Looking Statements Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that the Company’s current cash will be sufficient to support the Company’s operations through the second quarter of 2017, and statements about our expected business focus and the expected benefits and potential of our products and potential products. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2016, and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.


News Article | May 9, 2017
Site: www.prnewswire.com

Total revenues were $46.9 million compared to $61.9 million for the first quarter of 2016, a decrease of 24%, driven primarily by Natera's transition to in-network contracts with payers, which reduced the average selling price of tests.  Tests processed were greater than 121,000 tests in the first quarter of 2017 compared to greater than 108,000 tests processed in the first quarter of 2016, including Constellation units, which represents an increase of approximately 12%.  Natera recognized revenue on greater than 62,000 tests in the current quarter.  51% of these tests were also accessioned in the first quarter of 2017. Natera recognized revenue on greater than 47,000 Panorama tests in the first quarter of 2017.  55% of these tests were accessioned in the first quarter of 2017. Gross profit for the three months ended March 31, 2017 was $13.2 million, representing a 28% gross margin, compared to $29.6 million, representing a 48% gross margin in the same period of the prior year.* Gross margins declined in the first quarter of 2017 compared to the same period of the prior year due to lower in-network pricing, one-time expenses related to the transition to Version 3 of Natera's Panorama test, and a one-time delay in revenue recognition due to a transition of volumes from the partner lab channel to Natera's direct sales channel. Excluding the one-time impacts from the transition to V3 and volumes to the direct sales channel, gross margin for the first quarter of 2017 would have been 7% higher. Total operating expenses, representing research and development expenses, and selling, general and administrative expenses, for the three months ended March 31, 2017 were $50.2 million, an increase of 28% compared to $39.2 million in the same period of the prior year. The increase in the three months ended March 31, 2017 over the prior period was driven primarily by an increase in personnel-related expenses associated with increase in research and development headcount, additional expenses related to Natera's sales and marketing efforts, and higher facility-related expenses as a result of the new lease negotiated for Natera's corporate headquarters in San Carlos, California. Loss from operations for the first quarter of 2017 was $37.0 million compared to loss from operations of $9.6 million for the same period of the prior year. Net loss for the three months ended March 31, 2017 was $36.0 million, or ($0.70) per diluted share, compared to net loss of $8.7 million, or ($0.17) per diluted share, for the same period in 2016. Weighted average diluted shares outstanding were 53.0 million for the first quarter of 2017. At March 31, 2017, Natera held $116.6 million in cash, cash equivalents, short-term investments and restricted cash, compared to $147.2 million as of December 31, 2016. As of March 31, 2017, Natera had an outstanding balance of $49.8 million with accrued interest under its $50.0 million line of credit with UBS at a variable interest rate of 30-day LIBOR plus 65 bps, compared to $49.6 million with accrued interest as of December 31, 2016, due to additional interest accrual of $0.2 million. The line is secured by Natera's investment portfolio, which is designed to yield higher returns than the borrowing rate Natera incurs in order to fund current operations. Natera anticipates 2017 total revenues of $210 million to $230 million; 2017 cost of product revenues to be approximately 60% to 65% of revenues; selling, general and administrative costs to be approximately $135 million to $140 million; research and development costs to be $45 million to $50 million, and net cash burn to be $65 million to $75 million**. This forecast improves Natera's previously provided financial outlook by reducing cash burn expectations by $10 million. Natera's research and development investments are intended to enhance its service offering and reduce the cost of goods sold of Panorama and Horizon, as well as technology development, product development, and clinical trials within oncology. Consistent with this guidance, Natera anticipates revenues and gross margins to increase, and cash burn to decrease, in the second quarter 2017 and through the remainder of 2017. * Gross profit is calculated as GAAP total revenues less GAAP cost of product revenues. Gross margin is calculated as gross profit divided by GAAP total revenues. ** Net cash burn is calculated as the sum of GAAP net cash used by operating activities (estimated for 2017 to be between $60 million and $70 million) and GAAP net purchases of property and equipment (estimated for 2017 to be approximately $5 million). Natera is a genetic testing company that develops and commercializes non-invasive methods for analyzing DNA. The mission of the company is to transform the diagnosis and management of genetic disease. In pursuit of that mission, Natera operates a CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, CA, and it currently offers a host of proprietary genetic testing services primarily to OB/GYN physicians and fertility centers, as well as to genetic laboratories through its cloud-based Constellation™ software platform. Product offerings include the Spectrum® pre-implantation genetic test for embryo selection during IVF; the Anora® miscarriage test to understand the genetic causes of a pregnancy loss; the Horizon™ carrier screen to detect inherited mutations; the Panorama® non-invasive prenatal test (NIPT) to screen for common chromosomal anomalies in a fetus as early as nine weeks of gestation; and Evercord™, a cord blood and tissue banking service offered at birth to expectant parents. Each test described has been developed and its performance characteristics determined by the CLIA-certified laboratory performing the test. These tests have not been cleared or approved by the U.S. Food and Drug Administration (FDA). Although FDA does not currently clear or approve laboratory-developed tests in the U.S., certification of the laboratory is required under CLIA to ensure the quality and validity of the tests. Natera is also applying its unique technologies to develop non-invasive screening and diagnostic tools for earlier detection and improved treatment of cancer. These tests have not been cleared or approved by the U.S. Food and Drug Administration. A webcast replay will be available at investor.natera.com. This release contains forward-looking statements, including statements regarding Natera's market opportunity, current and new products and services, commercial partners, user experience, clinical trials, future financial outlook and financial performance, strategies, and general business conditions. Any forward-looking statements contained in this release are based upon Natera's current plans, estimates, and expectations, as of the date of this release, and are not a representation that such plans, estimates, or expectations will be achieved. Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements in the future. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially, including: we face numerous uncertainties and challenges in achieving the financial guidance provided; we derive most of our revenues from Panorama, and if our efforts to further increase the use and adoption of Panorama or to develop new products and services in the future do not succeed, our business will be harmed; we have incurred losses since our inception and we anticipate that we will continue to incur losses for the foreseeable future; uncertainty in the development and commercialization of our enhanced or new tests or services, including future cancer products, could materially adversely affect our business, financial condition and results of operations; our quarterly results may fluctuate significantly; our estimates of market opportunity and forecasts of market growth may prove to be inaccurate, and even if the market in which we compete achieves the forecasted growth, our business could fail to grow at similar rates; we may be unable to compete successfully with either existing or future prenatal testing products or services; our cloud-based distribution model may be difficult to implement, and we may not be able to commercialize this model if we do not comply with ongoing regulatory requirements; implementation of our cloud-based distribution model may negatively impact our financial results and results of operations; we may be subject to increased compliance risks as a result of our rapid growth, including our recent growth in and dependence on our direct sales force; we rely on internal and third-party data centers and platforms to host our laboratory and cloud-based software, and any interruptions of service or failures may impair the operations of our laboratory or the delivery of our cloud-based software and harm our business; if our products do not perform as expected, our operating results, reputation and business will suffer; if we are unable to successfully grow revenues for our products or services in addition to Panorama, our business and result of operations may be adversely affected; the results of our clinical studies may not support the use of our tests, particularly in the average-risk pregnancy population or for microdeletions screening, or may not be able to be replicated in later studies required for regulatory approvals or clearances; we rely on a limited number of suppliers or, in some cases, single suppliers, for some of our laboratory instruments and materials and may not be able to find replacements or immediately transition to alternative suppliers; we may be unable to expand third-party payer coverage and reimbursement for Panorama and our other tests, or we may be required to refund reimbursements already received; and third-party payers may withdraw coverage or provide lower levels of reimbursements due to changing policies, billing complexities or other factors. Additional risks and uncertainties that could affect Natera's financial results are included under the captions, "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Natera's most recent annual report on Form 10-K. This is available on Natera's website at www.natera.com under the Investor Relations section and on the SEC's website at www.sec.gov. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/natera-reports-first-quarter-2017-financial-results-300454589.html


News Article | May 12, 2017
Site: globenewswire.com

WALTHAM, Mass., May 12, 2017 (GLOBE NEWSWIRE) -- Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial results for its first quarter of 2017, ended March 31, 2017, and provided a corporate update. “We continued to advance our refined strategy that focuses on the potential utility of our Interleukin-1 (IL-1) genetic platform in the development of new classes of drugs for cardiac disease, and management of patients who have suffered previous cardiac events,” said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics. “We believe our proprietary genetic patterns have potential to accelerate clinical development through more targeted patient recruitment and may help address important questions such as dose responses, side-effect profiles and pricing/reimbursement strategies. Commercially, we believe our test may assist clinicians in identifying patients more likely to benefit from specific drug therapies. These scientific developments are potentially significant to the post-statin era of cardiovascular medicine, and in response to increased interest from potential partners, we have made our cardiovascular test program a major focus for the company. We are expanding efforts to build additional clinical evidence and are broadening business development outreach.” “We also continued to support our ILUSTRATM Inflammation Management Program by targeting ILUSTRA Program deployments and advancing new customer relationships that expand the evidence base for this program’s effectiveness,” said Mr. Carbeau. “These relationships will help demonstrate business impact and enable us to refine program elements for future deployments. We believe we add value by providing risk stratification, though engagement and empowerment, and by offering potential disease avoidance.” Total revenue was $196,000 for the three months ended March 31, 2017 compared to $961,000 for the three months ended March 31, 2016. The decrease in total revenue is primarily attributable to the absence of contracted research projects recognized in Other revenue for the three months ended March 31, 2017 compared to the same period in 2016. Genetic testing revenue also declined in the three months ended March 31, 2017 compared to the same period in 2016. Cost of revenue for the three months ended March 31, 2017, was $310,000, or 158% of total revenue, compared to $527,000, or 55% of total revenue, for the three months ended March 31, 2016. The increase in the cost of revenue as a percentage of revenue in the three months ended March 31, 2017 is primarily attributable to the fixed laboratory costs being applied to lower revenue in the period, which was due to less genetic tests processed and no contracted research projects. Research and development expenses were $425,000 for the three months ended March 31, 2017 compared to $480,000 for the three months ended March 31, 2016.  The decrease in research and development expenses was mainly due to decreased compensation expense and consulting costs. Selling, general and administrative expenses were $1.8 million for the three months ended March 31, 2017, compared to $1.3 million for the three months ended March 31, 2016.  The 35% increase is primarily attributable to increased compensation expense related to new staff in sales and marketing and higher consulting costs. The Company reported a net loss of $2,529,710, or ($0.01) per diluted share for the three months ended March 31, 2017, compared to a net loss of $1,517,736, or ($0.01) per share in the comparable period in 2016. As of March 31, 2017, the Company had cash of $791,000. On April 17, 2017, the Company completed a subordinated convertible note financing that raised gross proceeds of $1.0 million, and restructured its debt with Horizon Technology Finance Corporation to temporarily defer principal payments due under the loan. The Company expects that its current cash will be sufficient to support the Company’s operations through the second quarter of 2017. About Interleukin Genetics, Inc. Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic inflammatory diseases and health-related conditions, with significant expertise in metabolism and inflammation. Our tests provide information that is not otherwise available, to empower individuals and their healthcare providers to manage their health and wellness through genetics-based insights and actionable guidance, including pharmacogenomics information to guide development and use of therapeutics.  Interleukin Genetics’ lead products include our proprietary cardiovascular test to guide treatment of high risk patients; our proprietary ILUSTRA Inflammation Management Program; and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in suburban Boston and operates an on-site DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit www.ilgenetics.com. Forward-Looking Statements Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that the Company’s current cash will be sufficient to support the Company’s operations through the second quarter of 2017, and statements about our expected business focus and the expected benefits and potential of our products and potential products. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2016, and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.


News Article | May 12, 2017
Site: globenewswire.com

WALTHAM, Mass., May 12, 2017 (GLOBE NEWSWIRE) -- Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial results for its first quarter of 2017, ended March 31, 2017, and provided a corporate update. “We continued to advance our refined strategy that focuses on the potential utility of our Interleukin-1 (IL-1) genetic platform in the development of new classes of drugs for cardiac disease, and management of patients who have suffered previous cardiac events,” said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics. “We believe our proprietary genetic patterns have potential to accelerate clinical development through more targeted patient recruitment and may help address important questions such as dose responses, side-effect profiles and pricing/reimbursement strategies. Commercially, we believe our test may assist clinicians in identifying patients more likely to benefit from specific drug therapies. These scientific developments are potentially significant to the post-statin era of cardiovascular medicine, and in response to increased interest from potential partners, we have made our cardiovascular test program a major focus for the company. We are expanding efforts to build additional clinical evidence and are broadening business development outreach.” “We also continued to support our ILUSTRATM Inflammation Management Program by targeting ILUSTRA Program deployments and advancing new customer relationships that expand the evidence base for this program’s effectiveness,” said Mr. Carbeau. “These relationships will help demonstrate business impact and enable us to refine program elements for future deployments. We believe we add value by providing risk stratification, though engagement and empowerment, and by offering potential disease avoidance.” Total revenue was $196,000 for the three months ended March 31, 2017 compared to $961,000 for the three months ended March 31, 2016. The decrease in total revenue is primarily attributable to the absence of contracted research projects recognized in Other revenue for the three months ended March 31, 2017 compared to the same period in 2016. Genetic testing revenue also declined in the three months ended March 31, 2017 compared to the same period in 2016. Cost of revenue for the three months ended March 31, 2017, was $310,000, or 158% of total revenue, compared to $527,000, or 55% of total revenue, for the three months ended March 31, 2016. The increase in the cost of revenue as a percentage of revenue in the three months ended March 31, 2017 is primarily attributable to the fixed laboratory costs being applied to lower revenue in the period, which was due to less genetic tests processed and no contracted research projects. Research and development expenses were $425,000 for the three months ended March 31, 2017 compared to $480,000 for the three months ended March 31, 2016.  The decrease in research and development expenses was mainly due to decreased compensation expense and consulting costs. Selling, general and administrative expenses were $1.8 million for the three months ended March 31, 2017, compared to $1.3 million for the three months ended March 31, 2016.  The 35% increase is primarily attributable to increased compensation expense related to new staff in sales and marketing and higher consulting costs. The Company reported a net loss of $2,529,710, or ($0.01) per diluted share for the three months ended March 31, 2017, compared to a net loss of $1,517,736, or ($0.01) per share in the comparable period in 2016. As of March 31, 2017, the Company had cash of $791,000. On April 17, 2017, the Company completed a subordinated convertible note financing that raised gross proceeds of $1.0 million, and restructured its debt with Horizon Technology Finance Corporation to temporarily defer principal payments due under the loan. The Company expects that its current cash will be sufficient to support the Company’s operations through the second quarter of 2017. About Interleukin Genetics, Inc. Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic inflammatory diseases and health-related conditions, with significant expertise in metabolism and inflammation. Our tests provide information that is not otherwise available, to empower individuals and their healthcare providers to manage their health and wellness through genetics-based insights and actionable guidance, including pharmacogenomics information to guide development and use of therapeutics.  Interleukin Genetics’ lead products include our proprietary cardiovascular test to guide treatment of high risk patients; our proprietary ILUSTRA Inflammation Management Program; and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in suburban Boston and operates an on-site DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit www.ilgenetics.com. Forward-Looking Statements Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that the Company’s current cash will be sufficient to support the Company’s operations through the second quarter of 2017, and statements about our expected business focus and the expected benefits and potential of our products and potential products. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2016, and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.


News Article | May 12, 2017
Site: globenewswire.com

WALTHAM, Mass., May 12, 2017 (GLOBE NEWSWIRE) -- Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial results for its first quarter of 2017, ended March 31, 2017, and provided a corporate update. “We continued to advance our refined strategy that focuses on the potential utility of our Interleukin-1 (IL-1) genetic platform in the development of new classes of drugs for cardiac disease, and management of patients who have suffered previous cardiac events,” said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics. “We believe our proprietary genetic patterns have potential to accelerate clinical development through more targeted patient recruitment and may help address important questions such as dose responses, side-effect profiles and pricing/reimbursement strategies. Commercially, we believe our test may assist clinicians in identifying patients more likely to benefit from specific drug therapies. These scientific developments are potentially significant to the post-statin era of cardiovascular medicine, and in response to increased interest from potential partners, we have made our cardiovascular test program a major focus for the company. We are expanding efforts to build additional clinical evidence and are broadening business development outreach.” “We also continued to support our ILUSTRATM Inflammation Management Program by targeting ILUSTRA Program deployments and advancing new customer relationships that expand the evidence base for this program’s effectiveness,” said Mr. Carbeau. “These relationships will help demonstrate business impact and enable us to refine program elements for future deployments. We believe we add value by providing risk stratification, though engagement and empowerment, and by offering potential disease avoidance.” Total revenue was $196,000 for the three months ended March 31, 2017 compared to $961,000 for the three months ended March 31, 2016. The decrease in total revenue is primarily attributable to the absence of contracted research projects recognized in Other revenue for the three months ended March 31, 2017 compared to the same period in 2016. Genetic testing revenue also declined in the three months ended March 31, 2017 compared to the same period in 2016. Cost of revenue for the three months ended March 31, 2017, was $310,000, or 158% of total revenue, compared to $527,000, or 55% of total revenue, for the three months ended March 31, 2016. The increase in the cost of revenue as a percentage of revenue in the three months ended March 31, 2017 is primarily attributable to the fixed laboratory costs being applied to lower revenue in the period, which was due to less genetic tests processed and no contracted research projects. Research and development expenses were $425,000 for the three months ended March 31, 2017 compared to $480,000 for the three months ended March 31, 2016.  The decrease in research and development expenses was mainly due to decreased compensation expense and consulting costs. Selling, general and administrative expenses were $1.8 million for the three months ended March 31, 2017, compared to $1.3 million for the three months ended March 31, 2016.  The 35% increase is primarily attributable to increased compensation expense related to new staff in sales and marketing and higher consulting costs. The Company reported a net loss of $2,529,710, or ($0.01) per diluted share for the three months ended March 31, 2017, compared to a net loss of $1,517,736, or ($0.01) per share in the comparable period in 2016. As of March 31, 2017, the Company had cash of $791,000. On April 17, 2017, the Company completed a subordinated convertible note financing that raised gross proceeds of $1.0 million, and restructured its debt with Horizon Technology Finance Corporation to temporarily defer principal payments due under the loan. The Company expects that its current cash will be sufficient to support the Company’s operations through the second quarter of 2017. About Interleukin Genetics, Inc. Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic inflammatory diseases and health-related conditions, with significant expertise in metabolism and inflammation. Our tests provide information that is not otherwise available, to empower individuals and their healthcare providers to manage their health and wellness through genetics-based insights and actionable guidance, including pharmacogenomics information to guide development and use of therapeutics.  Interleukin Genetics’ lead products include our proprietary cardiovascular test to guide treatment of high risk patients; our proprietary ILUSTRA Inflammation Management Program; and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in suburban Boston and operates an on-site DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit www.ilgenetics.com. Forward-Looking Statements Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that the Company’s current cash will be sufficient to support the Company’s operations through the second quarter of 2017, and statements about our expected business focus and the expected benefits and potential of our products and potential products. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2016, and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.


News Article | May 12, 2017
Site: globenewswire.com

WALTHAM, Mass., May 12, 2017 (GLOBE NEWSWIRE) -- Interleukin Genetics, Inc. (OTCQB:ILIU) today announced financial results for its first quarter of 2017, ended March 31, 2017, and provided a corporate update. “We continued to advance our refined strategy that focuses on the potential utility of our Interleukin-1 (IL-1) genetic platform in the development of new classes of drugs for cardiac disease, and management of patients who have suffered previous cardiac events,” said Mark B. Carbeau, Chief Executive Officer of Interleukin Genetics. “We believe our proprietary genetic patterns have potential to accelerate clinical development through more targeted patient recruitment and may help address important questions such as dose responses, side-effect profiles and pricing/reimbursement strategies. Commercially, we believe our test may assist clinicians in identifying patients more likely to benefit from specific drug therapies. These scientific developments are potentially significant to the post-statin era of cardiovascular medicine, and in response to increased interest from potential partners, we have made our cardiovascular test program a major focus for the company. We are expanding efforts to build additional clinical evidence and are broadening business development outreach.” “We also continued to support our ILUSTRATM Inflammation Management Program by targeting ILUSTRA Program deployments and advancing new customer relationships that expand the evidence base for this program’s effectiveness,” said Mr. Carbeau. “These relationships will help demonstrate business impact and enable us to refine program elements for future deployments. We believe we add value by providing risk stratification, though engagement and empowerment, and by offering potential disease avoidance.” Total revenue was $196,000 for the three months ended March 31, 2017 compared to $961,000 for the three months ended March 31, 2016. The decrease in total revenue is primarily attributable to the absence of contracted research projects recognized in Other revenue for the three months ended March 31, 2017 compared to the same period in 2016. Genetic testing revenue also declined in the three months ended March 31, 2017 compared to the same period in 2016. Cost of revenue for the three months ended March 31, 2017, was $310,000, or 158% of total revenue, compared to $527,000, or 55% of total revenue, for the three months ended March 31, 2016. The increase in the cost of revenue as a percentage of revenue in the three months ended March 31, 2017 is primarily attributable to the fixed laboratory costs being applied to lower revenue in the period, which was due to less genetic tests processed and no contracted research projects. Research and development expenses were $425,000 for the three months ended March 31, 2017 compared to $480,000 for the three months ended March 31, 2016.  The decrease in research and development expenses was mainly due to decreased compensation expense and consulting costs. Selling, general and administrative expenses were $1.8 million for the three months ended March 31, 2017, compared to $1.3 million for the three months ended March 31, 2016.  The 35% increase is primarily attributable to increased compensation expense related to new staff in sales and marketing and higher consulting costs. The Company reported a net loss of $2,529,710, or ($0.01) per diluted share for the three months ended March 31, 2017, compared to a net loss of $1,517,736, or ($0.01) per share in the comparable period in 2016. As of March 31, 2017, the Company had cash of $791,000. On April 17, 2017, the Company completed a subordinated convertible note financing that raised gross proceeds of $1.0 million, and restructured its debt with Horizon Technology Finance Corporation to temporarily defer principal payments due under the loan. The Company expects that its current cash will be sufficient to support the Company’s operations through the second quarter of 2017. About Interleukin Genetics, Inc. Interleukin Genetics, Inc. (OTCQB:ILIU) develops and markets proprietary genetic tests for chronic inflammatory diseases and health-related conditions, with significant expertise in metabolism and inflammation. Our tests provide information that is not otherwise available, to empower individuals and their healthcare providers to manage their health and wellness through genetics-based insights and actionable guidance, including pharmacogenomics information to guide development and use of therapeutics.  Interleukin Genetics’ lead products include our proprietary cardiovascular test to guide treatment of high risk patients; our proprietary ILUSTRA Inflammation Management Program; and its Inherent Health® line of genetic tests. Interleukin Genetics is headquartered in suburban Boston and operates an on-site DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit www.ilgenetics.com. Forward-Looking Statements Certain statements contained herein are “forward-looking” statements, including, but not limited to, statements that the Company’s current cash will be sufficient to support the Company’s operations through the second quarter of 2017, and statements about our expected business focus and the expected benefits and potential of our products and potential products. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Company’s annual report on Form 10-K for the year ended December 31, 2016, and other filings with the Securities and Exchange Commission. The Company disclaims any obligation or intention to update these forward-looking statements.


News Article | May 10, 2017
Site: www.businesswire.com

VANCOUVER, British Columbia--(BUSINESS WIRE)--Contextual Genomics Inc. (“Contextual”), developers of genomic cancer tests and computational systems, is pleased to announce it has received full accreditation from the Diagnostic Accreditation Program (DAP). Contextual is the first laboratory to receive full accreditation in Molecular Diagnostics from DAP. DAP, a program of the College of Physicians and Surgeons of British Columbia, assesses the quality of diagnostic services in the province. As part of the accreditation process, Contextual’s molecular testing and informatics systems were reviewed. Contextual is also accredited by the College of American Pathologists (CAP), and the Centres for Medicare and Medicaid Services (CMS) Clinical Laboratory Improvements Amendments (CLIA). Chris Wagner, President and CEO of Contextual, stated, “We are pleased to be the first company to receive full accreditation in Molecular Diagnostics from the DAP. This accreditation, along with our CAP/CLIA accreditation is a testament of our commitment to the highest quality, accuracy and safety. With our global expansion of molecular analysis services, it is extremely important to Contextual to set a gold standard in diagnostics and systems approaches.” Dr. David Huntsman, Chief Medical Officer of Contextual, commented “As molecular testing and bioinformatics analysis become more widely used in cancer diagnosis, high standards need to be set to ensure process quality and information accuracy. DAP’s rigorous review provides a great foundation for assuring patient safety as molecular testing develops in B.C.” In addition to the cost-effective molecular cancer tests developed by Contextual Genomics, the company has grown its ability to deploy its testing and analytics globally. Its bioinformatics services are designed to be utilized by partner laboratories around the world. The Find-It™ cancer panel is a multiplex, next-generation sequencing genomic assay designed for rapid deployment into labs around the world. Find-It™ evaluates the mutation status of tumor DNA at more than 100 well-characterized positions, identifying the somatic mutations that have the greatest potential to impact treatment decisions. QA Nexus™ is a quality control system embedded into all Find-It™ assays and into Contextual’s bioinformatic pipeline. About Contextual Genomics Contextual Genomics (www.contextualgenomics.com) has developed cost-effective and clinically actionable molecular tests that guide diagnosis and treatment of cancer. These customized tests are designed to be offered by partner laboratories around the world with Contextual conducting bioinformatics services via a SaaS model. The collection of data via this robust network of partners and the use of machine-learning tools will allow Contextual Genomics to improve patient care through improved clinical trial enrollment and new treatment algorithms. Contextual is managed by global leaders in cancer research and bioinformatics, who have unparalleled expertise in cancer genomics and the clonal evolution of cancer. This release contains forward-looking statements that are not based on historical fact. These forward-looking statements involve risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from those expressed or implied by such forward-looking statements. Readers are cautioned not to place undue reliance on such forward-looking statements.

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