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News Article | April 27, 2017
Site: globenewswire.com

GAITHERSBURG, Md., April 27, 2017 (GLOBE NEWSWIRE) -- OpGen, Inc. (NASDAQ:OPGN) today announced that Tina S. Nova, Ph.D. has been appointed to its Board of Directors.   Dr. Nova is a life science industry veteran with extensive experience building and leading novel genomics-based businesses. She currently serves as president and chief executive officer of Molecular Stethoscope, Inc., a newly formed molecular diagnostics company. Most recently, she was senior vice president and general manager of Illumina's oncology business unit. From 2000 to 2014, Dr. Nova was a co-founder and director, president and chief executive officer of Genoptix Medical Laboratory, which was purchased by Novartis Pharmaceuticals Corporation for nearly $0.5 billion in 2011. She has also held senior positions with Nanogen, Inc., Ligand Pharmaceuticals, Inc. and Hybritech, Inc. Dr. Nova currently serves on the board of directors for Arena Pharmaceuticals and Veracyte and is vice chairman of the board of directors for the newly formed Rady Pediatric Genomics and Systems Medicine Institute, which is part of Rady Children's Hospital-San Diego. Dr. Nova holds a B.S. degree in Biological Sciences from the University of California, Irvine where she graduated with honors and a Ph.D. in Biochemistry from the University of California, Riverside. “We are pleased to have Dr. Nova, a seasoned industry expert with a portfolio of high caliber successes, join the OpGen Board,” said Evan Jones, Chairman and CEO of OpGen. “Dr. Nova’s insights and experience from having built and advised successful molecular diagnostics companies will be invaluable as we continue to advance the development of our Acuitas Rapid Test and Acuitas Lighthouse Knowledgebase to combat the rise of multidrug-resistant organisms in our hospitals and health systems.” About OpGen OpGen, Inc. is harnessing the power of informatics and genomic analysis to provide complete solutions for patient, hospital and network-wide infection prevention and treatment. Learn more at www.opgen.com and follow OpGen on Twitter and LinkedIn.


Krishnan V.V.,California State University, Fresno | Krishnan V.V.,University of California at Davis | Krishnan V.V.,Genoptix Medical Laboratory | Ravindran R.,University of California at Davis | And 5 more authors.
Cytometry Part B - Clinical Cytometry | Year: 2014

Multiplex microbead immunoassay (MMIA) is a powerful technology for a wide range of biomedical and clinical applications. It is important to study the normal concentration ranges of immunomodulators under different sample preparation conditions and age groups of subjects in order to more precisely determine their reference values for use in assessing alterations of their levels in disease. The aim of this study was to determine the plasma concentrations of immunomodulators (cytokines, chemokines, and growth factors) in the peripheral blood from healthy subjects by the use of a large multiplex panel, and to determine the effects of different anticoagulants, age, and gender on the immunomodulator levels. In addition, the assay precision for these biomarker analytes was determined. Plasma samples from 107 healthy subjects, aged 18 to 85 years, were collected in three different anticoagulants (sodium citrate, EDTA, Heparin); corresponding serum samples were also obtained. Multiplex microbead immunoassays were performed for measuring a total of 23 analytes including chemokines, cytokines, and growth factors (IL-1β, IL-1ra, IL-2, IL-6, IL-7, IL-8, IL-12 p70, IL-17, IFN-γ, IP-10, MCP-1, PDGF-BB, RANTES, TNF-α, IL-1a, IL-16, HGF, MIG, TNF-β, PDGF-ABBB, EGF, Flt-3 Ligand, VEGF). For these analytes, our results showed that the anticoagulant affected the concentration measurements and the coefficients of variation. However, the relative levels of the analytes (profiles) of samples collected in a particular anticoagulant are consistent. The analytes IL-1β, IL-7, Flt-3 Ligand, and IL-12p70 show the largest variation (up to fourfold) between the age groups. In addition, no statistically significant differences in the level of the analytes were found between the sexes. © 2013 International Clinical Cytometry Society © 2014 Clinical Cytometry Society.


Ocean View, Delaware, Nov. 01, 2016 (GLOBE NEWSWIRE) -- Clinical Laboratory Services Market size was USD 196.9 billion in 2015, with 6.4% CAGR estimation from 2016 to 2024; as per a new research report by Global Market Insights, Inc. Growing importance of early diagnosis of chronic diseases related to oncology, gynaecology and endocrinology should drive global clinical laboratory services market size. Moreover, introduction of technologically advanced products rendering accurate and rapid results should spur industry growth over the forecast years. Request for a sample of this research report @ https://www.gminsights.com/request-sample/detail/807 Increased adoption of laboratory automations and robot assisted laboratory techniques such as TECAN liquid handling robotics will spur growth.  For instance, over 30% of laboratories in North America, Europe and Japan have implemented a significant degree of laboratory automation. Additionally, growing use of healthcare IT systems have enabled implementation of technologically advanced processes. Introduction of innovative solutions that allows implementation of informatics and data management systems to perform rapid and seamless operations with accurate clinical results with higher efficiency will accelerate industry growth. Chemistry segment held the largest clinical laboratory services market share with revenue slated to exceed USD 152 billion by 2024. Increasing prevalence of cardiovascular, diabetes, liver & kidney disorders coupled with growing awareness for early diagnosis will spur industry growth. U.S. held the largest share owing to high patient awareness and presence of large test volumes. APAC and LATAM will provide lucrative growth opportunities to industry players with introduction of regulatory standards to encourage the use of clinical laboratory services in these regions. Accounting for over one third of the global population, India and China are eyed upon as potential business hubs for clinical laboratory testing service providers. The key industry players include Quest Diagnostics, Sonic Healthcare, LabCorp, Genoptix Medical Laboratory, Healthscope, Labco, Charles River Laboratories and Bio-Reference Laboratories, Abbott Laboratories. The key strategies of mergers and acquisitions and strategic collaborations will enable industry players to strengthen their regional presence. Browse key industry insights spread across 110 pages with 33 market data tables & 10 figures & charts from the report, “Clinical Laboratory Services Market Size By Test (Human & Tumor Genetics, Clinical Chemistry, Medical Microbiology & Cytology, Other Esoteric Test), By Service Provider (Hospitals, Stand-Alone Laboratories, Clinics), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, Japan, China, Brazil, Mexico, South Africa), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2024” in detail along with the table of contents: Make an inquiry for purchasing this report @ https://www.gminsights.com/inquiry-before-buying/807 Clinical laboratory services market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD billion from 2012 to 2024 , for the following segments: The above information is provided on a regional and country basis for the following: Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider; offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.


News Article | November 16, 2016
Site: www.newsmaker.com.au

Clinical Laboratory Services Market size is estimated to reach USD 342.3 billion by 2024; as per a new research report by Global Market Insights, Inc. Growing importance of early diagnosis of chronic diseases related to oncology, gynaecology and endocrinology should drive global clinical laboratory services market size. Moreover, introduction of technologically advanced products rendering accurate and rapid results should spur industry growth over the forecast years. Increased adoption of laboratory automations and robot assisted laboratory techniques such as TECAN liquid handling robotics will spur growth.  For instance, over 30% of laboratories in North America, Europe and Japan have implemented a significant degree of laboratory automation. Additionally, growing use of healthcare IT systems have enabled implementation of technologically advanced processes. Request for a sample of this research report - https://www.gminsights.com/request-sample/detail/807 Introduction of innovative solutions that allows implementation of informatics and data management systems to perform rapid and seamless operations with accurate clinical results with higher efficiency will accelerate industry growth. Chemistry segment held the largest clinical laboratory services market share with revenue slated to exceed USD 152 billion by 2024. Increasing prevalence of cardiovascular, diabetes, liver & kidney disorders coupled with growing awareness for early diagnosis will spur industry growth. U.S. held the largest share owing to high patient awareness and presence of large test volumes. APAC and LATAM will provide lucrative growth opportunities to industry players with introduction of regulatory standards to encourage the use of clinical laboratory services in these regions. Accounting for over one third of the global population, India and China are eyed upon as potential business hubs for clinical laboratory testing service providers. The key industry players include Quest Diagnostics, Sonic Healthcare, LabCorp, Genoptix Medical Laboratory, Healthscope, Labco, Charles River Laboratories and Bio-Reference Laboratories, Abbott Laboratories. The key strategies of mergers and acquisitions and strategic collaborations will enable industry players to strengthen their regional presence. Browse key industry insights spread across 110 pages with 33 market data tables & 10 figures & charts from the report, “Clinical Laboratory Services Market Size By Test (Human & Tumor Genetics, Clinical Chemistry, Medical Microbiology & Cytology, Other Esoteric Test), By Service Provider (Hospitals, Stand-Alone Laboratories, Clinics), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, Japan, China, Brazil, Mexico, South Africa), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016 – 2024” in detail along with the table of contents: Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider; offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.


Bender R.P.,Caris Life science | McGinniss M.J.,Genoptix Medical Laboratory | Esmay P.,Caris Life science | Velazquez E.F.,Miraca Life science Research Institute | And 3 more authors.
Modern Pathology | Year: 2013

HRAS is mutated in ∼15% of Spitz nevi, and GNAQ or GNA11 is mutated in blue nevi (46-83% and ∼7% respectively). Epithelioid blue nevi and deep penetrating nevi show features of both blue nevi (intradermal location, pigmentation) and Spitz nevi (epithelioid morphology). Epithelioid blue nevi and deep penetrating nevi can also show overlapping features with melanoma, posing a diagnostic challenge. Although epithelioid blue nevi are considered blue nevic variants, no GNAQ or GNA11 mutations have been reported. Classification of deep penetrating nevi as blue nevic variants has also been proposed, however, no GNAQ or GNA11 mutations have been reported and none have been tested for HRAS mutations. To better characterize these tumors, we performed mutational analysis for GNAQ, GNA11, and HRAS, with blue nevi and Spitz nevi as controls. Within deep penetrating nevi, none demonstrated GNAQ or GNA11 mutations (0/38). However, 6% revealed HRAS mutation (2/32). Twenty percent of epithelioid blue nevi contained a GNAQ mutation (2/10), while none displayed GNA11 or HRAS mutation. Eighty-seven percent of blue nevi contained a GNAQ mutation (26/30), 4% a GNA11 mutation (1/28), and none an HRAS mutation. Within Spitz nevi, none demonstrated GNAQ or GNA11 mutations (0/30). Seventeen percent contained an HRAS mutation (5/30). All GNAQ and GNA11 mutations were p.Q209L (c.626A>T) point mutations, except 2 GNAQ mutations, which contained novel c.625-626CA>TT double mutations. Four HRAS mutations were in exon 2, and three in exon 3. This is the first study to identify HRAS mutations in deep penetrating nevi. The presence of HRAS mutations and absence of GNAQ or GNA11 mutations in deep penetrating nevi suggests classification of these unusual nevi within the Spitz nevus category of melanocytic tumors, rather than the blue nevus category. © 2013 USCAP, Inc. All rights reserved.


Kwok B.,Genoptix Medical Laboratory | Hall J.M.,Genoptix Medical Laboratory | Witte J.S.,University of California at San Francisco | Xu Y.,Genoptix Medical Laboratory | And 13 more authors.
Blood | Year: 2015

Establishing a diagnosis in patients suspected of having a myelodysplastic syndrome (MDS) can be challenging and could be informed by the identification of somaticmutations. We performed a prospective study to examine the frequency and types of mutations encountered in 144 patients with unexplained cytopenias. Based on bone marrow findings, 17% were diagnosed with MDS, 15% with idiopathic cytopenias of undetermined significance (ICUS) and some evidence of dysplasia, and 69% with ICUS and no dysplasia. Bone marrow DNA was sequenced for mutations in 22 frequently mutated myeloid malignancy genes.Somaticmutationswere identified in 71%ofMDSpatients, 62%ofpatients with ICUS and some dysplasia, and 20% of ICUS patients and no dysplasia. In total, 35% of ICUS patients carried a somatic mutation or chromosomal abnormality indicative of clonal hematopoiesis. We validated these results in a cohort of 91 lower-risk MDS and 249 ICUS cases identified over a 6-month interval. Mutations were found in 79% of those with MDS, in 45%of those with ICUS with dysplasia, and in 17% of those with ICUS without dysplasia. The spectrum of mutated genes was similar with the exception of SF3B1 which was rarely mutated in patients without dysplasia. Variant allele fractions were comparable between clonal ICUS (CCUS) and MDS as were mean age and blood counts. We demonstrate that CCUS is a more frequent diagnosis than MDS in cytopenic patients. Clinical and mutational features are similar in these groups andmay have diagnostic utility once outcomesinCCUSpatients are better understood. © 2015 by The American Society of Hematology.


Hastie B.A.,University of Florida | Riley III J.L.,University of Florida | Kaplan L.,Genoptix Medical Laboratory | Herrera D.G.,Centers for Disease Control and Prevention | And 6 more authors.
Pain | Year: 2012

Robust interindividual variation in pain sensitivity has been observed, and recent evidence suggests that some of the variability may be genetically mediated. Our previous data revealed significantly higher pressure pain thresholds among individuals possessing the minor G allele of the A118G SNP of the mu-opioid receptor gene (OPRM1) compared with those with 2 consensus alleles. Moreover, ethnic differences in pain sensitivity have been widely reported. Yet, little is known about the potential interactive associations of ethnicity and genotype with pain perception. This study aimed to identify ethnic differences in OPRM1 allelic associations with experimental pain responses. A total of 247 healthy young adults from three ethnic groups (81 African Americans; 79 non-white Hispanics; and 87 non-Hispanic whites) underwent multiple experimental pain modalities (thermal, pressure, ischemic, cold pressor). Few African Americans (7.4%) expressed the rare allele of OPRM1 compared to non-Hispanic whites and Hispanics (28.7% vs. 27.8%, respectively). Across the entire sample, OPRM1 genotype did not significantly affect pain sensitivity. However, analysis in each ethnic group separately revealed significant genotype effects for most pain modalities among non-Hispanic-whites (P <.05) but not Hispanics or African Americans. The G allele was associated with decreased pain sensitivity among whites only; a trend in the opposite direction emerged in Hispanics. The reasons for this dichotomy are unclear; they may involve ethnic differences in haplotypic structure, or A118G may be a tag-SNP linked to other functional polymorphisms. These findings demonstrate an ethnicity-dependent association of OPRM1 genotype with pain sensitivity. Additional research is warranted to uncover the mechanisms influencing these relationships. © 2012 International Association for the Study of Pain. Published by Elsevier B.V. All rights reserved.


PubMed | Genoptix Medical Laboratory, University of California at San Francisco and University of California at San Diego
Type: Journal Article | Journal: Blood | Year: 2015

Establishing a diagnosis in patients suspected of having a myelodysplastic syndrome (MDS) can be challenging and could be informed by the identification of somatic mutations. We performed a prospective study to examine the frequency and types of mutations encountered in 144 patients with unexplained cytopenias. Based on bone marrow findings, 17% were diagnosed with MDS, 15% with idiopathic cytopenias of undetermined significance (ICUS) and some evidence of dysplasia, and 69% with ICUS and no dysplasia. Bone marrow DNA was sequenced for mutations in 22 frequently mutated myeloid malignancy genes. Somatic mutations were identified in 71% of MDS patients, 62% of patients with ICUS and some dysplasia, and 20% of ICUS patients and no dysplasia. In total, 35% of ICUS patients carried a somatic mutation or chromosomal abnormality indicative of clonal hematopoiesis. We validated these results in a cohort of 91 lower-risk MDS and 249 ICUS cases identified over a 6-month interval. Mutations were found in 79% of those with MDS, in 45% of those with ICUS with dysplasia, and in 17% of those with ICUS without dysplasia. The spectrum of mutated genes was similar with the exception of SF3B1 which was rarely mutated in patients without dysplasia. Variant allele fractions were comparable between clonal ICUS (CCUS) and MDS as were mean age and blood counts. We demonstrate that CCUS is a more frequent diagnosis than MDS in cytopenic patients. Clinical and mutational features are similar in these groups and may have diagnostic utility once outcomes in CCUS patients are better understood.


Gustavson M.D.,Genoptix Medical Laboratory | Rimm D.L.,Yale University | Dolled-Filhart M.,Lincoln Laboratory
Personalized Medicine | Year: 2013

The use of tissue microarrays (TMAs) in the preclinical and translational research settings has become ubiquitous as they allow for high-throughput in situ biomarker analysis of hundreds of patient samples, with time and cost efficiency. Coupled with advanced imaging and image-analysis technologies that allow for objective and standardized biomarker expression assessment, TMAs have become critical tools for the development and validation of clinically meaningful biomarker diagnostic assays. However, their diagnostic use in the clinical laboratory setting is limited due to the need for conventional whole-section tissue assessment used for routine diagnostic purposes. In this article, after reviewing TMA basics and their translational and clinical research applications, we will focus on the use of TMAs for robust assay development and quality control in the clinical laboratory setting, as well as provide insights into how TMAs may serve well in the clinical setting as assay performance and quantification controls. © 2013 Future Medicine Ltd.


Barakat F.H.,University of Texas M. D. Anderson Cancer Center | Medeiros L.J.,University of Texas M. D. Anderson Cancer Center | Wei E.X.,Genoptix Medical Laboratory | Konoplev S.,University of Texas M. D. Anderson Cancer Center | And 2 more authors.
American Journal of Clinical Pathology | Year: 2011

Waldenström macroglobulinemia (WM) is currently defined as lymphoplasmacytic lymphoma involving bone marrow (BM) associated with a serum IgM paraprotein. WM is typically composed of small lymphocytes, plasmacytoid lymphocytes, and plasma cells in variable proportions, which can change after therapy. In this study, we assessed 41 WM cases that required chemotherapy, 39 showing persistent disease in restaging BM specimens. In 10 cases, there was persistent monotypic plasmacytosis in BM in the absence of demonstrable monotypic B cells. The monotypic plasma cells represented 0.5% to 46% of the cellularity and persisted 1 to 50 months after the last course of chemotherapy. The plasma cells were best quantified by immuno histochemical analysis on paraffin sections. We conclude that WM can persist as a pure plasma cell population after therapy. This finding has implications for the immunophenotypic assessment of WM after therapy and may explain persistent IgM paraproteinemia in patients with WM with no evidence of a clonal B-lymphocyte population. © American Society for Clinical Pathology.

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