In Vitro Diagnostics (IVD) News: Breaking In Vitro Diagnostics (IVD) News, Comments and Articles.

CML Healthcare Inc. and XDx, Inc. Announce Exclusive Licensing Agreement to Market and Distribute AlloMap® Heart Transplant Test

CML HealthCare Inc. (TSX: CLC) (the “Company” or “CML HealthCare”), a leading provider of medical diagnostic services in Canada, and XDx, Inc. (“XDx”), a leading U.S. molecular diagnostics company focused on high clinical impact blood tests for transplantation and autoimmune diseases, today entered into an exclusive licensing agreement that pro...

Biodesix Secures Medicare Coverage for VeriStrat® Test

Coverage of Predictive Biomarker Test Enables Lung Cancer Patients to Benefit From More-Informed Treatment Decisions Biodesix, Inc., a fully integrated molecular diagnostic company dedicated to personalizing medicine, today announced that Novitas Solutions, the Medicare Administrative Contractor for the region that includes Colorado, h...

Edison Investment - Stratec Biomedical - Weather update - Taken at the flood

Despite water ingress into a development area, plus some minor manufacturing damage last month, Stratec is expected to be financially back on course by the end of Q3 after some EBIT impact in Q2. Updated guidance for 2013 will be given with the Q2 results on 23 July. Hologics has won a contract for women’s health testing, which should boost US sales of the Panther in the medium term. Bio-R...

Luoxis Diagnostics, Inc. announces positive results from first clinical study conducted with company's proprietary diagnostic platform

GREENWOOD VILLAGE, Colo., June 20, 2013 /PRNewswire/ -- Ampio Pharmaceuticals (NYSE MKT: AMPE) today announced that majority-owned subsidiary Luoxis Diagnostics announced positive summary data from the first clinical trial using the company's oxidation-reduction potential (ORP) diagnostic system. The ORP system is a novel, patented point-of-care diagnostic platform measuring markers of oxidative s...

Boston Heart Diagnostics CEO Susan Hertzberg Named Ernst & Young Entrepreneur Of The Year® 2013 Finalist in New England

FRAMINGHAM, Mass., June 20, 2013 /PRNewswire/ -- Boston Heart Diagnostics, a pioneer in integrating next-generation diagnostics into personalized nutrition and lifestyle programs for patients with or at risk for heart disease, announced that a panel of independent judges has selected its President and CEO, Susan Hertzberg, as a finalist for the Ernst & Young Entrepreneur Of The Year 2013...

Can Herpes Affect Fertility? polyDNA Answers Survey Questions

In its June, 2013 survey, polyDNA found that 48% of male respondents were unaware of the fact that herpes sores on the scrotum do not affect fertility, but the herpes virus can harm fertility. polyDNA recommends Gene-Eden-VIR for men and their partners before they try to conceive. Rochester, NY (PRWEB) June 20, 2013 polyDNA’s latest monthly survey showed that respondents did not know that herpe...

Midwest Reproductive Symposium Showcases Latest Medical Advancements in Reproductive Endocrinology

Fertility Centers of Illinois hosts Chicago meeting June 20-22, 2013. Chicago, IL (PRWEB) June 20, 2013 The Midwest Reproductive Symposium, held June 20-22, 2013 in Chicago, IL. will draw top national and international leaders in the field of reproductive endocrinology. The symposium, hosted by Fertility Centers of Illinois, will discuss advancements, techniques, and treatment modalities relevant...

Skincare Devices Market is Expected to Reach USD 10.7 Billion Globally in 2018: Transparency Market Research

ALBANY, New York, June 20, 2013 /PRNewswire/ -- According to a new market report published by Transparency Market Research (http://www.transparencymarketresearch.com) "Skincare Devices Market (Lasabrasion, Microdermabrasion, Liposuction, LED Therapy, Dermatoscopes, Skin Rejuvenation, Cellulite Reduction, Skin Tightening & Body Contouring and Hair Removal) - Global Industry Analysis,...

Epitope Diagnostics Launches the First Commercially Available Immunoassay Kits Exclusively for the Quantitative Measurement of Antibody Drug Conjugate Level (ADC)

San Diego, CA, June 20, 2013 --(PR.com)-- Antibody-drug conjugates (ADCs) are a new type of targeted therapy which are very promising in cancer treatment, with the FDA approval of ADCETRIS® (brentuximab vedotin). ADCs are cancer cell specific monoclonal antibodies that are conjugated with highly potent cyotoxics via a specific linker, which delivers and releases the drug inside the tumor cel...

CML HealthCare Inc. and XDx, Inc. Announce Exclusive Licensing Agreement to Market and Distribute AlloMap(R) Heart Transplant Test

MISSISSAUGA, ONTARIO and BRISBANE, CALIFORNIA -- (Marketwired) -- 06/20/13 -- CML HealthCare Inc. (TSX: CLC) (the "Company" or "CML HealthCare"), a leading provider of medical diagnostic services in Canada, and XDx, Inc. ("XDx"), a leading U.S. molecular diagnostics company focused on high clinical impact blood tests for transplantation and autoimmune diseases, today entered into an exclusive li...

cGAS produces a 2′-5′-linked cyclic dinucleotide second messenger that activates STING

Detection of cytoplasmic DNA represents one of the most fundamental mechanisms of the innate immune system to sense the presence of microbial pathogens. Moreover, erroneous detection of endogenous DNA by the same sensing mechanisms has an important p...

LDL cholesterol blood levels: an interview with Dr. Harvey Kaufman

What is LDL cholesterol? What blood level of LDL cholesterol is considered optimal and why are high levels of LDL cholesterol a key marker of death risk from heart disease? Dr. Harvey Kaufman, senior medical director of Quest Diagnostics gives us som...

Public offering nets $64mm for [Exact Sciences]

Molecular diagnostics firm [Exact Sciences Corp.] netted $64mm through the public sale of 5.5mm common shares at $12.35.

Kelly Scientific Publications – announces the release of the publication “Personalized Medicine Market- A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment”.

Kelly Scientific Publications – a global leader of cutting-edge market intelligence announces the release of the publication “Personalized Medicine Market- A Strategic Analysis of Industry Trends, Technologies, Participants, and Environment”. This is a comprehensive account of the market size, segmentation, key players, SWOT analysis, influential technologies, and business a...

Amplion Research Launches Version 2.0 of BiomarkerBase™, the Database of Clinical Biomarkers, Significantly Expanding Its Ability to Inform Investments in Molecular Biomarkers and Personalized Medicine

BiomarkerBase™ 2.0 now includes every validated biomarker in clinical use, along with a significantly improved user interface and expanded functionality. The team at Amplion Research, publishers of BiomarkerBase™, manually reviewed every IVD test cleared or approved by the FDA since 2000, adding to the extensive set of test, drug, and clinical trial da...

LGC Genomics and Covaris, Inc. Announce FFPE DNA Extraction Partnership

WOBURN, Mass., June 19, 2013 /PRNewswire/ -- LGC Genomics and Covaris, Inc. announced they are partnering to develop an innovative solution for the high-throughput extraction of Nucleic Acids from Formalin-Fixed, Paraffin Embedded (FFPE) tissue samples. Covaris recently introduced a kit for high-yield DNA extraction from FFPE tissue samples.  Covaris' patented Adaptive Focused Acoustic™...

Mercy Lab Offers Faster On-demand Diabetes Testing, Cellular Studies

CANTON, Ohio, June 19, 2013 /PRNewswire/ -- Mercy Medical Center recently implemented advanced clinical laboratory diagnostics technology for conducting on-demand, Hemoglobin A1c (HbA1c) diabetes testing, as well as analysis of important red blood cell, white blood cell and platelet counts. The new system enables the hospital to provide faster, more accurate lab results for physicians and the...

Analysis Demonstrates Cost-Effectiveness Of Managing Low-Density Lipoprotein Particle Number To Reduce Cardiovascular Disease Risk

RALEIGH, N.C., June 19, 2013 /PRNewswire/ -- LipoScience, Inc. (NASDAQ: LPDX), a diagnostic company pioneering a new field of personalized nuclear magnetic resonance (NMR) diagnostics to advance the quality of patient care in cardiovascular, metabolic and other diseases, today announced the online publication of data in the Journal of Clinical Lipidology demonstrating the economic benefits of...

Express Diagnostics’ DrugCheck® On-site Test Cup Receives Health Canada Class III Medical Device Approval

Blue Earth, MN (PRWEB) June 19, 2013 Express Diagnostics Int’l, Inc., manufacturer of DrugCheck® on-site drugs of abuse tests, today announced that it has received Class III medical device license approval from Health Canada to market an...

STAT-Diagnostica Names Gérard Vaillant as Board Chairman

Medical diagnostics company STAT-Diagnostica has appointed Gérard Vaillant as chairman of the company’s board of directors. With more than three decades of senior leadership experience in the medical device and diagnostics sector, he brings expert industry perspective and guidance to the company as it prepares for the successive European and U.S. launch...

Qualyst Transporter Solutions and Kaly-Cell Announce the Transporter Certification™ of Human Cryopreserved Hepatocytes

RESEARCH TRIANGLE PARK, N.C., June 19, 2013 /PRNewswire-iReach/ -- Qualyst Transporter Solutions, LLC, has completed its Transporter Certified™ process on two high-quality, plateable cryopreserved human hepatocytes from Kaly-Cell.  The Transporter Certified™ process uses the patented B-CLEAR® technology to assess hepatocytes for uptake and efflux transporter function, endogen...

Gold Standard Diagnostics’ Next-Generation Lyme Disease Testing Becoming Widely Accepted Amongst Clinical Laboratories

Achieve Accurate, Reproducible Results with FDA Cleared Borrelia burgdorferi B31 Confirmation Blots Gold Standard Diagnostics, Corp. (GSD, www.gsdx.us), a leading manufacturer and marketer of clinical laboratory instrumentation and assays for the in vitro diagnostics market, announces new Line Immunoassay technology for

Beckman Coulter Announces FDA Clearance of New Access AccuTnI+3 Troponin I Assay for the Access 2 Immunoassay System

BREA, Calif., June 19, 2013 /PRNewswire/ -- Continuing its long history of proven clinical performance in diagnosis of myocardial infarction (MI), Beckman Coulter, Inc. announces the U.S. Food and Drug Administration (FDA) 510(k) clearance of its new Access AccuTnI+3 troponin I assay for use on its Access 2 immunoassay system. "Clinicians have depended on Beckman Coulter's troponin I test f...

Glycotope Has Completed Randomization of Phase II Clinical Trial with Glycooptimized and Fully Human FSH-GEX(TM) for In Vitro Fertilization

Glycotope GmbH / Glycotope Has Completed Randomization of Phase II Clinical Trial with Glycooptimized and Fully Human FSH-GEX(TM) for In Vitro Fertilization . Processed and transmitted by Thomson Reuters ONE. The issuer is solely responsible for the content of this announcement. Berlin, Germany, June 19th, 2013 - Glycotope GmbH, a global leader in optimizing the glycosylation of biopharmaceutica...

Pharma IQ Presents the Latest Trends in Clinical Trial Supply

NEW YORK, June 19, 2013 /PRNewswire/ -- Pharma IQ is pleased to announce the release of a brand new infographic summary of the results from an industry survey conducted earlier this year. Nearly a third of all respondents stated that CROs would be an area of active investment in the next 6 months. 50% of respondents will be running 6 or more clinical trials in the BRIC region. The infographic, c...