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Archives for June 2014

QIAGEN Receives FDA Approval of therascreen KRAS RGQ PCR Kit Paired with Second Colorectal Cancer Drug

QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) recently announced that its therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) has received U.S. Food and Drug Administration (FDA) approval to guide the treatment of metastatic colorectal cancer patients with Amgen’s Vectibix® (panitumumab). This marks the third FDA approval of a companion diagnostic from QIAGEN that has been paired with a novel medicine.

Immucor PreciseType HEA Test Becomes the First-Ever FDA-Approved Diagnostic for Molecular Typing of Donor and Recipient Red Blood Cells for Blood Transfusions

Immucor, Inc., a global leader in transfusion and transplantation diagnostics, announced that the U.S. Food and Drug Administration (FDA) has granted approval for the company’s PreciseType HEA test. The PreciseType HEA test is the first FDA-approved molecular assay designed to provide clinicians and blood banks with the detailed genetic matching information they need to reduce the risk of alloimmunization and serious hemolytic reactions, which is especially problematic for patients receiving frequent blood transfusions. These include people with genetic disorders, such as sickle cell disease, thalassemia, and patients with certain kinds of cancer.

Ventana Companion Diagnostics CAP/CLIA lab launches new Robust Prototype Assays

Ventana Medical Systems, Inc. (Ventana), a member of the Roche Group, recently announced the launch of three new companion diagnostic robust prototype assays (RPAs) for the detection of biomarkers PSMA, MDM2 and FGFR, offering biotech and pharmaceutical companies more options in exploring novel treatment options for patients with cancer. The new assays bring the company’s CAP/CLIA testing menu to almost 400, nearly 100 of which are RPA assays and the remainder are IVD approved Ventana tests.

Nicox and Sequenom Announce the Launch of Expanded Access to RetnaGene Test Portfolio in the U.S.

Nicox S.A. (NYSE Euronext Paris: COX), the international ophthalmic company, and Sequenom, Inc. (NASDAQ:SQNM), a life sciences company providing innovative genetic analysis solutions, recently announced that Nicox’s subsidiary, Nicox Inc. is launching expanded access to Sequenom Laboratories’ RetnaGene™ portfolio of laboratory-developed genetic tests in the United States (U.S.). The RetnaGene portfolio includes RetnaGene AMD and RetnaGene LR, specialized genetic tests, which assess an individual’s risk for advanced age-related macular degeneration (AMD).

DiscoveRx Announces Nature Biotechnology Publication of EPA ToxCast Data Validating BioMAP® Systems’ Ability to Predict Drug, Chemical Toxicities

Newly published research demonstrates the ability of BioMAP® Systems, a unique set of primary human cell and co-culture assays that model human disease and pathway biology, to identify important safety aspects of drugs and chemicals more efficiently and accurately than can be achieved by animal testing. Data from BioMAP Systems analysis of 776 environmental chemicals, including reference pharmaceuticals and failed drugs, on their ability to disrupt physiologically important human biological pathways were published recently in Nature Biotechnology. The results show that this in vitro approach can reproducibly identify potential toxicities and off-target drug effects, as well as pinpoint cellular mechanisms and specifically affected biomarker endpoints underlying specific types of adverse reactions in humans. DiscoveRx Corporation’s BioSeek division conducted the analysis in collaboration with scientists from the U.S. Food and Drug Administration, National Institutes of Health and U.S. Environmental Protection Agency as part of the EPA ToxCast Program.