HILDEN, Germany, and GERMANTOWN, Maryland, — QIAGEN N.V. (NASDAQ: QGEN; Frankfurt Prime Standard: QIA) today announced it has received U.S. Food and Drug Administration (FDA) approval to market the therascreen® KRAS RGQ PCR Kit (therascreen KRAS test) to provide guidance on the use of Erbitux® (cetuximab) as a treatment in patients with metastatic colorectal cancer. […]

genXpress Service & Vertriebs GmbH started to distribute Anagnostics pharmacogenetics products in Austria with immedate effect. genXpress, based in Wr. Neudorf near Vienna, is a competent long term partner in Molecular Diagnostics for many laboratories in Austria. Anagnostics‘ hyborg and the hybcell tests perfectly complement the existing product portfolio offering complete solutions and innovative workflow […]

PLEASANTON, Calif., — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received premarket approval (PMA) from the U.S. Food and Drug Administration (FDA) for a new test to assess a patient’s viral load of cytomegalovirus (CMV). The fully automated COBAS® AmpliPrep / COBAS® TaqMan® CMV Test is the first FDA-approved laboratory test […]

Gaithersburg, Maryland and SEOUL, Korea, – Seegene Inc., (096530.KQ), a leading developer of multiplex molecular diagnostic technologies and tests, today announced that it will introduce Quantplex™ MTB/MDR/XDR Detection, a real time test that detects Mycobacterium tuberculosis and resistance mutations associated with multiple drug resistant (MDR) and extensively drug resistant (XDR) forms of M. tuberculosis at […]

Phenomenome Discoveries Inc. (“PDI”) and Polymedco Cancer Diagnostic Products LLC. (“Polymedco CDP”) are pleased to announce a commercial licensing agreement for the US market, providing rights to Polymedco to commercialize PDI’s diagnostic blood test that assesses an individual’s risk of colorectal cancer (“CRC”). Using patented technology, PDI has discovered that approximately nine out of ten […]

SAN DIEGO, — Sequenom, Inc. (NASDAQ: SQNM), a life sciences company providing innovative genetic analysis solutions, today announced the appointment of Carolyn Beaver to Vice President and Chief Accounting Officer. “Carolyn’s strong background and financial acumen make her an extremely valuable complement to the Sequenom management team,” said Paul Maier, Sequenom’s Chief Financial Officer. “We […]

INDIANAPOLIS, — Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today the launch in the U.S. and Canada of the cobas p 312 pre-analytical system, a front-end automation solution that offers comprehensive, vendor-neutral sample management for labs with limited floor space. The compact, stand-alone system performs sample registration, sorting, decapping and archiving of all sample tubes—including […]

ALISO VIEJO, Calif.– Ambry Genetics, a global leader in genetics with a focus on clinical diagnostics and genomic services, is sponsoring the Clinical Diagnostics Conference 2012, September 27-29 at the St. Regis Monarch Beach Resort. The event will feature a keynote speech by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World and author of The $1,000 […]

Mansfield, MA — PrimeraDx, a molecular diagnostics company, today announced that it has entered into a multi-year relationship with Eli Lilly and Company to develop diagnostic products in support of multiple clinical development programs for novel therapeutics. Under the terms of this agreement, the two companies will collaborate to develop innovative multiplex assays on PrimeraDx’s […]

LEXINGTON, Mass. AND MUNICH, Germany,– RainDance Technologies, Inc., the Digital Biology™ Company, today announced that MLL Munich Leukemia Laboratory (MLL) has purchased the company’s ThunderStorm™ System and consumables to process an initial 2,000 samples for use in the identification of prognostically relevant molecular mutations associated with Acute Myeloid Leukemia (AML) and other myeloid malignancies. Additionally, […]