logo
Share SHARE
FONT-SIZE Plus   Neg

GenMark Secures FDA Clearance For Respiratory Virus Panel Test - Quick Facts

GenMark Diagnostics, Inc. (GNMK) said it obtained 510(k) clearance from the U.S. Food and Drug Administration, or FDA, for its eSensor Respiratory Virus Panel for use on its XT-8 system. This test is intended to simultaneously detect and differentiate 14 clinically relevant viruses from patients with influenza-like illness.

The company noted that the eSensor RVP test has the potential to significantly improve patient care by delivering superior co-infection detection, distinguishing Rhinovirus from Enteroviruses and identifying clinically relevant Adenoviruses.

According to GenMark, with rapid processing and minimal hands-on time required from laboratory staff, its eSensor RVP test enables clinical laboratories to rapidly report actionable patient results to physicians, while efficiently managing the fluctuating testing workload associated with this seasonal illness.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Toy maker Hasbro Inc. (HAS) reported a profit for the fourth-quarter 2015 that grew about 3.5% from last year. Quarterly net revenues increased 13% from the prior year. Both earnings per share and revenue for the quarter beat analysts' expectations. Healthcare plan provider Centene Corp. (CNC) has been executing on its strategic objectives, including margin expansion. With its growing portfolio of integrated health solutions, Centene has a strong presence in government-sponsored healthcare, the highest growth category in the industry. A California man has filed a lawsuit against McDonald's alleging that the fast food giant is defrauding customers by cramming its mozzarella sticks with filler instead of real cheese. Chris Howe is seeking at least $5 million in damages on behalf of consumers in 42 states and the District of Columbia. The...
comments powered by Disqus
Follow RTT