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GenMark Diagnostics (GNMK) Receives FDA Clearance for RVP Test  
9/12/2012 8:01:19 AM

CARLSBAD, Calif.--(BUSINESS WIRE)-- GenMark Diagnostics, Inc., (GNMK) a leading provider of automated, multiplex molecular diagnostic testing systems, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (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 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.

Compared to other multiplex respiratory viral panels, the eSensor® RVP test delivers superior sensitivity and laboratory efficiency. With rapid processing and minimal hands-on time required from laboratory staff, GenMark’s 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.

“The FDA clearance of our eSensor® Respiratory Virus Panel test further demonstrates the capability of our uniquely differentiated electronic detection technology,” commented Hany Massarany, GenMark’s President and CEO. “The FDA review process, which was both collaborative and thorough, resulted in a 510(k) clearance which supports performance claims that we believe will meet customer needs and expectations, especially with regard to specificity, sensitivity and limits of detection,” Mr. Massarany continued.

About GenMark Diagnostics, Inc.

GenMark Diagnostics is a leading provider of automated, multiplex molecular diagnostic testing systems that detect and measure DNA and RNA targets to diagnose disease and optimize patient treatment. Utilizing GenMark’s proprietary eSensor® detection technology, GenMark's eSensor® XT-8 system is designed to support a broad range of molecular diagnostic tests with a compact, easy-to-use workstation and self-contained, disposable test cartridges. GenMark currently markets four tests that are FDA cleared for IVD use: Respiratory Viral Panel, Cystic Fibrosis Genotyping Test, Warfarin Sensitivity Test and Thrombophilia Risk Test. A number of other tests, including HCV Genotyping and 2C19 are in development. For more information, visit www.genmarkdx.com.

Safe Harbor Statement

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, but not limited to, those regarding our growth strategy, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, risks related to our history of operating losses, the need for further financing, inherent risk and uncertainty in the protection of intellectual property rights, and regulatory uncertainties regarding approval or clearance for our products, as well as other risks and uncertainties described under the "Risk Factors" in our public filings with the Securities and Exchange Commission. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

Contact:

GenMark Diagnostics, Inc.

Hany Massarany

Chief Executive Officer

760-448-4300


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