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GenMark’s IVD platform gets 510(k) clearance

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June 13, 2017GenMark Diagnostics has received 510(k) market clearance from the Food and Drug Administration for its ePlex instrument and its Respiratory Pathogen (RP) Panel.

Eplex is a new in vitro diagnostic platform that integrates nucleic acid extraction, amplification, and detection processes into a fully automated, sample-to-answer system. Rapid and highly specific detection is enabled on ePlex by GenMark’s eSensor technology, which has been used in more than two million patient tests conducted across multiple FDA-cleared panels on the company’s XT-8 system, according to a company statement.

The ePlex RP Panel detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections. Combining the ePlex RP Panel with the ePlex provides physicians access to rapid, accurate, and actionable test results for high-risk patients and helps laboratory directors improve productivity through reduced labor costs and advanced data analytics, according to the statement.

“We are very pleased to announce the 510(k) clearance of ePlex and the Respiratory Pathogen Panel. There is a growing body of evidence that rapid, multiplex molecular testing for respiratory pathogens improves patient outcomes, reduces total cost of care, and enhances key quality metrics,” Hany Massarany, GenMark’s president and chief executive officer, said in the statement. “We believe that ePlex will help laboratories and hospitals realize these benefits as it is the only sample-to-answer molecular platform that integrates the diagnostic process from test order entry, all the way to reporting actionable results.”

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