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GenMark Gets 510(k) Clearance for ePlex Instrument, Respiratory Pathogen Panel

NEW YORK (GenomeWeb) – GenMark Diagnostics said today that it has received 510(k) clearance from the US Food and Drug Administration for its ePlex instrument and Respiratory Pathogen Panel, which detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections.

GenMark said that by combining broad pathogen coverage with ePlex's sample-to-answer capabilities, it provides physicians access to rapid, accurate, and actionable test results for high-risk patients. The instrument and panel "helps laboratory directors improve productivity through reduced labor costs, advanced data analytics, and best-in-class customer service and support," the firm added.

"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," GenMark President and CEO Hany Massarany said in a 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."

The ePlex instrument integrates nucleic acid extraction, amplification, and detection into a fully automated, sample-to-answer system. GenMark noted that the instrument's rapid and highly specific detection is enabled by the firm's established 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.

The introduction of ePlex to the US market is expected to make multiplex molecular testing accessible to many more hospitals and patients across the country, GenMark said.

In June 2016, GenMark received CE marking for the ePlex instrument and respiratory pathogen panel.

The firm said recently that it had already secured more than 70 ePlex customer agreements for more than 100 analyzers.

GenMark also noted that it expects revenues from ePlex installations at US customer sites to have a positive impact on its financial results for the second half of 2017. The firm said that it now expects second quarter 2017 revenues in the range of $12 million to $13 million. For full year 2017, it continues to expect revenues in the range of $65 million to $70 million.

The company added that it intends to draw down an additional $15 million under the terms of its existing debt facility, relating to achieving FDA clearance for the ePlex instrument and RP Panel.

In a note to investors today, Cowen analyst Doug Schenkel said that "after a long period of ePlex development, the story has now completely shifted to commercial execution." The investment bank expects "robust revenue growth" for GenMark, in the range of 40 to 50 percent for "the next several years," he added.