GenMark Diagnostics Inc, Carlsbad, Calif, has received FDA premarket notification (510(k)) clearance for both its ePlex instrument and Respiratory Pathogen (RP) panel.
The ePlex diagnostic platform integrates nucleic acid extraction, amplification, and detection 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.
The ePlex RP panel detects more than 20 viral and bacterial pathogens that commonly cause upper respiratory infections. Combining the coverage of the ePlex RP panel with the sample-to-answer capabilities of 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, advanced data analytics, and best-in-class customer service and support.
“We are very pleased to announce the 510(k) clearance of ePlex and the Respiratory Pathogen panel,” says Hany Massarany, president and CEO of GenMark. “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.”
With FDA clearance achieved, ePlex installations at US customer sites are beginning, and revenue from these installations is expected to positively affect the company’s finances during the second half of 2017.
For more information, visit GenMark.