GenMark recieves 510(k) market clearance for ePlex instrument and RP Panel
GenMark announced that it has received 510(k) market clearance from the U.S. Food and Drug Administration for both its ePlex instrument and Respiratory Pathogen 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 established and proven 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 U.S. market is expected to enhance the benefits of multiplex molecular testing and make them accessible to many more hospitals and patients across the country. The ePlex RP Panel detects over 20 viral and bacterial pathogens that commonly cause upper respiratory infections. Combining the comprehensive coverage of the ePlex RP Panel with the true 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. The company previously announced it had secured over 70 ePlex customer agreements totaling more than 100 analyzers. With FDA clearance achieved, ePlex installations at U.S. customer sites are beginning and revenue from these installations is expected to positively impact 2H17. Accordingly, the company expects Q2 revenues in the range of $12M to $13M. For FY17, the company continues to expect revenue in the range of $65M-$70M and gross margin in the range of 48-52%. In connection with achieving FDA clearance for the ePlex instrument and RP Panel, the company intends to draw down an additional $15M under the terms of its existing debt facility.