FDA Clearance for True Sample-to-Answer Solution™ Respiratory Panel
GenMark Diagnostics, Inc. has received 510(k) market clearance from the FDA for both its ePlex® Instrument and Respiratory Pathogen Panel.
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.
“Rapid and accurate diagnosis of respiratory pathogens has been shown to improve outcomes in high risk patients and help hospitals address key priorities such as infection control and antimicrobial stewardship,” said Kimberle C. Chapin, M.D., Professor of Pathology and Medicine at Lifespan Academic Medical Centers and Brown Medical School. “We look forward to having GenMark’s ePlex technology because it is simple enough to be performed any time of day by multiple personnel and can be easily integrated into a patient care algorithm 24/7. It can provide fast, actionable results that will improve cohorting and patient flow through the ED, reduce unnecessary testing, and support appropriate antimicrobial use, particularly during the peak of respiratory season.”
“The Medical Center has relied on GenMark’s first-generation eSensor platform for syndromic infectious disease testing to help optimize patient treatment for the past several years,” noted Wallace H. Greene, PhD, D(ABMM), Director of Diagnostic Virology Laboratory at Penn State Health Milton S. Hershey Medical Center and one of the investigators in GenMark’s RP clinical study. “Our experience has shown that integrating this technology into a sample-to-answer platform like ePlex can further benefit patients with streamlined workflow and a high level of LIS integration to further accelerate the reporting of patient results.”
Tags: Respiratory Virus, Respiratory panel
Date Published: June 20, 2017
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