HomeGenMark Diagnostics IncGenMark Receives FDA 510(k) Market Clearance for Its ePlex® Instrument and Respiratory Pathogen Panel

GenMark Receives FDA 510(k) Market Clearance for Its ePlex® Instrument and Respiratory Pathogen Panel

GenMark Diagnostics, Inc. (Nasdaq:GNMK), a provider of automated, multiplex molecular diagnostic testing systems, announced it has received 510(k) market clearance from the U.S. Food and Drug Administration for both its ePlex instrument and Respiratory Pathogen (RP) Panel.

ePlex is a transformational 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.

“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,” said Hany Massarany, President and Chief Executive Officer of GenMark. “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,” added Massarany.

“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.”

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 the second half of 2017. Accordingly, the Company expects second quarter 2017 revenues in the range of $12 to $13 million. For full year 2017, the Company continues to expect revenue in the range of $65 to $70 million 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 $15 million under the terms of its existing debt facility.

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Hinge Health Acquires the Most Advanced Computer Vision Technology for Tracking Human Motion

CEO Daniel Perez explained, “We won’t stop investing in technology to deliver the most patient-centered digital clinic that improves member experience and outcomes while reducing costs. wrnch allows us to take a giant leap forward in all respects.”

Dale W Wood Congratulates the Huma Team on Raising $130 Million

Major health and technology companies across the world have committed upwards of $130 million to Huma Therapeutics, the health-tech company backed by Dale Ventures.

Rhaeos Awarded $4 Million NIH SBIR Grant

Under the NIH SBIR grant, Rhaeos will leverage their existing wireless sensor hardware to provide additional quantitative flow data to the clinician, giving insight into this currently inaccessible and highly relevant shunt performance metric.

Gynesonics Announces FDA Clearance of Next Generation Sonata System

“This clearance brings significant system improvements that expand the location of fibroids that can be treated while allowing the physician to control all aspects of the treatment from within the sterile field,” said Jiayu Chen, Ph.D. Vice President, Engineering and Advanced Technologies at Gynesonics.

Blackrock Neurotech Invests In Groundbreaking Auditory Nerve Implant With University Of Minnesota And MED-EL

The new investment will enable the development and translation of a new ANI through preclinical studies and later, a pilot clinical trial, where the ANI is then implanted in up to three deaf patients.

Jonathan Chapman: New President/CEO of Trividia Health

Chapman said, “I’m honored to join the Trividia team as President and CEO. This organization has a long history of leadership within the healthcare industry as a provider of accurate, accessible, and affordable point-of-care solutions for the management of diabetes.”

SOLOPASS® System (Bedside Neuro-Navigation Device) Receives FDA 510(k) Clearance

inTRAvent’s SOLOPASS® system brings simple, portable, bedside neuro-navigation into the intensive care unit.

Skyhawk Therapeutics Completes New Investment Round

A $133 million round of investment will allow Skyhawk to accelerate development of its novel small molecule RNA-modifying drug candidates into the clinic.

By using this website you agree to accept Medical Device News Magazine Privacy Policy