FDA grants 510(k) clearance to GenMark’s new molecular diagnostics panel

12 June 2017 (Last Updated June 12th, 2017 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) clearance to market GenMark Diagnostics’ ePlex instrument and respiratory pathogen (RP) panel.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to market GenMark Diagnostics’ ePlex instrument and respiratory pathogen (RP) panel.

ePlex is an in-vitro diagnostic platform that combines a fully automated, sample-to-answer system with nucleic acid extraction, amplification and detection processes.

To enable quick and precise detection, the platform features the eSensor technology, which has been used on the firm’s XT-8 system for more than two million patient tests performed with various FDA-cleared panels.

The ePlex RP panel is designed to detect more than 20 viral and bacterial pathogens that are known to cause upper respiratory infections.

The combination of the RP panel with true sample-to-answer capabilities of ePlex is expected to allow quick, precise and actionable test results for high-risk patients, as well as enable improvement of productivity through decreased labour costs, advanced data analytics, customer service, and support.

"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."

GenMark president and CEO Hany Massarany said: “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.

“We believe that ePlex will help laboratories and hospitals realise 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.”

It is anticipated that the launch of ePlex will bolster the benefits of multiplex molecular testing and make them accessible to several hospitals and patients in the US.

GenMark has previously announced the signing of more than 70 ePlex customer agreements accounting to more than 100 analysers.