BARDA Collaborates with GenMark Dx on a Rapid Diagnostic Test to Detect COVID-19

BARDA Response

BARDA is partnering with GenMark DX to develop an accurate, rapid coronavirus diagnostic for use in clinical and hospital labs. BARDA’s support follows a March 19 decision by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of the GenMark’s ePlex SARS-CoV-2 test to detect SARS-CoV-2 in samples collected from people suspected of being infected with COVID-19.

Development undertaken with BARDA support should allow the company to complete the necessary studies to request FDA clearance of the ePlex® Respiratory Pathogen v2 Panel to detect SARS-CoV-2 and other pathogens. This fifth BARDA-supported test increases domestic capacity in the current pandemic and any future outbreaks. Early, accurate diagnoses are essential to treating the infection and curbing the spread of disease.

BARDA will provide up to $749,000 of the total $1.4 million estimated development cost; GenMark will fund the remaining development costs.

This award is one component of BARDA’s rapidly expanding COVID-19 medical countermeasure portfolio; visit BARDA’s COVID-19 Portfolio to learn more.

About The Company:
The following information is provided by GenMark Diagnostics and does not indicate endorsement by the federal government of the company or its products.

GenMark Diagnostics is a leading provider of multiplex molecular diagnostic solutions designed to enhance patient care, improve key quality metrics, and reduce the total cost-of-care. Utilizing GenMark's proprietary eSensor® detection technology, GenMark's eSensor XT-8® and ePlex® systems are designed to support a broad range of molecular diagnostic tests with compact, easy-to-use workstations and self-contained, disposable test cartridges. GenMark’s ePlex: The True Sample-to-Answer Solution™ is designed to optimize laboratory efficiency and address a broad range of infectious disease testing needs, including respiratory, bloodstream, and gastrointestinal infections in a rapid, actionable timeframe.