COVID-19 News

BARDA funds two more COVID-19 diagnostic tests

The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), has partnered with Austin, Texas-based Luminex Corporation and Carlsbad, California-based GenMark DX on COVID-19 diagnostic testing technologies.

BARDA is partnering with Luminex for the second time, this time on the development of a COVID-19 sample-to-answer diagnostic. The test detects the presence of COVID-19 in nasal and throat swabs and can be performed in community hospitals and other facilities with access to medium-complexity laboratories, greatly increasing the number of tests that can be run. BARDA will contribute approximately $642,000 of the total $1.7 million estimated project cost, and Luminex will fund the remaining development costs.

Luminex has designed an assay, which runs on its FDA-cleared ARIES® molecular diagnostic system, for the presence of COVID-19 by detecting the virus in respiratory swabs. The ARIES System is Luminex’s sample-to-answer, six-color, real-time polymerase chain reaction (PCR) instrument. ARIES assays require little training, take less than five minutes of hands-on time, and produce results in about two hours.

The Luminex solution consists of the ARIES® System and up to six cassettes. Each assay cassette contains all the reagents needed for nucleic acid extraction, amplification and detection for one sample. An operator adds the sample (in this case, a respiratory swab) to the cassette’s sample chamber, scans the sample ID and cassette, puts up to six cassettes in a magazine, and loads the magazine into the ARIES® System. The system starts automatically and reports results without further operator intervention. The Luminex ARIES® SARS-CoV-2 assay detects, via PCR, two SARS-CoV-2 targets within the “N” gene, for greater accuracy.

The first Luminex diagnostic to be supported by BARDA was the NxTAG® CoV Extended Panel, which received FDA Emergency Use Authorization on March 27, 2020.

BARDA is also 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 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.

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

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