BGI, Quidel launch COVID-19 diagnostics while HHS funds Mesa’s point-of-care test

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Industry is continuing to ramp up COVID-19 testing capacity to meet demand, as two diagnostics enter the U.S. market and HHS’s BARDA grants its fourth award for a COVID-19 assay.

BGI Genomics Co. Ltd. (SZSE:300676) launched its real-time fluorescent reverse transcriptase PCR (RT-PCR) COVID-19 diagnostic in the U.S. while it awaits an emergency use authorization (EUA) from FDA in the near future. To alleviate the shortage of COVID-19 diagnostics, FDA on Monday began to allow distribution and use of tests while manufacturers prepared EUA requests (see “FDA Expanding U.S. COVID-19 Test Capacity”).

FDA granted an EUA to the Lyra SARS-CoV-2 Assay from Quidel Corp. (NASDAQ:QDEL). The RT-PCR test detects SARS-CoV-2 genomic sequences from nasopharyngeal or oropharyngeal swabs. The company did not disclose which genes the assay detects.

HHS’s Biomedical Advanced Research and Development Authority (BARDA) granted $561,330 to Mesa Biotech Inc. to complete the necessary R&D on its Accula COVID-19 point-of-care test to apply for an EUA from FDA within two months of the award. HHS said the PCR-based diagnostic, which is the fourth COVID-19 assay to receive BARDA funding, has a 30-minute turnaround time.

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