Simplexa COVID-19 Direct becomes second COVID diagnostic test cleared by FDA

After being backed by the Biomedical Advanced Research and Development Authority (BARDA) under public-private partnerships, the office recently announced that Simplexa COVID-19 Direct became the second standalone COVID-19 diagnostic cleared by the Food and Drug Administration (FDA).

In so doing, the FDA also made the DiaSorin Molecular LLC product its 64th approval, licensure and clearance. Simplexa is a real-time RT-PCR test allowing for amplification and detection of SARS-CoV-2 – the virus that causes COVID-19 – RNA from nasopharyngeal or nasal swabs without needing additional nucleic acid extraction. It targets two regions of the viral genome associated with SARS-CoV-2, minimizing the impact of mutations on test performance.

Meant for lab settings, it’s capable of producing results in approximately one hour, through use on the LIAISON MDC platform and direct amplification disc (DAD) – another product backed by BARDA. For Simplex, BARDA and DiaSorin worked together since March 2020 to develop, validate and acquire both Emergency Use Authorization (EUA) and, ultimately, full clearance from the FDA. Similarly, BARDA funded the LIAISON MDX platform 13 years ago as part of its flu preparedness efforts.

“For us, number 64 illustrates what government and industry can accomplish together,” BARDA said in a statement on Sept. 22. “With novel medicines, diagnostics, and vaccines we can save lives, protect the American people and enhance global health security.”

With the 64th approval, ongoing efforts at BARDA also represent 15 years of public and private partnerships focused on dealing with health security threats and building up medical countermeasures.