DiaSorin Molecular announced that it has received additional federal funding from the Biomedical Advanced Research and Development Authority (BARDA) for the validation and submission of the Simplexa COVID-19 Direct kit and the Simplexa COVID-19 & Flu A/B Direct kit for 510(k) clearance from the U.S. Food and Drug Administration (FDA), according to a press release from the company.
DiaSorin Molecular initially received BARDA funding in March 2020 to test, validate and submit the Simplexa COVID-19 Direct kit for FDA emergency use authorization (EUA).
The Simplexa COVID-19 Direct kit detects the presence of the RNA of SARS-CoV-2, including the variants VUI 202012/01strain (lineage B.1.1.7) and the variant 20C/501Y.V2 (B.1.351 lineage), recently isolated in the United Kingdom and in South Africa respectively.
BARDA is a part of the Office of the Assistant Secretary for Preparedness and Response at the Department of Health and Human Services (HHS).
Simplexa COVID-19 Direct kit has been available in countries accepting CE Mark and in the United States through FDA EUA since the end of March 2020, and it is designed for use on more than 1,200 LIAISON MDX instruments installed worldwide.
The solution provides accurate results in around 1 hour, with a demonstrated clinical agreement of close to 100 percent against an established comparator.
Meanwhile, the Simplexa COVID-19 & Flu A/B Direct kit, for the simultaneous detection and differentiation of Influenza A, B, and SARS-CoV-2, is expected to be finalized and available for the 2021 influenza season.
