As DiaSorin Molecular LLC works to create a combination diagnostic for differentiating between influenza A/B and COVID-19, it will receive funding, technical assistance, and the expertise of the Biomedical Advanced Research and Development Authority (BARDA).
The announcement, made this week, will bring government support to both this test and the Simplexa COVID-19 Direct assay, which has already been cleared by the U.S. Food and Drug Administration (FDA) for use under an emergency use authorization. Both tests use a nasopharyngeal, nasal swab, or bronchial lavage sample from patients to register results.
For diagnosis, the combo Simplexa COVID-19 & Flu A/B Direct assay will utilize DiaSorin’s LIAISON MDX, a diagnostic platform already used for flu and Respiratory Syncytial Virus (RSC) tests. It will be usable in both moderate and high complexity labs, including hospital labs, although it requires minimal input from operators. Turnaround for results should be approximately 90 minutes.
The additional funding will allow further studies needed to request full 510(k) clearance for both the COVID-19 and combination test kits that will allow them to move beyond emergency use and on to the market.