DiaSorin Molecular, Cypress, Calif, a subsidiary of DiaSorin SpA, has received additional federal funding from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services, for the validation and submission of the Simplexa Covid-19 Direct kit and the Simplexa Covid-19 & Flu A/B Direct kit for FDA 510(k) clearance. The company 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. The test 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 majority of which are installed in laboratories around the United States. DiaSorin Molecular has shipped over 1 million tests in the month of December 2020 alone.

The solution provides accurate results in around 1 hour, with a demonstrated clinical agreement of close to 100% against an established comparator. The rapid turn-around time allows for prompt decision-making in patient management, which is critical to help hospitals contain the pandemic and guide treatments.

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.

“The funding we received from BARDA will enable us to submit our Simplexa Covid-19 Direct and Simplexa Covid-19 & Flu A/B Direct kit molecular tests for FDA 510(k) clearance more rapidly,” says John Gerace, president of DiaSorin Molecular. “These products will allow for fast diagnosis of covid-19 and flu, which can be difficult to differentiate based on symptoms alone, and will be a critical component for guiding treatment decisions and managing patients in healthcare settings.”

For more information, visit DiaSorin Molecular