NEW YORK – DiaSorin Molecular said on Wednesday that it has received additional funding from the US Health and Human Services Biomedical Advanced Research and Development Authority to validate its Simplexa COVID-19 Direct kit and Simplexa COVID-19 & Flu A/B Direct kit.
The funding will also be used to submit the kits to the US Food and Drug Administration for 510(k) clearance. Both tests are for use with DiaSorin's Liaison MDX platform.
BARDA said the total BARDA contract is for about $4 million. In March, Cypress, California-based DiaSorin Molecular, a subsidiary of DiaSorin, received $679,000 in BARDA funding for the validation of the Simplexa COVID-19 Direct kit for Emergency Use Authorization from the FDA, which was issued later that month. Test results are provided in about one hour.
DiaSorin Molecular noted that the Simplexa COVID-19 Direct kit detects SARS-CoV-2 RNA, including in the new variants of the coronavirus recently isolated in the UK and South Africa.
The Simplexa COVID-19 & flu A/B Direct test provides results in about 90 minutes and is expected to be available for use during the 2021 influenza season
The two tests use a nasopharyngeal or nasal swab, or a bronchial lavage sample.