DiaSorin Molecular announced that it received federal funding from BARDA for its Simplexa COVID-19 direct testing kit.
Cypress, Calif.-based DiaSorin’s undisclosed funding total received from the Biomedical Advanced Research and Development Authority (BARDA) is slated to support the validation and submission of the test for FDA 510(k) clearance and the ramp-up of manufacturing capacity for producing the test, according to a news release.
Simplexa is designed to detect the presence of RNA from SARS-CoV-2, the virus causing COVID-19. It has been available in countries accepting CE Mark approval and under emergency use authorization (EUA) in the U.S. since March 2020.
The test, which is meant for use on the Liaison MDX instruments, of which more than 1,200 are installed worldwide, which is mostly available in laboratories in the U.S.
DiaSorin’s test kit offers accurate results in around one hour and offers demonstrated specificity and sensitivity of 100%, the company said.
“The funding we received from BARDA to submit our COVID-19 molecular test for FDA 510(k) clearance is very important since it not only underlines our strong brand recognition in the U.S., but also acknowledges the quality of our product,” DiaDorin Molecular president John Gerace said in the release. “Moreover, we look forward to further expand our manufacturing capacity in the next months in order to address the significant demand we see in the market for our molecular test, an important diagnostic tool used by healthcare providers against the spread of COVID-19”.