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Coronavirus Test From DiaSorin Molecular Gets FDA Emergency Use Authorization

NEW YORK – An assay from DiaSorin Molecular to detect SARS-CoV-2, the virus that causes COVID-19, has been granted Emergency Use Authorization by the US Food and Drug Administration, the company said on Friday.

The test, called the Simplexa COVID-19 Direct assay, runs on DiaSorin's sample-to-answer Liason MDX real-time PCR instrument. It is intended to qualitatively detect nucleic acid from SARS-CoV-2 in nasopharyngeal swabs from individuals suspected of COVID-19 by their healthcare provider.

The Liason MDX can be used in two configurations. An eight-well direct amplification disc can be used for sample-to-answer testing, while a 96-well Universal Disc is designed for higher-volume testing. The discs require small volumes of sample and the instrument can perform both IVD as well as laboratory-developed tests.

Last week, DiaSorin was awarded $679,000 to further the development of its COVID-19 assay from US Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response's Biomedical Advanced Research and Development Authority, or BARDA, through its EZ-BAA process.

DiaSorin's test was granted EUA on Thursday, as was a test from GenMark. The list of COVID-19 tests with EUA now includes these as well as Roche, Thermo Fisher, Hologic, Quidel, and Abbott.