DiaSorin Molecular COVID-19 test received FDA Emergency Use Authorization

March 31, 2020

DiaSorin Molecular has received Emergency Use Authorization (EUA) from the FDA for their Simplexa COVID-19 Direct kit. The kit provides a sample-to-answer test for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the virus that causes COVID-19, directly from nasopharyngeal swab specimens.

The Simplexa COVID-19 Direct kit is designed for use on the LIAISON MDX. It can be utilized by hospital laboratories without the need to send the sample out, allowing for timely testing and results. The kit contains an all-in-one reagent mix which is ready to use. Only one instrument and one reagent are required to perform the test. It bypasses the need for traditional extraction procedures, enabling rapid detection in a little over an hour, which is significantly faster than the seven hours currently required by traditional extraction followed by amplification technologies, ultimately allowing prompt decision making regarding isolation of infected patients.

The test is highly specific to COVID-19 and targets several regions of the viral genome to minimize the impact on performance should there be possible future mutations. This ensures the results are highly sensitive and specific providing confidence in diagnostic decision making.

DiaSorin Molecular received federal funds from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services, in order to develop this test. Because of the importance to increase the testing capacity at hospitals across the nation, this funding will accelerate the availability of diagnostic testing in order to help mitigate the potential impact of this virus.

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