Diatherix-Eurofins’ SARS-CoV-2 test receives FDA emergency use authorization


HudsonAlpha resident associate company Diatherix-Eurofins announced that the Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its SARS-CoV-2 assay.

Click here to read the full announcement.

Diatherix has been at the forefront of SARS-CoV-2 testing, launching its highly sensitive and specific assay to thousands of existing and new clients on March 17, 2020. The CAP-accredited and CLIA-certified laboratory has capacity for up to 5,000 SARS-CoV-2 tests per day and offers clients one-day results.

Dr. Jeff Wisotzkey, chief science officer and lab manager for Diatherix, spoke with WAAY TV about how testing continues to be an important component in understanding the spread of COVID-19.

“The more people that we can test, the more that we can put together all of the information that we need to track the virus, to track the spread of the disease and know where it is and the impact that our social distancing and our other preventative measures are having,” he said.

Read the full story from WAAY TV.