OraSure’s Rapid At-Home COVID-19 Test Receives Emergency Use Authorization From FDA

OraSure Technologies, Inc.’s DNA Genotek subsidiary has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for the use of DNA Genotek’s OMNIgene ORAL (OM-505, OME-505) saliva collection and stabilization device in coronavirus disease 2019 (COVID-19) testing. This is the first FDA EUA that allows for the unsupervised use of the device at-home or in a health care setting when used as part of an approved or validated at-home test kit, meaning individuals can safely collect their own sample, without the presence of a health care professional.

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