OraSure Technologies, Inc.’s subsidiary DNA Genotek has received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the use of OMNIgene®·ORAL (OM-505, OME-505) device according to press release. The device, used in saliva collection and stabilization in COVID-19 testing, is the first FDA EUA that allows unsupervised in-home or healthcare setting testing.
- OMNIgene devices to be used for self-collection, transportation, and laboratory testing of saliva specimens containing suspected SARS-CoV-2 ribonucleic acid (RNA).
- DNA Genotek will scale up saliva collection devices’ manufacturing to meet demand and plans to increase capacity in Q1 2021.
- OMNIgene devices provide easy-to-use and reliable methods for detection of SARS-Cov-2 that meet massive needs of mass testing.
OraSure Technologies stock is gaining. OSUR: NASDAQ is up 23.82%