Shares of OraSure Technologies, Inc. (NASDAQ: OSUR) were advancing strongly Monday after the diagnostic company said its DNA Genotek subsidiary's saliva collection device used in COVID-19 testing has been approved for emergency use.
What Happened: Bethlehem, Pennsylvania-based OraSure said DNA Genotek's OMNIgene ORAL — a saliva collection and stabilization device — has been accorded emergency use authorization.
With this go-ahead from the FDA, OMNIgene ORAL devices can now be used for self-collection, transport and lab testing of saliva specimens suspected of containing SARS-CoV-2 RNA, OraSure said.
The device already has CE marking for in vitro diagnostic use, including for COVID-19 testing, in the European Union.
Related Link: The Week Ahead In Biotech: Spectrum Pharma FDA Decision, Biogen And Abbott Earnings, Cancer Conference
Why It's Important: The OMNIgene Oral collection device allows patients to safely collect their own sample, without the presence of a health care professional.
"Easy-to-use and reliable methods to detect SARS-CoV-2 are crucial to meet the massive need for testing which the Rockefeller Foundation estimates at 2.4 billion tests annually in the U.S. alone," said Stephen Tang, CEO of OraSure.
What's Next: With the use of the collection kits continuing to increase in back-to-work settings, back-to-school programs and lab testing, DNA Genotek said it has scaled up manufacturing of saliva collection devices to meet customer demand for COVID-19 testing. The company said it plans to significantly increase capacity in the first quarter of 2021.
The kit has been included in the emergency use authorizations for six customers.
OSUR Price Action: At last check, OraSure shares were jumping 18.25% to $16.33.
Related Link: COVID-19 Testing Stocks Move Lower After Abbott Receives EUA For 15-Minute Test
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October 19, 2020 at 09:55PM
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