OraSure device receives emergency use authorization from the FDA: Corrected

Doctors will soon have another test in their arsenal to fight the COVID-19 pandemic.

Bethlehem’s OraSure has gotten the approval it needs for its saliva-based sample collection device.

According to a press release, OraSure’s DNA Genotek subsidiary received Emergency Use Authorization from the U.S. Food and Drug Administration for the use of DNA Genotek’s OMNIgene ORAL (OM-505, OME-505) saliva collection and stabilization device in COVID-19 testing.

The company noted that this is the first FDA emergency-use authorization that allows for the unsupervised use of a device when used as part of an approved or validated at-home test kit, meaning patients can safely collect their own sample, without the presence of a healthcare professional.

The test can be used in the home or in a health care setting.

“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 S. Tang, OraSure president and CEO.