Access Genetics & OralDNA Labs announced today that it received FDA emergency use authorization (EUA) for its oral-rinse COVID-19 test.
Eden Prairie, Minn.-based Access’ OraRisk COVID-19 RT-PCR test allows for testing from a saline oral rinse collection.
Samples of the test are viable for up to 72 hours and don’t require cold pack transportation while they eliminate the need for nasal swabs or sufficient amounts of saliva in saliva-direct testing.
The test’s EUA is the first of its kind for a 30-second saline swish-and-gargle collection, according to a news release. It is only authorized for use in detecting nucleic acid from SARS-CoV-2 and not for any other viruses or pathogens.
“Oral rinse collection will be a game-changer for COVID testing,” OralDNA Labs CEO George Hoedeman said in the release. “A 30-second convenient collection without a nasal swab will improve patient comfort, minimize exposure risk to frontline healthcare professionals, shorten collection time, and avoid supply chain bottlenecks.
“These improvements, along with our exceptional turnaround times generally being shorter than our advertised 24 to 48 hours from sample receipt, will allow for an overall enhanced testing experience.”