OralDNA Labs

Oct 15, 2020

FDA EUA for Saline Oral Rinse Covid-19 RT-PCR Test The OraRisk Covid-19 RT-PCR test, which allows testing from a saline oral rinse collection, has received an amended FDA emergency use authorization (EUA). The test, from OralDNA Labs, Eden Prairie, Minn, is the first EUA for a simple saline 30 second swish-and-gargle collection. The test eliminates the need for a nasal swab and avoids the difficulty some individuals have in providing sufficient saliva for saliva direct testing. Samples are viable for up to 72 hours and no longer require cold pack transportation. “Oral rinse collection will be a game-changer for covid testing,” says George Hoedeman, CEO of OralDNA Labs. “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.” This test is for qualitative detection of nucleic acid from SARS-CoV-2 in oral saline rinse specimens, nasopharyngeal swab and nasal swab specimens collected in universal transport media, and nasal swabs collected in oral saline rinse, from individuals suspected of covid-19 by their healthcare provider. Share: