CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Oct. 15, 2020—OralDNA Labs announced that the FDA has issued an amended emergency use authorization for the OraRisk COVID-19 RT-PCR test, allowing testing from a saline oral rinse collection. The 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 having COVID-19 by their health care provider.
“Oral rinse collection will be a game-changer for COVID testing,” George Hoedeman, CEO of OralDNA Labs, said in a press release. “A 30-second convenient collection without a nasal swab will improve patient comfort, minimize exposure risk to frontline health care 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.”