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Access Genetics Nabs Amended FDA Emergency Use Authorization for Oral Rinse SARS-CoV-2 PCR Test

NEW YORK ─ Access Genetics, doing business as OralDNA Labs, said on Wednesday that the US Food and Drug Administration has issued an amended Emergency Use Authorization for its OraRisk COVID-19 RT-PCR test, allowing testing from the collection of a saline oral rinse.

The test enables the detection of nucleic acid from SARS-CoV-2 in saline oral rinse specimens, nasopharyngeal swabs, and nasal swabs collected in universal transport media, as well as nasal swabs collected in saline oral rinse from people suspected of COVID-19 by their healthcare provider.

Access Genetics' OraRisk COVID-19 RT-PCR test had received EUA in July to detect the RdRp gene of the virus in nasopharyngeal swab and nasal swab specimens using Co-Diagnostics' Logix Smart Coronavirus COVID-19 Test.

The new EUA is the first for use of a saline 30-second swish and gargle collection for SARS-CoV-2 testing, according to Eden Prairie, Minnesota-based OralDNA Labs. Samples are viable for up to 72 hours and don't require cold pack transportation.

George Hoedeman, CEO of OralDNA Labs, said in a statement that the collection method will "improve patient comfort, minimize exposure risk to frontline healthcare professionals, shorten collection time, and avoid supply-chain bottlenecks."