Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an amended Emergency Use Authorization for the OraRisk® COVID-19 RT-PCR test allowing testing from a saline oral rinse collection. This is the first Emergency Use Authorization for a simple saline 30-second swish and gargle collection. It 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,” said 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.
- This test has not been FDA cleared or approved;
- This test has been authorized by FDA under an EUA for use by Access Genetics, LLC dba OralDNA® Labs
- This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens
- This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in-vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.