Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an Emergency Use Authorization for its OraRisk® COVID-19 RT-PCR test. This test is for qualitative detection of nucleic acid from SARS-CoV-2 in 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.
OralDNA® is a CLIA-certified and CAP accredited high-complexity laboratory. Testing involves extracting and purifying SARS-CoV-2 nucleic acid, which is then reverse transcribed into cDNA, followed by PCR amplification and detection using an authorized real-time PCR instrument.
“We are very pleased that our test has received FDA Emergency Use Authorization and that we are able to do our part during this pandemic,” said George Hoedeman, CEO of OralDNA® Labs. “The vast majority of our tests are resulted in less than 24 hours from receipt of sample, and well within our 1-2 business day turnaround time. We are serving the needs of healthcare professionals and patients across the US to help ensure essential services can be provided.”
- 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.