The test is not FDA approved, but is instead authorized for emergency use in the context of the SARS-CoV-2 pandemic.
The US Food and Drug Administration has issued an Emergency Use Authorization (EUA) for the OraRisk SARS-CoV-2 Reverse transcription polymerase chain reaction (RT-PCR) test.
The OraRisk test works by extracting and purifying nucleic acid from SARS-CoV-2 in respiratory samples collected in universal transport media and nasal swabs collected in oral saline rinse. The EUA was granted to OralDNA Labs, an accredited high-complexity laboratory.
"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,” said George Hoedeman, CEO of OralDNA Labs.
The test is not FDA approved, but is instead authorized for emergency use in the context of the SARS-CoV-2 pandemic. The test is only authorized for the duration of the declaration of a public health emergency.