OraRisk Covid-19 RT-PCR test will use a saline oral rinse collection to detect SARS-CoV-2 nucleic acid, eliminating the need for a nasal swab
Ron McGlennen showing the OraRisk Covid-19 RT-PCR test. (Credit: OralDNA Labs.)
Access Genetics, doing business as OralDNA Labs, has received an amended US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its OraRisk Covid-19 RT-PCR test.
The new OraRisk Covid-19 RT-PCR test is designed to detect the presence of nucleic acid from SARS-CoV-2, the virus that causes Covid-19, using a saline oral rinse collection.
Using the saline oral rinse collection, the test would eliminate the need for a nasal swab and difficulty in providing sufficient saliva for saliva direct testing. The samples can be used for up to 72 hours and does not require transportation in refrigerated pack, said the company.
According to OralDNA Labs, its OraRisk Covid-19 RT-PCR test is the first simple saline 30 second swish and gargle collection test, to receive the emergency use authorisation from FDA.
OralDNA Labs CEO George Hoedeman said: “Oral rinse collection will be a game-changer for COVID testing. 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.”
OraRisk Covid-19 RT-PCR test detects nucleic acid from SARS-CoV-2
The test is intended for 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.
OralDNA Labs provides advanced diagnostic tests and consultation to help healthcare professionals detect disease and risk factors in early, and treatable stages.
The company’s tests include MyPerioPath to identify and measure harmful oral bacteria, Celsus One, to identify genetic inflammation risk, and OraRisk HPV to identify human papillomavirus related to oropharyngeal cancers and other oral diagnostics.
The OraRisk Covid-19 RT-PCR test was granted the EUA in July.