OralDNA Labs’s new test has been designed for the qualitative detection of nucleic acid from SARS-CoV-2
OralDNA Labs, a business of Access Genetics, has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its OraRisk Covid-19 RT-PCR test.
The new test has been designed for the 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.
The test includes the extraction and purification of SARS-CoV-2 nucleic acid
The test includes the extraction and purification of SARS-CoV-2 nucleic acid, Later, it will be reverse transcribed into cDNA, followed by PCR amplification and detection using an authorised real-time PCR instrument.
According to the company, the OraRisk Covid-19 RT-PCR test has not been FDA cleared or approved
OralDNA Labs CEO George Hoedeman said: “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.
“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.”
OralDNA Labs, which is a specialty diagnostics company, offers advanced diagnostic tests to help healthcare professionals detect disease and risk factors at an earlier and treatable stage.
The company offers MyPerioPath test to detect and measure harmful oral bacteria, Celsus One to identify genetic inflammation risk, OraRisk HPV to identify human papillomavirus-associated with oropharyngeal cancers and a variety of other oral diagnostics.
Earlier this month, Kroger Health secured FDA EUA status for its Covid-19 Test Home Collection Kit. Kroger’s test solution is said to combine the safety and convenience of at-home sample collection with the expert guidance of a telehealth consultation to help enhance the quality of the collection process.