FDA Issues EUA for OraRisk® COVID-19 RT-PCR Test from OralDNA® Labs
EDEN PRAIRIE, Minn., July 21, 2020 /PRNewswire/ -- 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."
About OralDNA Labs®
SOURCE: OralDNA® Labs, a business of Access Genetics, LLC
View original content to download multimedia:http://www.prnewswire.com/news-releases/fda-issues-eua-for-orarisk-covid-19-rt-pcr-test-from-oraldna-labs-301096815.html
SOURCE OralDNA Labs