EDEN PRAIRIE, Minn., April 14, 2020 /PRNewswire/ -- OralDNA® Labs announces the availability of a PCR test for the novel coronavirus (SARS-CoV-2) under their OraRisk® line of salivary diagnostics. FDA has been notified of validation and an Emergency Use Authorization will be filed within 15 days as required by FDA guidance. As a CLIA-certified and CAP accredited high-complexity laboratory, OralDNA may use their validated test prior to EUA submission.
The OraRisk® – COVID-19 PCR test is based on the patented and EUA-authorized CoPrimer technology of Co-Diagnostics, Inc. RNA extraction for all specimen types is performed using the PerkinElmer Chemagic MSM I automated specimen processing system and analysis is performed on the Roche LightCycler® 480 II qPCR system.
Initial specimen collection kits which include a combination nasal swab and saline oral rinse are available in limited bulk quantities and single kits are expected to be available shortly (approx. 1-2 weeks). OralDNA® will also accept oropharyngeal swabs, nasopharyngeal swabs or nasal swabs in viral transport media or universal transport media.
"We will prioritize our testing to the areas of greatest need," said George Hoedeman, CEO of OralDNA® Labs. "After hospital needs are met, we believe front line and workplace testing will be critical to identify the disease before it spreads. We plan to work with first responders such as fire and police departments, and healthcare providers such as dentists to help provide safe environments for care. We wish to thank the University of Minnesota and the Minnesota Department of Health for their great assistance to us in our test development and validation."
About OralDNA Labs®
OralDNA® Labs is a specialty diagnostics company created by a team of dedicated healthcare and laboratory professionals. Our mission is to help create healthier patients. Good overall health starts with good oral health. OralDNA® Labs provides innovative diagnostic tests, exceptional customer support, and consultation to aid all healthcare professionals in detecting disease and risk factors at an earlier, more treatable stage. Tests include MyPerioPath® to identify 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.
SOURCE OralDNA Labs