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FDA Issues EUA for Saline Oral Rinse COVID-19 RT-PCR Test from OralDNA® Labs

Published: Sep 30, 2020

 

EDEN PRAIRIE, Minn., Sept. 30, 2020 /PR Newswire/ -- Access Genetics, LLC dba OralDNA® Labs announces that FDA has issued an amended Emergency Use Authorization for the OraRisk® COVID-19 RT-PCR test allowing testing from a saline oral rinse collection. This is the first Emergency Use Authorization for a simple saline 30 second swish and gargle collection. It eliminates the need for a nasal swab and avoids the difficulty some individuals have in providing sufficient saliva for saliva direct testing. Samples are viable for up to 72 hours and no longer require cold pack transportation.

"Oral rinse collection will be a game-changer for COVID testing," said George Hoedeman, CEO of OralDNA® Labs. "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."

This test is for qualitative 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 by their healthcare provider.

  • This test has not been FDA cleared or approved;
  • This test has been authorized by FDA under an EUA for use by Access Genetics, LLC dba OralDNA® Labs
  • This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

About OralDNA Labs®
OralDNA® Labs is a CLIA-certified and CAP accredited high complexity laboratory created by a team of dedicated healthcare and laboratory professionals. Our mission is to help healthcare providers treat, heal, and inspire oral health through salivary diagnostics. 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.

Media Contact:  Amanda Seaton
855-ORALDNA (672-5362)
255596@email4pr.com 
http://www.oraldna.com

Related Links:
https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/vitro-diagnostics-euas#individual-molecular

http://www.oraldna.com

http://www.access-genetics.com

 

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SOURCE OralDNA Labs

  

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