FDA issues EUA for OralDNA's oral rinse COVID-19 test

By LabPulse.com staff writers

September 30, 2020 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for OraRisk, a saline oral rinse COVID-19 test from OralDNA Labs. OraRisk is a reverse transcription polymerase chain reaction (RT-PCR) test that is the first saline 30-second swish and gargle collection COVID-19 test to get an EUA.

The EUA gives OralDNA the authority to use the test specifically for the detection of nucleic acid from SARS-CoV-2.

OraRisk eliminates the need for a nasal swab and avoids the difficulty some people encounter in providing an adequate amount of saliva for direct SARS-CoV-2 testing. Samples are viable for up to 72 hours and do not require cold pack transportation.

Quadrant wins EUA for COVID-19 saliva test
Quadrant Biosciences has received emergency use authorization (EUA) from the U.S. Food and Drug Administration for its Clarifi COVID-19 test kit.
New CRISPR-based COVID-19 test shows high sensitivity
A new CRISPR-based test can produce results in 30 minutes to an hour, with similar accuracy as the standard polymerase chain reaction diagnostics now...
FDA spurs development of COVID-19 tests for use outside labs
The U.S. Food and Drug Administration (FDA) has published a template to help commercial companies develop COVID-19 molecular diagnostic and antigen tests...
FDA releases guidance on viral transport media for labs, manufacturers
The U.S. Food and Drug Administration (FDA) has issued guidance for clinical laboratories and commercial manufacturers on transport media for specimens...
OralDNA Labs launches PCR test for novel coronavirus
Dental testing specialist OralDNA Labs has rolled out a polymerase chain reaction (PCR) assay for SARS-CoV-2 from its OraRisk line of salivary diagnostics.

Copyright © 2020 LabPulse.com

Last Updated ls 9/30/2020 2:16:31 PM



Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Email
Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current