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Lab Validates Use of Co-Diagnostics's Covid-19 Test on Saliva Samples
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Lab Validates Use of Co-Diagnostics's Covid-19 Test on Saliva Samples

OralDNA labs notified FDA of its intent to use the validated test.

Co-Diagnostics could be moving toward a saliva-based COVID-19 PCR test in the future. This comes as OralDNA Labs, a Clinical Laboratory Improvement Amendments-certified laboratory, has validated a COVID-19 PCR test based on the Co-Diagnostics CoPrimer technology for use with saline oral rinse samples.

The Salt Lake City, UT-based company said OralDNA labs notified FDA of the intent to use the validated test.

“This validation on the OraRisk line of salivary diagnostics showcases the versatility and flexibility of our CoPrimer platform and COVID-19 test,” Dwight Egan, Co-Diagnostics said in a release. “Saliva specimens are easily collected with a simple swish and gargle, as opposed to more invasive collection methods such as nasal swabs. We are pleased that our technology is being deployed in so many areas in the United States and countries across the world, providing the type of quality, high-throughput diagnostic solutions that many experts agree is the most important step to curbing the spread of COVID-19 and saving lives."

Earlier this week, Rutgers RUCDR Infinite Biologics along with Spectrum Solutions and Accurate Diagnostics Labs (ADL) was granted the first emergency use authorization by FDA for a saliva-based COVID-19 test.

Co-Diagnostics has been on the front lines of testing for the virus in recent months. The company’s Logix Smart test is available to all clinical laboratories certified under CLIA and is authorized to be used for the diagnosis of SARS-Cov-2 the virus that causes COVID-19.

The company received CE mark for the test in February - during a time when there were 80,370 cases worldwide. Now there are about 2.1 million cases across the globe according to statistics from worldometer. About 137,000 people have died from the disease and 526,470 have recovered.

TAGS: IVD
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