Co-Diagnostics Inc (NASDAQ:CODX) (FRA:C97) revealed on Friday that its CLIA-certified customer Access Genetics LLC dba OralDNA Labs, which uses the company’s flagship Logix Smart COVID-19 kit, has received emergency use authorization (EUA) for its OraRisk COVID-19 RT-PCR test, allowing testing from a saline oral rinse collection.
This is the Food and Drug Administration’s (FDA) 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.
"We are pleased that Co-Diagnostics technology is being used in the first FDA EUA for a test using a simple saline 30-second swish and gargle collection,” Co-Diagnostics CEO Dwight Egan said in a statement.
“Because it eliminates the need for a nasal swab, oral rinse technology has the potential to dramatically improve comfort and accessibility of testing in our communities. We believe this authorization by the FDA provides additional confirmation of the quality, versatility, and adaptability of our CoPrimer platform," he added.
Co-Diagnostics’ Logix Smart COVID-19 test is currently available to all labs certified under Clinical Laboratory Improvement Amendments (CLIA) and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes the COVID-19 disease, in the US and many other countries. The company's Logix Smart test runs on its trademark CoPrimer technology and CoDx software.
The Utah-based company’s technology is utilized for tests that are designed using the detection and or analysis of nucleic acid molecules (DNA or RNA).
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