Co-Diagnostics Inc., a Salt Lake City-based molecular diagnostics company, has announced that that OralDNA Labs, a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, has validated a COVID-19 test based on the company’s CoPrimer technology for use with saline oral rinse samples and has notified the FDA of Co-Diagnostics’ intent to use the validated test in its CAP accredited high-complexity laboratory.
Dwight Egan, Co-Diagnostics CEO, said, “This validation on the OraRisk line of salivary diagnostics showcases the versatility and flexibility of our CoPrimer platform and COVID-19 test. 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.”
Co-Diagnostics’ Logix Smart COVID-19 test is currently available to all clinical laboratories certified under CLIA and is being used for the diagnosis of SARS-CoV-2, the virus that causes coronavirus.