Co-Diagnostics Inc (NASDAQ:CODX) (FRA:C97) revealed on Wednesday that a company whitepaper demonstrates that its CoPrimer platform technology can be used to identify the presence of SARS-CoV-2 in human saliva samples without first requiring RNA extraction of the sample, and can do so while providing low limits of detection.
The Salt Lake City, Utah-based molecular diagnostics company said the technical advance featured in the whitepaper, was the result of a study into the compatibility of CoPrimer technology with detection of SARS-CoV-2 directly from raw saliva.
Various CoPrimer assay configurations were used to consistently detect SARS-CoV-2 in minimally processed saliva in the whitepaper, which concludes that “CoPrimers provide a robust platform for the development of such tests,” said the company.
In a statement, Co-Diagnostics CEO Dwight Egan said: "The market for high-throughput, cost-effective COVID-19 tests continues to be strong, and eliminating the costly and time-consuming RNA extraction step allows for even greater speed and economic advantages.”
He added: “We believe the conclusions of this whitepaper speak to the strength, innovation, and flexibility of our CoPrimer platform not just as it relates to creating improved testing technology for COVID-19, but also additional possibilities to implement CoPrimers in various other diagnostic applications.”
Egan said the company's next steps include incorporating “extraction-free saliva direct tests into the company product offerings, including those for COVID-19” so they can be available to its customer base worldwide.
The whitepaper follows news that Clinical Reference Laboratory (CRL) is now selling its CRL Rapid Response saliva-based COVID-19 RT-PCR test directly to consumers. The CRL tests use CoPrimer probes and primers developed by Co-Diagnostics with high degrees of sensitivity, and a simple saliva collection device gives results typically in 24 hours that are delivered through a secure online computer or mobile device platform.
"CRL has been an invaluable customer and partner in providing high-quality molecular diagnostic COVID-19 tests to individuals and organizations across the country, helping to facilitate the safe reopening of schools, business, and other organizations,” said Egan.
“We are pleased that its CRL Rapid Response test will now be even more widely available to consumers online," he added.
Co-Diagnostics' existing Logix Smart COVID-19 kit is available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19, in the US and many other countries. The company's Logix Smart test runs on its trademark CoPrimer technology and CoDx software.
Contact the author Uttara Choudhury at [email protected]
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