Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, announced today that a recent Company whitepaper demonstrates that the 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 technical advance featured in the whitepaper, found here, 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.

Dwight Egan, CEO of Co-Diagnostics, commented, "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. 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. Our 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 our customer base world-wide."

Release of the Company whitepaper follows recent 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 announcement states that the test uses CoPrimer probes and primers developed by Co-Diagnostics with high degrees of sensitivity and specificity, and a simple saliva collection device that can be administered in virtually any setting, with results in typically 24 hours that are delivered via a secure online computer or mobile device platform.

Mr. Egan continued, "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. We are pleased that its CRL Rapid Response test will now be even more widely available to consumers online."

Co-Diagnostics' existing CE-marked and FDA EUA Logix Smart COVID-19 test 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.