Co-Diagnostics, Inc Completes Successful Clinical Evaluation Required for FDA Emergency Use Authorization


Co-Diagnostics, Inc. , a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced that following a successful clinical evaluation of its Logix Smart™ COVID-19 Test, the Company will begin fulfilling orders from a wider array of U.S. customers, including thousands of additional laboratories in the country who can now run the Company’s test as a clinical diagnostic.

A recent FDA policy change aimed at expediting the availability of COVID-19 diagnostics has allowed the Company to expand domestic sales of its test immediately. Co-Diagnostics’ COVID-19 polymerase chain reaction (PCR) test can yield results in under two hours, and successfully passed the clinical evaluation as requested in the policy change, showing sensitivity of 100% and specificity of 100% in detecting SARS-CoV-2, the virus which causes COVID-19, without demonstrating any cross-reactivity with other coronaviruses.

Dwight Egan, Co-Diagnostics CEO, commented “Our Logix Smart COVID-19 test has already been deployed on a global basis to five continents as well as to U.S. CLIA labs that meet certain requirements, and we are prepared to provide an even greater number of U.S. laboratories and patients access to our test as a result of the new FDA policy. The demand for reliable, high-quality COVID-19 diagnostics has never been greater, and it continues to grow daily as this disease affects not just patients afflicted with it and their families, but the entire nation as a whole.

“We believe the excellent performance of our COVID-19 test combined with affordable pricing will place it in the vanguard of available testing alternatives worldwide. We have scaled up both our domestic and international production capabilities to meet demand, including receiving a license to manufacture our COVID-19 test in our facility in India, which more than triples our capacity. The Company’s Logix Smart COVID-19 test, built on our patented CoPrimer™ technology, has the potential to improve the quality of life of millions of Americans by providing access to a prompt, accurate, cost-effective test. We are gratified to be in a position to make available a test that can provide results in less than two hours, which we believe is among the fastest turn-around times of any test currently on the market.”

The new FDA policy permits Co-Diagnostics to begin U.S. sales of COVID-19 tests immediately while it awaits FDA clearance under Emergency Use Authorization (EUA). The Company’s application for EUA is currently under review by the FDA.