Co-Diagnostics Receives FDA EUA for Logix Smart Coronavirus COVID-19 Test

Co-Diagnostics, Inc. (Salt Lake City, UT, USA), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, has obtained Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) for its Logix Smart Coronavirus COVID-19 Test to be used for the diagnosis of SARS-CoV-2.

Co-Diagnostics develops, manufactures and markets a new, state-of-the-art diagnostics technology which is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.

The Co-Diagnostics Logix Smart Coronavirus COVID-19 Test uses the company's patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus. The advanced nature of CoPrimers has allowed Co-Diagnostics to design a highly-specific, single-well PCR test, allowing higher throughput over tests that require multiple wells. The company believes the lower cost of reagents in its single-well test will help hospitals and laboratories to process more while paying less, benefiting healthcare providers and patients alike.

Following the granting of EUA by the FDA, the COVID-19 test can be used by clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the virus that causes COVID-19. Co-Diagnostics had begun offering its COVID-19 test to some US CLIA labs in March as a result of the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency. Previously, the company had initiated sales of its CE-IVD test to the European community, and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

“We believe that this authorization confirms the quality and performance of our COVID-19 test, and that it is a significant step in opening more doors and helping this test to reach an even wider audience,” said CEO of Co-Diagnostics Dwight Egan. “Many experts agree that accessibility of widespread testing is an important element to 'flattening the curve' as US cases of COVID-19 continue to rise, and that increased testing throughput is vital to achieve this objective. We look forward to continuing our goal of increasing the availability of advanced, high-throughput, and cost-effective COVID-19 testing solutions both close to home and across the globe.”

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