Co-Diagnostics Receives FDA Emergency Use Authorization for COVID-19 Test
By PR Newswire | 04.06.20
Company's technology targets the virus's RdRp gene.
Co-Diagnostics Inc., a molecular diagnostics company with a patented platform for the development of molecular diagnostic tests, announced today that its Logix Smart Coronavirus COVID-19 test has obtained Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2. The company's 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, and is available for purchase from the company's Utah-based ISO-13485:2016 certified facility.
Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs last month 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 Europe and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.
Co-Diagnostics CEO Dwight Egan said, "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. Many experts agree that accessibility of widespread testing is an important element to 'flattening the curve' as U.S. 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."
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. Co-Diagnostics believes the lower cost of reagents in the company's single-well test will help hospitals and laboratories to process more while paying less, benefiting healthcare providers and patients alike.
Co-Diagnostics began offering its COVID-19 test to some U.S. CLIA labs last month 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 Europe and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.
Co-Diagnostics CEO Dwight Egan said, "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. Many experts agree that accessibility of widespread testing is an important element to 'flattening the curve' as U.S. 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."
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. Co-Diagnostics believes the lower cost of reagents in the company's single-well test will help hospitals and laboratories to process more while paying less, benefiting healthcare providers and patients alike.
