Co-Diagnostics Inc (NASDAQ:CODX), a molecular diagnostics company, said Monday that its Logix Smart coronavirus (COVID-19) test has obtained Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to be used for the diagnosis of SARS-CoV-2.
In a statement, the company said its Logix Smart COVID-19 test can be used by clinical labs certified under Clinical Laboratory Improvement Amendments (CLIA) to detect the presence of the “virus that causes COVID-19,” and is available online to be bought from the company's ISO-13485:2016 certified facility in Utah.
In March, the company began marketing its Logix Smart COVID-19 test to a wide array of US laboratories without first requiring Emergency Use Authorization (EUA) from the FDA. This was in line with the FDA's policy for diagnostic tests for COVID-19 during the current public health emergency.
Co-Diagnostics is also the first US company to receive a CE-mark from the European Union (EU) for its coronavirus diagnostic test. Therefore, the company has initiated sales of its CE-IVD test to the EU, 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 he believed the authorization confirmed the “quality and performance” of the company’s coronavirus test kit, and that it is “a significant step in opening more doors” and helping the test to reach an even wider audience.
“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,” Egan said in a statement.
“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," he added.
The Co-Diagnostics Logix Smart COVID-19 test uses the company's patented CoPrimer technology to target the RdRp gene of the SARS-CoV-2 virus. The company said the “advanced nature of CoPrimers” 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 labs to “process more while paying less,” benefiting healthcare providers and patients alike.
The Salt Lake, Utah-based molecular diagnostics company’s technology 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.
The company is currently shipping orders for its test kits to 10 to 13 countries across five continents, including America, Europe, Asia and Australia.
Contact the author Uttara Choudhury at [email protected]
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