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Co-Diagnostics has obtained emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Logix Smart Coronavirus Covid-19 Test.
Clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) can now use the test to detect the presence of SARS-CoV-2, the virus, which causes Covid-19.
Using the company’s CoPrimer technology, the test will target the RdRp gene of the SARS-CoV-2 virus. It is run on a real-time RT-PCR kit that targets conserved regions in the virus genome.
Co-Diagnostics CEO Dwight Egan said: “We believe that this authorisation 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 US cases of Covid-19 continue to rise and that increased testing throughput is vital to achieving this objective.”
Following FDA’s policy for diagnostic tests for coronavirus during the current public health emergency, Co-Diagnostics began distributing the test to some US CLIA labs last month.
Earlier, the company started sales of its CE-IVD test to the European Community and to other global markets that accept a CE Mark as valid regulatory approval.
In February, Logix Smart Coronavirus COVID-19 Test secured CE Mark approval.
Additionally, Co-Diagnostics launched a research-use-only (RUO) CoPrimer test for coronavirus (2019-nCoV) during the same month. The test helps to detect the most optimal target on the 2019-nCoV genome for a PCR assay.