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.
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“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.