Co-Diagnostics Inc (NASDAQ:CODX) announced Tuesday that its Logix Smart ABC (Influenza A/B, SARS-CoV-2) test and its Logix Smart SARS-CoV-2 multi-gene test were both awarded CE marks from European regulators, which allows the products to be sold as in-vitro diagnostics.
The Logix Smart ABC test kit is capable of simultaneous detection of and differentiation between influenza A, influenza B and SARS-CoV-2, the virus that causes COVID-19.
Due to the similarity in symptoms between the common cold, the flu and COVID-19, even vaccinated patients exhibiting any of these related symptoms will still require testing for differentiation, the company said. For that reason, Co-Diagnostics expects there to be a market for its ABC test even after a COVID-19 vaccine is widely available.
By comparison, Co-Diagnostic’s SARS-CoV-2 multi-gene test uses two gene markers, RdRp and E-gene, to identify the presence of SARS-CoV-2.
"Since announcing that we were the first American company to receive a CE marking for a COVID-19 diagnostic, Co-Diagnostics has continued to provide high-quality molecular diagnostic solutions for the coronavirus worldwide,” CEO Dwight Egan said in a statement. “We are pleased to now announce additional tools in the ongoing battle against the pandemic, especially for those regions where government or regulatory bodies recommend a multi-target coronavirus diagnostic, such as in India."
Both tests use the company's patented CoPrimer technology and are designed for use with saliva and other respiratory tract samples, such as nasal swabs or sputum. They are each available for purchase from the company's Utah-based certified facility.
"Our CoPrimer technology is ideally suited for multiplexed PCR tests, as it dramatically reduces the possibility of 'primer-dimers,' a common phenomenon in PCR reactions that leads to false-positive results, and allowing for assays with much higher specificity,” Egan said. “With up to 56 million flu cases in the US alone in the last flu season, and with symptoms that are often similar to those of COVID-19, we believe that the need for a high-quality diagnostic tool capable of accurately detecting and differentiating between flu A/B and COVID-19 while also delivering true-negative results will remain strong.”
The CE marks allow the export and sale of both tests as IVDs to begin immediately in Europe, as well as in other markets around the world that accept a CE mark as valid regulatory approval, following routine local product registration.
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