Co-Diagnostics Receives CE Markings For Logix Smart ABC, SARS-CoV-2 Gene Multiplex Tests

(RTTNews) - Molecular diagnostics company Co-Diagnostics, Inc. (CODX) said Tuesday that its Logix Smart ABC (Influenza A/B, SARS-CoV-2) and its Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex tests for multiple targets of the SARS-CoV-2 genome have both obtained regulatory authorization to be sold as in-vitro diagnostics for the diagnosis of COVID-19 in markets that accept CE-markings.

The CE Markings for both the tests confirm that they meet the Essential Requirements of the European Community's In-Vitro Diagnostic Medical Device Directive, permitting export and sales of the products as IVDs to commence immediately in the European Community.

The company will also be able to sell the products in other global markets that accept a CE marking as valid regulatory approval.

The tests are now available for purchase from Co-Diagnostics' Utah-based ISO-13485:2016 certified facility.

Co-Diagnostics' Logix Smart ABC test kit allows for simultaneous detection of and differentiation between influenza A, influenza B, and SARS-CoV-2, the virus that causes COVID-19.

The company's SARS-CoV-2 multi-gene test uses two gene markers, RdRp and E-gene to identify the presence of SARS-CoV-2, and was designed to meet the demand for tests in regions that prefer multiple targets to confirm a positive diagnosis.

Both multiplex 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.

Co-Diagnostics noted that 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.

For this reason, the company believes a durable market will persist for its ABC test long after a COVID-19 vaccine is widely available. The test marks the company's entrance into the high-demand upper respiratory diagnostic space, independent of COVID-19.