NEW YORK – Co-Diagnostics said on Thursday its Logix Smart SARS-CoV-2 two-gene multiplex test has been approved in the UK.
The test has been validated according to regulations from the UK's Health Security Agency and can be sold in the UK, the Salt Lake City-based firm said, adding it has been validated for use with several sample types, including saliva. Additionally, bronchoalveolar lavage, sputum, tracheal aspirate, nasopharyngeal and oropharyngeal swabs can be used, according to the firm's website.
The RT-PCR-based test leverages Co-Diagnostics' CoPrimer technology to qualitatively detect the RdRp and E genes from the RNA of SARS-CoV-2.
Co-Diagnostics noted that the test is being offered in the UK by its distributor there, Client Life Science.
In June, Co-Diagnostics's Logix Smart SARS-CoV-2 DS test received CE marking.