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MiRxes Receives CE Mark, Singapore Regulatory Approval for Multiplex SARS-CoV-2, Flu Test

NEW YORK – Singapore-based molecular diagnostic company MiRxes announced Monday it has received CE marking and Provisional Authorization from the Singapore Health Sciences Authority for its multiplex SARS-CoV-2 and influenza A/B test. 

The kit combines the real-time PCR Fortitude Kit SARS-CoV-2 test and syndromic panels for influenza A and B. It was jointly developed by Singapore's Agency for Science, Technology, and Research (A*STAR), Tan Tock Seng Hospital, and MiRxes. The company said in a statement it is currently applying for Emergency Use Authorization from the US Food and Drug Administration, as well as approval from Japan's Pharmaceuticals and Medical Devices Agency.

The original Fortitude test was developed by A*STAR and the hospital and licensed to MiRxes for production and distribution last February and can support 188 nasopharyngeal samples per kit. It has been deployed in 13 Singapore hospitals and labs and exported to more than 40 countries worldwide, the company said.

"Our assay for respiratory organisms is a panel designed to simultaneously detect an array of influenza viruses, with slots specifically reserved to rapidly incorporate a test for any emerging virus with epidemic or pandemic potential, as previously done for bird flu, swine flu, and MERS-CoV," Timothy Barkham, a senior consultant in the department of laboratory medicine at Tan Tock Seng Hospital, said in a statement. "The assimilation of SARS-CoV-2 into our influenza panel was a natural progression, planned for since inception."