Roche Molecular Diagnostics
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Latest From Roche Molecular Diagnostics
The approval is the 25th indication for the diagnostic, but the first for any companion diagnostic to Roche’s Rozlytrek.
The US agency has contacted health care providers to warn them about faulty COBAS SARS-CoV-2 and Influenza A/B Nucleic Acid Tests for use on the COBAS Liat System.
A proposed rule from the US agency would move the in vitro diagnostics from high-risk class III to class II with special controls, eliminating the requirement for a PMA.
Medtech industry group AdvaMed has developed a registry to share data on how many COVID-19 diagnostic tests are available and where they are, with a goal of foreseeing and nipping in the bud potential test shortages. Thirteen diagnostic manufacturers – including Abbott, Roche, Siemens and Thermo Fisher Scientific – have partnered with AdvaMed on the initiative.
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