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Roche Molecular Diagnostics

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Latest From Roche Molecular Diagnostics

FoundationOne Nabs US FDA Approval As Companion Diagnostic For Rare Cancers

The approval is the 25th indication for the diagnostic, but the first for any companion diagnostic to Roche’s Rozlytrek. 

Approvals Regulation

FDA: Roche Test Flaws Could Misdiagnose Patients With COVID-19, Flu

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.

Regulation Commercial

FDA To Lower Scrutiny Of CMV Tests Used In Transplant Patients

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.

Regulation Review Pathway

COVID-19 Registry Aims To Map And Address Potential Test Shortages

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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