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High-Risk Companion Diagnostics Need IDEs Prior To Drug Trial, FDA Says

 
• By Sue Darcey

Companies planning to co-develop an in vitro companion diagnostic alongside a therapeutic should be certain that the assay has been analytically validated and, if high risk, has won investigational device exemption before the drug trial begins, FDA warns in a July 14 draft guidance.

Before starting a clinical trial for a drug that will be paired with a companion in vitro diagnostic, sponsors must ensure that the diagnostic assay has undergone analytical validation and, if it’s a high-risk IVD, has earned an investigational device exemption (IDE) approval, the US FDA says in a new draft guidance on co-development of drugs and diagnostics.

The agency issued a guidance on the submissions and approval process for companion IVDs, defined as tests "providing information essential...

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• By Ashley Yeo

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NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 
• By Natasha Barrow

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