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FoundationOne Nabs US FDA Approval As Companion Diagnostic For Rare Cancers

 
• By Elizabeth Orr

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

Vials of liquid on a white table with the Roche logo in blue.
• Source: Shutterstock

A companion diagnostic’s new approval from the US Food and Drug Administration will give some oncology patients more clarity about whether a tumor-fighting drug is right for them.

Foundation Medicine, Inc. and its parent company Roche announced on 9 June that the FoundationOne CDx won regulatory approval for use as a companion diagnostic to Roche’s Rozlytrek...

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More from Policy & Regulation

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