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Cancer IVDs Could See Label Expansions Under New Guidance

US FDA is proposing to allow cancer IVD-makers to label their tests for certain types of cancers and their therapies instead of limiting them to specific drugs and biologics. The agency says the expanded labeling is crucial to giving patients more options and help target treatments.

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If things go according to plan, more companion diagnostic developers will be able to market their tests to detect cancers that can be treated with a wider range of drugs and biologics. So far, such tests have typically been approved as companions to an individual treatment but a new draft guidance could change that by allowing them for therapeutic classes rather than specific treatments.

US FDA says the current standard for cancer drug/IVD pairings limit the kinds of treatments patients have access to and prevent patients from getting target treatments as part of the...

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