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Multi-Companion Profiling Assay Enters FDA, CMS Express Lanes

The FoundationOne assay has been accepted into FDA's Expedited Access Pathway and the FDA/CMS Parallel Review program in an effort to advance what would be the first assay approved as a companion diagnostic for a range of tumor targets and drugs at once.

[Editor's note: Check out Medtech Insight's Expedited Access tracker for a running list of devices accepted into the EAP program.]

Foundation Medicine Inc. is taking advantage of two nascent US market pathways to benefit the development of what would be the first assay approved simultaneously as a companion diagnostic...

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