Download Literature - Companion Diagnostic Solutions

Universal Pan-Cancer CDx Platform

Foundation Medicine helps de-risk complex Companion Diagnostic (CDx) development utilizing our universal cancer CDx platform, reducing costs and shortening timelines associated with de novo CDx reagent and assay/kit development

Full Regulatory Support Services

Foundation Medicine helps you decide if an IDE is needed for your clinical trial and completes pre-submission and IDE filings.  We prepare all briefing and final submission documentation required by CDRH.  Foundation Medicine's Regulatory Affairs staff will be available in a supporting role for your interactions with CDER/CBER.

Post-Approval Support

Foundation Medicine provides integrated solultion support for Companion Diagnostic development.  Our platform contains the genes necessary to deploy nearly any cancer genomic biomarker.  Partners will not be dependent on a kit manufacturer's ability to establish a market for a new standalone diagnostic IVD and will benefit from the broad utilization of Foundation Medicine's diagnostic products from day one.

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