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Companion Diagnostic Development & Commercialization

A Proven FDA-Approved Platform Supporting Accelerated Clinical Timelines

We collaborate seamlessly with our partners in biomarker-driven drug development — from biomarker discovery and refinement, through approval and commercialization. With FoundationOne®CDx and FoundationOne®Liquid CDx, we offer two FDA-approved companion diagnostics for all solid tumors. That means we can help streamline companion diagnostic (CDx) development by adding CDx claims to our analytically validated, comprehensive platform. 

Foundation Medicine’s globally established platform can help expedite CDx development, mitigate risk, and drive commercialization.

Lower Risks

Using our proven platform can help mitigate technical and commercial risks associated with companion diagnostics development by utilizing an established FDA-approved comprehensive profiling assay within our QSR-compliant laboratory.

Efficient Timelines

Our analytically validated and FDA-approved platform can potentially meet your program’s accelerated clinical development timelines. With our significant commercial footprint and ability to potentially add diagnostic claims through supplemental pre-market approval applications to the FDA, our platform is well suited to minimize ramp-up time for companion diagnostic development and commercialization of novel biomarkers.

End-to-End Support

Foundation Medicine provides integrated solution support for companion diagnostic development. Our platform contains the genes necessary to deploy nearly any cancer genomic biomarker from biomarker discovery through to commercialization. 

Important Safety Information

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FoundationOne CDx

FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Some patients may require a biopsy. For the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDxLabel.com.  

FoundationOne Liquid CDx

FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved therapeutic product labeling. Additional genomic findings may be reported and are not prescriptive or conclusive for labeled use of any specific therapeutic product. Use of the test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration.  Patients who are negative for companion diagnostic mutations should be reflexed to tumor tissue testing and mutation status confirmed using an FDA-approved tumor tissue test, if feasible.  For the complete label, including companion diagnostic indications and complete risk information, please visit  www.F1LCDxLabel.com.