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, we offer an FDA-approved companion diagnostic for all solid tumors. That means we can help streamline companion diagnostic (CDx) development by adding CDx claims to our analytically validated, comprehensive platform.
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.
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.
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
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.