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.
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.
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 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®Tracker is a clinical test performed exclusively as a laboratory service. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). FoundationOne Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. Treatment decisions are the responsibility of the treating physician. ctDNA detection sensitivity may be limited if blood collection occurs within two weeks of surgery or while a patient is on therapy. A negative test result does not definitively indicate the absence of cancer. This test is not designed to detect or report germline variation, nor does it infer hereditary cancer risk for a patient. This test is designed to detect ctDNA from the assayed tumor only; new primary tumors will not be detected. This test is expected to have limited sensitivity in some cancer types due to limited ctDNA shed.
FoundationOne Liquid CDX
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for 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. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who are negative for other 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.