Partnering with Biopharma
Working to Meet Your Needs and Challenges
Foundation Medicine is your dedicated partner to support your therapeutic development from discovery through to commercialization. Our innovations include proven comprehensive genomic profiling tests, genomic data solutions, clinical trial solutions, and companion diagnostic development/commercialization. We can help stratify patient cohorts, inform clinical trial design and drug development decisions, and increase patient access to potential investigational agents and trials.
Genomic Data Solutions
Our genomic information knowledgebase is continuously evolving, informed by every clinical sample sequenced with Foundation Medicine’s comprehensive genomic profiling tests. You can also access a unique clinicogenomic data set through our partnership with Flatiron Health, a leading provider of clinical data.
Clinical Trial Solutions
We help accelerate biomarker-driven clinical trials through better design, planning, and enrollment. We have a portfolio of assays available for use to enroll patients in clinical trials, including FDA-approved FoundationOne®CDx, and can support regulatory aspects of study start-up such as Study Risk Determinations (SRDs) and Investigational Device Exemptions (IDEs).
Companion Diagnostic (CDx) Development & Commercialization
Leveraging a proven portfolio and established platform may help: accelerate CDx development; mitigate development, regulatory, and commercial risk; and drive commercial adoption.
patients profiled (FoundationCore)
clinico-genomic profiles (CGDB)
Need More Details?
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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.