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和FoundationOne®液体CDX，可以支持研究初创的监管方面，如研究风险测定（SRD）和调查设备豁免（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)
patient profiles in our Clinico-Genomic Database (CGDB)
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Important Safety Information
FoundationOne®CDx is a qualitative next-generation sequencing based体外晚期癌症患者的实体肿瘤诊断试验，仅供在处方使用。该试验分析324个基因以及基因组特征，包括微卫星不稳定性（MSI）和肿瘤突变负担（TMB），并且是鉴定可能根据经批准的治疗产品标记的特定疗法受益的患者的伴侣诊断。可以报告额外的基因组发现，并且不规定的或决定性用于标记使用任何特定的治疗产品。使用测试不保证患者将与治疗匹配。否定结果不会排除发生变化的存在。有些患者可能需要活组织检查。对于完整的标签，包括伴侣诊断指示和重要风险信息，请访问www.f1cdxlabel.com..
FoundationOne Liquid CDx
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based体外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 visitwww.F1LCDxLabel.com.