Two key barriers to increased biomarker testing are insurance coverage and insufficient tissue1, and our portfolio can support your launch with the only FDA-approved portfolio of tissue or liquid biopsy CGP tests and national coverage for qualifying Medicare patients2
Access & Commercialization
Our Global Commercial Footprint is Ready to Support Your Needs
We continue to accelerate adoption and integration of our CGP testing around the world, with our tests available in more than 100 countries.
- We offer the only FDA-approved portfolio of complementary blood- and tissue-based comprehensive genomic profiling (CGP) tests, which can increase access to treatment, once approved, for patients with or without tissue available
- Our robust field teams across Commercial, Medical and Customer Experience functions work to maintain and grow our market leadership, represent our portfolio of tests and services, and cultivate relationships with healthcare providers and systems
- Our flexible solutions can accelerate the commercial launch of your new treatment, such as our service to provide timely, de-identified alerts on biomarker populations that can support your marketing and sales effectiveness
We offer a service that provides timely, de-identified alerts on biomarker populations to support your marketing and sales effectiveness
We can work together to co-develop biomarker education materials, coordinate plans for media communications and conferences, or create custom solutions to fit your needs
1. Schroll MM, Agarwal A et al. Stakeholders Perceptions of Barriers to Precision Medicine Adoption in the United States. J Pers Med. 2022 Jun 22;12(7):1025. doi: 10.3390/jpm12071025. PMID: 35887521; PMCID: PMC9316935.
2. Qualifying Medicare and Medicare Advantage members have coverage of FoundationOne CDx and FoundationOne Liquid CDx in accordance with the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) criteria
* Data on File, Foundation Medicine, Inc., 2022. Based on US settled claims from 1/1/21 to 3/31/22 for all CGP and IHC tests offered by Foundation Medicine and reported during that time before considering any financial assistance. 64% of commercially insured and 97% of Medicare and Medicare Advantage patients had a $0 financial responsibility for Foundation Medicine testing. Some patients may have higher financial responsibility
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.