Foundation Medicine NGS testing has broad coverage to make market access easier
Our solutions with extensive coverage and support services can facilitate market access and adoption for testing to identify patients for your approved therapy
Biomarker Testing Access & Commercialization
Our flexible solutions can accelerate the commercial launch and adoption of your new treatment by increasing access to NGS tests and offering global market reach and commercial launch support
Access to NGS testing
Increase access to patients for your approved therapy through our NGS testing and broad coverage, with nearly 9 of 10 patients owing $01
Global Market Reach
Access key markets around the world through our established commercial and medical teams and Roche affiliates
Custom Commercial Launch Support
Create a custom partnership with our solutions that can accelerate the commercial launch of your therapy
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Comprehensive Actionable Testing
- Tissue and blood-based NGS tests allowing access to patients that can benefit from your new therapy.
Broad Coverage
- Broad insurance coverage, including Medicare, means more patients can access our tests – and nearly 9 out of 10 patients owe $0 for testing1.
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Financial Assistance
- Assistance is available for qualifying patients who have out-of-pocket costs. Those who qualify will pay no more than $100 per test.
Additional Support
- FoundationAccess® is a service to walk patients through the entire coverage and billing process
- We partner with Glidian to submit prior authorizations to health plans and reduce burden on healthcare staff.
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Increase your global market reach by leveraging our commercial footprint
Foundation Medicine has established global reach and expertise across regions with experienced commercial and medical teams and Roche affiliates
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United States
- Over 40+ FDA approved CDx indications2
- Established channels to key oncology stakeholders including academic medical centers, VA, and community networks
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European Union
- Continued Comprehensive Genomic Profiling (CGP) volume growth in key markets in 2023
- First tech transfer announced in France with Institute Gustave Roussy (IGR)
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Japan
- Dedicated Chugai team in Japan supporting two MHLW-approved tests with 40+ CDx indications2
- Greater than 90% market share of CGP testing in Japan3
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Accelerate the commercial launch of your therapy
Foundation Medicine can support your commercial launch through our CGP alerts or custom partnership agreements, featuring internal training to marketing and field support
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FoundationReachTM for Commercial
- Provides timely insights for effective healthcare provider (HCP) engagement after biomarker results
- Reaching providers quickly after biomarker results can address the “actionability gap” between interpretation and treatment planning
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Testing Education and Promotional Resources
- Customized internal training on NGS testing for your medical or commercial field teams
- Co-development of educational or promotional plans to amplify the launch of a new CDx indication and therapy combination
We can help you with your therapy development from initial discovery through regulatory approval and commercialization
Learn more about how we can help you with:
1. Data on File, Foundation Medicine, Inc., 2023. Based on US settled claims for FoundationOne®CDx, FoundationOne®Liquid CDx, FoundationOne®Heme, and PD-L1 IHC ordered from Foundation Medicine, reported between 1/1/22 and 3/31/23 before considering any financial assistance. 65% of commercially insured and 96% of Medicare and Medicare Advantage patients owe $0 for Foundation Medicine testing.
2. Data on File, Foundation Medicine, Inc., 2023, data as of Dec 6, 2023.
3. C-CAT Investigation Results Statistical Information prepared by MHLW for 2021 and 2022.
4. Data on File, Foundation Medicine, Inc., 2022.
Important Safety Information
FoundationOne CDx
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
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.