Biopharma FAQs

Foundation Medicine is your partner to help accelerate biomarker-driven drug development - from target discovery to commercial launch, we can assist biopharma partners with the following offerings: 

Discovery & Translational Research

Our proven portfolio of high-quality comprehensive tests and our regulatory-ready dataset can be used for prospective patient selection and clinical trial enrollment, inform clinical trial design, or create new insights from your banked samples to define biomarkers, identify resistance, or determine which patients could benefit from your therapy.

Clinical Development & Companion Diagnostics (CDx) 

Our FoundationOne CDx and FoundationOne Liquid CDx tests have 60% of all CDx approvals for NGS testing in the United States and Japan – the most of any diagnostic company – and we have capabilities to develop our portfolio for the upcoming European Union In Vitro Diagnostics Regulation (EU IVDR).

Access & Commercialization

We provide broad access to precision medicine around the world, with our tests available in more than 100 countries, and offer flexible solutions to accelerate the commercial launch for your new treatment or indication. 

FoundationCore^® is a molecular information knowledgebase that contains genomic information from more than 500,000 patients whose tumors have been profiled by Foundation Medicine. Our partners can access and query this knowledgebase through our de-identified web-based platform, FoundationInsights^®, or can collaborate directly with our Cancer Genomics Research scientists in bespoke projects. This dataset is notably enriched for rare cancers relative to population prevalence, making it an invaluable source for genomic targeting of populations with high unmet medical need. 

Foundation Medicine offers both liquid and tissue next-generation sequencing (NGS) comprehensive genomic profiling (CGP) cancer assays to enable a synergistic approach to support drug development.

Enrollment and Regulatory Strategy

• Leveraging both platforms can support accelerating enrollment by providing more access to subjects who may not have the ability to provide a tissue biopsy

• Having a synergistic tissue approach enables reflex to tissue if the liquid biopsy has insufficient ctDNA, as well as a regulatory strategy leveraging both tissue and liquid to broaden access to subjects once the therapy is on market

Liquid biopsy can also accelerate learnings to inform drug development pipelines by

• Translational learning through ctDNA resistance analysis¹

• Monitoring ctDNA dynamics for early insights into treatment effect²

• Early information from ctDNA, through treatment response monitoring, could inform approaches to treatment by helping stratify subjects with a high risk of resistance who might be candidates for escalation, versus those with a low risk of recurrence who might benefit from de-escalation to reduce risk of toxicities³

• Detectable ctDNA following surgery or neoadjuvant treatment for early-stage cancers, known as molecular residual disease, is associated with a high risk of recurrence and could provide valuable risk stratification information for making adjuvant treatment decisions⁴

References:

¹ Awad MM, et al. Acquired resistance to KRAS G12C Inhibition in Cancer. N Engl J Med. 2021;384(25):2382-2393.

² Cheng ML, Lau CJ, Milan MS, Supplee JG, Riess JW, Bradbury PA, Jänne PA, Oxnard GR, Paweletz CP. Plasma ctDNA Response Is an Early Marker of Treatment Effect in Advanced NSCLC. JCO Precision Oncology. 2021 Feb;5:393-402.

³ Dasari A, Morris VK, Allegra CJ, et al. ctDNA applications and integration in colorectal cancer: an NCI Colon and Rectal-Anal Task Forces whitepaper. Nat Rev Clin Oncol. 2020;17(12):757-770. doi:10.1038/s41571-020-0392-0

⁴ Tie J et al. Circulating Tumor DNA Analyses as Markers of Recurrence Risk and Benefit of Adjuvant Therapy for Stage III Colon Cancer [published correction appears in JAMA Oncol. 2019 Dec 1;5(12):1811]. JAMA Oncol. 2019;5(12):1710-1717. doi:10.1001/jamaoncol.2019.3616

Foundation Medicine sits at the nexus of medicine and pharmaceutical research, combining our multi-faceted expertise with more than 500,000 sequenced patient samples and over 65 pharmaceutical partners. We help our partners optimize their clinical trials in a number of ways: 

Trial Design 

Utilize more than 500,000 profiles in the FoundationCore knowledgebase to define biomarker criteria, map geographic ordering patterns, and select sites with the highest testing volumes. 

Trial Screening for Enrollment 

Find and enroll patients efficiently from real-world testing, including those with rare genomic findings. We profile thousands of new patients per week. 

Learn more about our solutions for clinical development and CDx

FoundationInsights^TM is a secure web application, which pulls data from our FoundationCore® knowledgebase of more than 500,000 de-identified patient genomic profiles, spanning more than 150 cancer subtypes.

Learn more about our solutions for discovery and translational research

For biopharma partners who would like to speak to someone on our Biopharma Team or learn more about our portfolio for biopharma and research partners, please reach out to Biopharma.leads@foundationmedicine.com.

For technical support for our Partner Portal, please contact our dedicated team to help at partnerportalsupport@foundationmedicine.com.

For study management support, please contact your partner sponsor or study contact. If you’re not sure who to contact, please reach out at clinicaltrials@foundationmedicine.com.