Foundation Medicine

What Foundation Medicine does

Foundation Medicine is a molecular information company that develops and commercializes comprehensive genomic profiling (CGP) tests for advanced cancer patients, enabling oncologists to identify targeted therapy options, immunotherapy biomarkers, and clinical trial eligibility from a single test. Founded in 2010 and headquartered in Boston, Massachusetts, the company operates CLIA-certified, CAP-accredited, and ISO 15189-certified laboratories in Boston and Research Triangle Park, NC, plus a European facility in Penzberg, Germany. Its core products include the FDA-approved FoundationOne CDx (tissue-based, 324 genes) and FoundationOne Liquid CDx (blood-based, 324 genes), supplemented by FoundationOne RNA, FoundationOne Heme, FoundationOne PGx, FoundationOne MRD, and supplementary germline and IHC testing. The company holds over 100 FDA-approved companion diagnostic indications across the US and Japan, representing more than 50% of all approved US NGS CDx indications, and has supported the launch of more than 35 medicines through these approvals.

Foundation Medicine operates three core revenue streams: (1) per-test CGP testing services billed to Medicare, commercial insurance, and health systems; (2) companion diagnostic development, licensing, and royalties with biopharmaceutical partners; and (3) biopharma services spanning discovery, translational research, clinical development, and commercialization support. Its enterprise go-to-market is anchored by a field sales force and medical science liaisons targeting oncologists, pathologists, and healthcare systems, with active presence at major oncology conferences such as ASCO. The company is an independent subsidiary of Roche Holding AG (acquired in 2018 for approximately $2.4 billion) and benefits from distribution, clinical development, and pharmaceutical integration through the Roche ecosystem.

The company maintains proprietary data assets including the Flatiron Health-Foundation Medicine Clinico-genomic Database (over 150,000 patients) and has delivered more than 1.5 million CGP reports cumulatively. Recent strategic activity includes the announced acquisition of SAGA Diagnostics (up to $595 million) for MRD capabilities, multiple new product launches in 2024-2026, and expanded partnerships with biopharma leaders (Bristol Myers Squibb, ConcertAI, Manifold for AI, Fulgent Genetics, SWOG, Massive Bio). Foundation Medicine is not publicly traded as a subsidiary of Roche; the legacy "nasdaq:FMI" designation refers to its prior independent public listing prior to the 2018 acquisition.

Name

Foundation Medicine

Legal name

Foundation Medicine, Inc.

Website

https://foundationmedicine.com

Company type

Private

Founded year

2012

Operating status

Operating

Headcount range

251–500 employees

Ownership category

akta.pro rank

Product category

Molecular Diagnostics / Precision Oncology

NAICS

Medical Laboratories (621511), Medical and Diagnostic Laboratories (62151), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE)

akta.pro secondary industries

Companion Diagnostics (CDx) & Therapy Selection Assays (HLAAALAF), Companion Diagnostic (CDx) Co-Development Services (biopharma partnerships, clinical strategy) (HLAAAMAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Comprehensive genomic profiling
• Companion diagnostics
• Molecular diagnostics
• Precision oncology
• Cancer genomic testing

Headquarters

HQ city

Cambridge

HQ country

United States

HQ region

North America

Offices3 records

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Operations, Personnel, Marketing or Sales, Infrastructure, Supply Chain

Revenue model

1. Comprehensive Genomic Profiling Testing Services: Foundation Medicine generates revenue through laboratory testing services providing comprehensive genomic profiling to advanced cancer patients. Tests include FoundationOne CDx (tissue-based), FoundationOne Liquid CDx (blood-based), FoundationOne RNA, FoundationOne Heme, and supplementary tests. Revenue is generated on a per-test basis, typically billed to insurance, Medicare, or healthcare systems.
2. Companion Diagnostic Development and CDx Services: Collaboration with biopharmaceutical partners to develop and gain regulatory approval for companion diagnostic tests that identify patients who may benefit from specific targeted therapies. This includes FDA-approved companion diagnostic indications across FoundationOne CDx and FoundationOne Liquid CDx platforms, supporting drug approvals and treatment selection.
3. Biopharma Services: Comprehensive services for biopharmaceutical partners across the drug development lifecycle, including discovery and translational research, clinical development and companion diagnostics, and access and commercialization support. Revenue derived from service agreements, research collaborations, and strategic partnerships.

Pricing tiers

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

Foundation Medicine is a molecular information company that provides FDA-approved comprehensive genomic profiling tests for advanced cancer patients using next-generation sequencing on both tissue (FoundationOne CDx, 324 genes) and blood (FoundationOne Liquid CDx) samples. It also develops companion diagnostics in partnership with biopharmaceutical companies, provides biopharma services across the drug development lifecycle (discovery, clinical development, CDx, commercialization), and offers data analytics through its FoundationInsights platform.

Product overview

Foundation Medicine offers a portfolio of FDA-approved comprehensive genomic profiling tests for precision oncology. The core products include FoundationOne CDx (tissue-based NGS for solid tumors, 324 genes) and FoundationOne Liquid CDx (blood-based liquid biopsy, 324 genes with variant reporting in 311 genes). Additional testing modalities include FoundationOne RNA (RNA fusion detection, 318 genes), FoundationOne Heme (hematologic cancers), and supplementary tests (Germline Testing, IHC Testing, FoundationOne PGx pharmacogenetics). The newly launched FoundationOne MRD enables molecular residual disease detection for early-stage breast cancer recurrence monitoring. The company's data analytics platform FoundationInsights supports biopharma drug development. Foundation Medicine also recently announced acquisition of SAGA Diagnostics' Pathlight MRD platform.

Differentiator

Problem solved

Functional benefit

Brands

• FoundationOne CDx: FDA-approved tissue-based comprehensive genomic profiling test analyzing 324 genes
• FoundationOne Liquid CDx
• FoundationOne RNA
• FoundationOne Heme
• FoundationOne PGx
• FoundationInsights
• Pathlight
• FlexOMx Lab

Products and services

• FoundationOne CDx FDA-approved qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. Utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures to identify targeted therapy options, immunotherapy biomarkers, and clinical trial eligibility.
• FoundationOne Liquid CDx FDA-approved blood-based next-generation sequencing test analyzing 324 genes using circulating cell-free DNA. Reports short variants in 311 genes, rearrangements in 8 genes, and copy number alterations in 3 genes for advanced cancer patients.
• FoundationOne RNA Tissue-based RNA sequencing test covering 318 cancer-related genes for solid tumors. Provides combined DNA + RNA fusion detection to complement FoundationOne CDx.
• FoundationOne Heme Comprehensive genomic profiling test for hematologic cancers, analyzing relevant gene alterations to guide treatment decisions for patients with blood cancers.
• FoundationOne PGx Pharmacogenetic test analyzing genetic variants that influence how patients metabolize medicines, particularly for cancer therapy selection and dosing. Includes nine genes associated with oncology drug metabolism including DPYD, CYP2C19, and TPMT.
• FoundationOne MRD Molecular residual disease test for early-stage breast cancer. Uses blood-based genomic profiling to detect cancer recurrence with ultra-sensitivity. Medicare-covered for early-stage breast cancer recurrence monitoring.
• Germline Testing Supplementary testing service for identifying inherited genetic variants to support cancer risk assessment and treatment planning.
• IHC Testing Immunohistochemistry testing service for assessing protein expression in cancer specimens to support diagnostic and treatment decisions.
• FoundationInsights Data analytics platform providing real-world data offerings including multimodal datasets such as H&E slides and gene expression data to support biopharmaceutical partners in accelerating drug discovery and personalized therapy development.
• Biopharma Services Comprehensive services for biopharmaceutical partners across the drug development lifecycle, including discovery and translational research, clinical development and companion diagnostics (CDx), and access and commercialization support. Supports the global therapy development lifecycle from initial discovery to launch.

Quantifiable outcome

• Over 1.5 million patient comprehensive genomic profiling reports delivered
• +5 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Integration1 record

AI capability3 records

Feature6 records

Partnerships

Nine partnerships are on record, tiered core, strategic and minor.

• SWOG Clinical Trials PartnershipscoreStrategic or Co-development Partner · 1 June 2026Strategic collaboration to advance biomarker-driven research and clinical trials in cancer. Foundation Medicine provides genomic testing capabilities leveraging its companion diagnostic expertise, while SWOG CTP offers access to a nationwide network of over 1,300 investigation sites for patient enrollment.
• Fulgent GeneticscoreStrategic or Co-development Partner · 4 May 2026Expanded partnership to launch FoundationOne PGx, a pharmacogenetic testing offering designed to identify genetic variants influencing drug metabolism, particularly for cancer therapy selection and dosing. The panel includes nine genes associated with oncology drug metabolism including DPYD, CYP2C19, and TPMT to reduce adverse drug reactions and improve treatment effectiveness.
• Bristol Myers SquibbcoreStrategic or Co-development Partner · 21 April 2026Expanded collaboration to develop FoundationOne CDx as a next-generation sequencing companion diagnostic to identify patients with homozygous MTAP deletion for targeted therapies across multiple cancer indications. Builds on original 2017 partnership focused on predictive biomarkers in cancer and immunotherapy, which previously expanded in 2023 to include companion diagnostic for Augtyro.
• SAGA DiagnosticscoreStrategic or Co-development Partner · 16 April 2026Roche, through Foundation Medicine, agreed to acquire SAGA Diagnostics for up to $595 million to integrate SAGA's Pathlight tumor-informed MRD platform into Foundation Medicine's diagnostic portfolio. The Pathlight platform uses whole genome sequencing and digital PCR to detect cancer recurrence with ultra-sensitivity, currently covered by Medicare for early-stage breast cancer. Deal expected to close Q3 2026 pending regulatory approvals.
• RochecoreOthers · 16 April 2026Foundation Medicine is an independent subsidiary of Roche. Roche has entered into definitive agreement to acquire SAGA Diagnostics for up to $595 million with Foundation Medicine set to integrate SAGA's Pathlight MRD platform. The acquisition positions Foundation Medicine within Roche's broader precision oncology portfolio.
• ConcertAIstrategicStrategic or Co-development Partner · 12 January 2026Collaboration combining Foundation Medicine's genomic testing data with ConcertAI's clinical data to create the largest clinically-linked dataset in the industry, encompassing nearly half a million patients. Aims to support efficient drug development and real-world evidence research in oncology.
• AWS (Amazon Web Services)strategicTechnology or Integration · 26 November 2025AWS customer using cloud infrastructure and AI services. Foundation Medicine is among customers including Bayer AG, Natera, and others using AWS to build digitally connected labs for early-stage drug discovery and biomedical research.
• ManifoldstrategicTechnology or Integration · 30 October 2025Partnership to enhance FoundationInsights data analytics platform with AI capabilities. The collaboration combines extensive genomic datasets with advanced AI to accelerate drug discovery and personalized therapies. A targeted version for healthcare providers is planned for 2026.
• Massive BiominorStrategic or Co-development Partner · 13 September 2024Strategic partnership to enhance patient access to clinical trials through AI-driven patient matching. Leverages Massive Bio's digital platform and Foundation Medicine's genomic expertise to increase clinical trial participation and refine enrollment processes.

Scale indicators11 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Guardant Health: Guardant Health is a direct competitor in oncology liquid biopsy and comprehensive genomic profiling, offering Guardant360 CDx alongside tissue-based assays, with shared biopharma CDx and MRD ambitions.
• Caris Life Sciences: Caris competes head-to-head with Foundation Medicine in tissue-based CGP (MI Profile) and liquid biopsy, and is a direct peer in biopharma companion diagnostic development and real-world evidence generation.
• Tempus Labs: Tempus offers parallel CGP, liquid biopsy, and AI-driven multi-modal data products to oncologists and biopharma, positioning it as a direct peer in both clinical testing and data/analytics services.
• NeoGenomics: NeoGenomics is a direct peer in oncology diagnostics services, offering comprehensive solid tumor and hematologic profiling, with overlapping hospital and biopharma channels.
• Personalis: Personalis competes in tumor-informed MRD (NeXT Personal) and CGP for solid tumors, directly contesting both Foundation Medicine's tissue CGP and the new Pathlight MRD franchise.
• Natera: Natera is a direct peer in tumor-informed MRD (Signatera) and oncology molecular diagnostics, with comparable biopharma and clinical channels and overlapping Medicare-covered indications.

Broad incumbents

• Veracyte: Veracyte is a broader molecular diagnostics incumbent that has expanded into oncology CGP and urology-focused genomic tests, making it a broad incumbent peer in oncology diagnostics.
• Exact Sciences: Exact Sciences is a broad molecular diagnostics incumbent with Cologuard and an expanding oncology therapy-selection portfolio (Oncotype, Precision Oncology), competing with Foundation Medicine for biopharma CDx and oncology testing budgets.
• Illumina: Illumina is the dominant NGS platform provider underlying Foundation Medicine's tests; it is a broad incumbent whose sequencing technology roadmap, pricing, and own oncology products (e.g., TSO 500) shape Foundation Medicine's cost structure and competitive set.

Emerging players

• Adaptive Biotechnologies: Adaptive Biotechnologies is an emerging peer in immune-mediated MRD (clonoSEQ) and immuno-sequencing, directly contesting the hematologic and emerging MRD opportunities alongside Foundation Medicine's FoundationOne Heme and Pathlight platforms.

Market position

Strengths4 records

Weaknesses4 records

Competitive moat6 records

Key risks5 records

Key highlights6 records

Customer concentration

• Xx.com/FoundationATCG
• YouTubeyoutube.com/foundationmedicine
• LinkedInlinkedin.com/company/foundation-medicine

Compliance4 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles12 records

Subsidiaries1 record

Funding overview

Funding rounds4 records

Investors8 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A2 records

Investments2 records

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Foundation Medicine