Foundation Medicine, Inc. - Global Leader in Cancer Genomics and Companion Diagnostics

Company Overview (Updated April 2026)

Foundation Medicine, Inc. is a precision medicine company transforming cancer care through comprehensive genomic profiling (CGP) and companion diagnostics. Founded in 2010 and headquartered in Cambridge, Massachusetts, USA, the company has established itself as the global leader in high-quality genomic testing. Foundation Medicine was acquired by Roche Group (SIX: RO, ROG; OTCQX: RHHBY) in 2018 for approximately $2.4 billion and currently operates as a wholly-owned subsidiary.

Corporate Structure (2024 Reorganization):

- Parent Company: Roche Group, Basel, Switzerland (2024 Group Revenue: CHF 60.4 billion / ~$67.4 billion)

- Business Unit: Transferred from Roche Pharmaceuticals Division to Roche Diagnostics Division effective January 1, 2024

- Headquarters: Cambridge, Massachusetts, USA (Primary operations)

- International Presence: Operations in the U.S., Japan, and global markets

Historical Evolution:

- 2010: Company founded in Cambridge, MA

- 2016: FDA approved FoundationFocus CDx BRCA - first NGS-based companion diagnostic

- 2017: FDA approved FoundationOne CDx - first pan-cancer (all solid tumors) comprehensive genomic profiling test (324 genes)

- 2018: Acquired by Roche Group for ~$2.4 billion; became wholly-owned subsidiary

- 2020: FDA approved FoundationOne Liquid CDx - liquid biopsy version using circulating cell-free DNA

- 2024: Business operations moved from Roche Pharmaceuticals to Roche Diagnostics Division

- December 2025: Achieved 100th companion diagnostic approval milestone (57 U.S., 43 Japan)

- April 2026: Acquired Saga Diagnostics for $595 million to expand into MRD testing

2024-2025 Major Developments & Regulatory Breakthroughs

Historic 100th Companion Diagnostic Milestone (December 2025)

Unprecedented Achievement:

- First and only company to reach 100 approved companion diagnostic indications for NGS testing globally

- Breakdown: 57 approvals in the United States, 43 approvals in Japan

- Key regulatory approvals span FoundationOne CDx (tissue-based) and FoundationOne Liquid CDx (blood-based)

- Latest Japan MHLW approval for NTRK fusion-positive solid tumors (December 2025) marked the 100th milestone

Significance: Companion diagnostics are the gold standard in personalized cancer care, undergoing extensive testing and review by independent regulatory agencies to accurately match patients to targeted therapies.

Pediatric Oncology Breakthrough (January 2025)

FDA Approval for OJEMDA (tovorafenib):

- FoundationOne CDx approved as the first and only companion diagnostic for Day One Biopharmaceuticals' OJEMDA

- Indication: Treatment of patients 6 months and older with relapsed or refractory pediatric low-grade glioma (pLGG) harboring BRAF fusions, rearrangements, or BRAF V600 mutations

- pLGG represents the most common brain tumor diagnosed in children; BRAF alterations detected in up to 75% of cases

- Previously, no FDA-approved treatments existed targeting tumors with BRAF fusions (representing 80% of BRAF-altered patients)

- Foundation Medicine is the only company offering both tissue and blood-based FDA-approved CGP tests

European Regulatory Progress (February 2026):

- On February 27, 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for OJEMDA, recommending its approval in the European Union for pediatric LGG

- This follows the U.S. approval and supports the goal of bringing this treatment to patients with BRAF-altered pLGG globally

2026 Strategic Expansion & Acquisitions

Saga Diagnostics Acquisition (April 2026)

Transaction Details:

- On April 17, 2026, Roche announced the acquisition of Saga Diagnostics for $595 million (~EUR 540 million)

- Saga Diagnostics is a Swedish company based in Lund, specializing in molecular residual disease (MRD) testing

- Key asset: Pathlight MRD platform, combining proprietary digital PCR (dPCR) and whole genome sequencing technologies

- EnAbles detection of circulating tumor DNA (ctDNA) at the earliest signs of cancer recurrence or disease progression

Strategic Rationale:

- MRD testing represents one of the fastest-growing areas in diagnostics, expanding the precision medicine lifecycle beyond initial diagnosis

- Allows earlier intervention and treatment modification based on molecular evidence of disease recurrence

- Complements Foundation Medicine's existing CGP portfolio (FoundationOne CDx/Liquid CDx and FoundationOne Monitor)

- Advances the vision of continuous cancer care through serial molecular profiling

CEO Statement: Dan Malarek, CEO of Foundation Medicine, stated: "As part of Roche's global network, this acquisition allows us to expand the impact of our best-in-class precision medicine services into the management of longitudinal cancer care, enabling clinicians to optimize treatment approaches for their patients across all stages of the disease."

OJEMDA Commercial Landscape Update (March 2026)

Servier Acquisition of Day One Biopharmaceuticals:

- On March 6, 2026, Servier announced the acquisition of Day One Biopharmaceuticals (OJEMDA's developer) for approximately $2.5 billion

- Transaction expected to close in Q2 2026, subject to regulatory approvals

- OJEMDA was Day One's lead asset; it generated U.S. net sales of approximately $100 million in the first year post-FDA approval (April 2024-April 2025)

- Ipsen retains ex-U.S. rights to OJEMDA (except in Japan where Day One retains rights), while Servier will acquire all other Day One assets including oncology pipeline

- FoundationOne CDx remains the exclusive companion diagnostic for OJEMDA regardless of commercial ownership changes

Financial Context & Roche Group Integration (2024-2025)

Roche Group Financial Performance (Parent Company)

2024 Full Year (Roche Group Consolidated):

- Group Revenue: CHF 60.44 billion (~$67.4 billion USD), +6% at constant exchange rates (CER)

- Pharmaceuticals Division: CHF 46.17 billion (+7% CER)

- Diagnostics Division: CHF 14.45 billion (+4% CER) - now includes Foundation Medicine as of January 1, 2024

- Diagnostics Segment Breakdown:

- Core Lab: CHF 8.0 billion (+7% CER)

- Molecular Lab: CHF 2.17 billion (+4% CER)

- Pathology Lab: CHF 1.56 billion (+7% CER)

- Point of Care: CHF 1.67 billion (+1% CER)

- Diabetes Care: CHF 0.92 billion (incl. newly acquired products)

2024 Organizational Change Impact:

- Foundation Medicine business moved from Pharmaceuticals Division to Diagnostics Division effective January 1, 2024

- 2023 financial results restated to reflect this operational reorganization

- 2023 impairment of property, plant and equipment at Foundation Medicine recorded (pre-transfer)

- Administration costs in 2024 increased partly due to lease of Foundation Medicine offices in Boston

Foundation Medicine Market Position

Competitive Landscape:

- Holds 50% of all approved companion diagnostic indications for NGS testing in the United States and Japan

- Sequenced over 2,200 pediatric central nervous system tumors (as of March 2024)

- Global leader in comprehensive genomic profiling for solid tumors

- Only company offering both FDA-approved tissue-based (FoundationOne CDx) and blood-based (FoundationOne Liquid CDx) CGP tests

Core Products & Technology Platforms

FoundationOne CDx (Tissue-Based)

FDA-Approved Comprehensive Genomic Profiling:

- Next-generation sequencing-based in vitro diagnostic device

- Analyzes 324 genes for substitutions, insertion/deletion alterations (indels), copy number alterations (CNAs)

- Detects select gene rearrangements and genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB)

- Uses DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens

- Pan-tumor companion diagnostic for all solid tumors

- 57 FDA-approved companion diagnostic indications (as of December 2025)

FoundationOne Liquid CDx (Blood-Based/Liquid Biopsy)

FDA-Approved Liquid Biopsy Platform:

- Qualitative NGS test using circulating cell-free DNA (cfDNA) isolated from plasma

- Analyzes 324 genes utilizing targeted high-throughput hybridization-based capture technology

- Approved to report short variants in 311 genes

- Companion diagnostic to identify patients for specific targeted therapies

- Minimally invasive alternative when tumor tissue is unavailable

- ctDNA tumor fraction reporting (high/low) to guide clinical decision-making

- Important limitation: Patients negative for companion diagnostic mutations should be reflexed to tumor tissue testing when feasible

Molecular Residual Disease (MRD) - New Capability (2026)

Pathlight MRD Platform (via Saga Diagnostics Acquisition):

- Proprietary digital PCR (dPCR) and whole genome sequencing technologies

- Detects circulating tumor DNA (ctDNA) at the earliest signs of cancer recurrence

- Enables longitudinal monitoring of cancer patients post-treatment

- Complements existing CGP tests to provide continuous care across the patient journey

- Applications in treatment response monitoring and early recurrence detection

Hematologic Malignancies & Research Portfolio

FoundationOne Heme: New York State-approved test for hematologic malignancies (tissue or blood-based biopsy)

FoundationOne RNA: Test for gene fusions and transcriptome analysis

FoundationOne Monitor: Circulating tumor DNA (ctDNA) monitoring test for research use (tracks ctDNA levels to monitor treatment response)

Corporate Structure & Leadership (2026)

Executive Management Team

Chief Executive Officer: Dan Malarek - Leading company strategy and operations; oversaw Saga Diagnostics acquisition integration

Chief Financial Officer & Corporate Management: Dominique Schutz - Oversees financial operations and corporate strategy

Chief Medical Officer: Todd Druley, M.D., Ph.D. - Guides clinical and medical strategy, physician engagement

Chief Operating Officer: Vera Grossmann - Manages operational execution and service delivery

Chief Commercial Officer: Troy Schurr - Leads commercial strategy, market expansion, and biopharma partnerships

Senior Vice President, Head of Research and Development: Lucas Dennis, Ph.D. - Drives product innovation, pipeline development, and scientific advancement

General Counsel & Chief Legal Officer: Winifred Lynn Swan - Oversees legal, regulatory, and compliance functions

Head of International Business: Marlene Thomas - Manages global expansion and international operations (particularly Japan and EU markets)

Company Information Summary

Full Legal Name: Foundation Medicine, Inc.

Founded: 2010

Headquarters: Cambridge, Massachusetts, USA

Parent Company: Roche Holding AG (SIX: RO, ROG; OTCQX: RHHBY), Basel, Switzerland

Acquisition Date: 2018 (acquired for ~$2.4 billion)

Business Unit (as of 2024): Roche Diagnostics Division

Company Type: Wholly-owned subsidiary of Roche Group

Industry: Precision Medicine / Cancer Genomics / In Vitro Diagnostics (IVD)

Specialty: Comprehensive Genomic Profiling (CGP), Companion Diagnostics (CDx), and Molecular Residual Disease (MRD) monitoring

Competitive Position & Strategic Differentiation

Market Leadership

Unmatched Regulatory Portfolio:

- 100 approved companion diagnostic indications (first and only company globally)

- 50% market share of all approved CDx indications for NGS in U.S. and Japan

- Only company with FDA-approved tissue and blood-based CGP tests

Key Competitive Advantages:

- Comprehensive Gene Coverage: 324-gene panel vs. competitors' smaller panels

- Regulatory Excellence: Parallel FDA/CMS review process pioneer (landmark national Medicare coverage)

- Clinical Validation: Extensive evidence generation with 2,200+ pediatric CNS tumors sequenced

- Roche Integration: Access to global diagnostics infrastructure and pharmaceutical partnerships

- MRD Expansion (2026): Unique combination of CGP and MRD capabilities through Saga Diagnostics acquisition

Key Competitors:

- Guardant Health: Liquid biopsy and CGP competitor (Guardant360), strong in MRD with Guardant Reveal

- Tempus: AI-driven precision medicine and genomic profiling

- Caris Life Sciences: Molecular profiling and companion diagnostics

- Illumina (Grail): Multi-cancer early detection (Galleri test)

- Myriad Genetics: Hereditary cancer testing and companion diagnostics

- Natera: MRD testing leader (Signatera) - primary competitor in newly entered MRD space

Strategic Direction & 2026-2027 Outlook

Growth Drivers

Molecular Residual Disease (MRD) Expansion:

- Integration of Pathlight MRD platform to enter the fastest-growing area of diagnostics

- Expansion from diagnostic profiling to longitudinal disease monitoring

- Competition with Natera Signatera and Guardant Reveal in the MRD monitoring space

Companion Diagnostic Expansion:

- Continued pursuit of additional CDx indications beyond the 100th milestone

- Expansion of liquid biopsy applications in earlier-stage cancer detection

Pediatric Oncology Focus:

- Building on OJEMDA approval to expand pediatric CDx portfolio

- Addressing unmet needs in rare pediatric cancers (pLGG represents largest pediatric brain tumor segment)

- European approval expected following CHMP positive opinion (February 2026)

International Expansion:

- Continued growth in Japan (43 approvals) and EU markets

- Leveraging Roche's global diagnostics distribution network

- Integration with Roche's international biopharma partnerships

Contact Information

Headquarters

Address: Foundation Medicine, Inc., Cambridge, Massachusetts, USA
   Website: www.foundationmedicine.com
   International Website: www.rochefoundationmedicine.com
   Media Contact: Abigail Linehan, 781-534-3210, newsroom@foundationmedicine.com
   Biopharma Partners: partner@foundationmedicine.com

Parent Company (Roche Group)

Headquarters: Basel, Switzerland
   Investor Relations: www.roche.com/investors
   Diagnostics Division: diagnostics.roche.com

Keywords: Foundation Medicine, FoundationOne CDx, FoundationOne Liquid CDx, Roche, companion diagnostics, CGP, comprehensive genomic profiling, Dan Malarek, 100 companion diagnostic indications, OJEMDA, tovorafenib, pediatric low-grade glioma, Saga Diagnostics, Pathlight MRD, molecular residual disease, liquid biopsy, ctDNA, Cambridge, 2010, precision medicine, cancer genomics, 2026 acquisition