FoundationOne

by Foundation Medicine  · Based in United States → — Transforming Precision Medicine
Oncology Pathology
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Regulatory Status Disclosed

Overview

FoundationOne is a portfolio of comprehensive genomic profiling (CGP) solutions developed by Foundation Medicine to identify clinically actionable alterations in cancer. The suite includes FoundationOne CDx (a tissue-based companion diagnostic for solid tumors), FoundationOne Liquid CDx (a blood-based assay), and specialized tests such as FoundationOne Heme, FoundationOne RNA, and FoundationOne PGx.

Target Specialties & Care Settings:

  • Oncology & Hematology: Used in outpatient clinics, academic medical centers, and community oncology practices to guide personalized treatment selection and clinical trial matching.
  • Pathology: Integrates with laboratory workflows to support diagnostic classification and biomarker evaluation.

Clinical Workflow Integration:

  • Ordering & Specimen Collection: Physicians order the test through an online portal and submit either a formalin-fixed, paraffin-embedded (FFPE) tissue sample or a peripheral blood draw.
  • Analysis & Interpretation: Next-generation sequencing (NGS) is performed to detect substitutions, insertions, deletions, copy number alterations, and select gene rearrangements.
  • Reporting: Results are delivered in a consolidated clinical report that details detected genomic alterations, companion diagnostic indications, and potential therapeutic options, including relevant clinical trials.

Notable Capabilities:

  • Broad Biomarker Detection: Assesses key genomic signatures, including Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI).
  • AI-Enabled Analytics: Utilizes advanced bioinformatics and AI-powered data tools to process complex genomic criteria, accelerating clinical interpretation and research insights.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Comprehensive Genomic Profiling (CGP) for solid tumors
  • AI-assisted interpretation of genomic alterations
  • Informs cancer treatment decisions
  • Identifies clinical trial opportunities
  • DNA + RNA fusion detection (with FoundationOne RNA)
  • Companion diagnostics (CDx)
  • EMR integrations
  • Decision support services
  • Report interpretation & support
  • Medical education & resources

Use Cases

  • Guiding treatment strategies for advanced cancer patients
  • Informing targeted therapies
  • Informing immunotherapies
  • Identifying relevant clinical trial options
  • Biomarker discovery for drug development
  • Supporting patient care with precision medicine reports

What Physicians Need to Know

Clinical Trial Matching
FoundationOne reports include information about relevant clinical trials based on a patient's unique genomic profile, helping to match patients with appropriate investigational therapies.
Real-World Evidence Analysis
Foundation Medicine leverages its extensive proprietary dataset of de-identified genomic results from over 800,000 patients, combined with clinical data, to generate real-world evidence (RWE). This data is utilized through platforms like FoundationInsightsu00ae with AI-enabled analytics to accelerate drug discovery and development.
Genomic Data Integration
FoundationOne utilizes Next-Generation Sequencing (NGS) to integrate various genomic alteration classes, including substitutions, insertions/deletions, copy number alterations, and gene rearrangements, across hundreds of cancer-related genes. It also assesses complex genomic signatures like Tumor Mutational Burden (TMB) and Microsatellite Instability (MSI). FoundationOneu00aeRNA further enhances this by providing RNA sequencing for fusion detection and gene expression reporting.
Literature Mining
FoundationOne reports incorporate literature-based guidance on potential treatment options and relevant clinical trials, providing a customized and timely literature review to support clinical decision-making.
Target Identification
By comprehensively profiling tumor genomics, FoundationOne directly aids in identifying specific therapeutic targets (e.g., gene alterations, fusions) that can be addressed with matched approved or investigational therapies.
Safety Signal Detection
FoundationOne is a diagnostic tool focused on identifying genomic alterations for treatment efficacy and patient selection, rather than direct safety signal detection. Safety monitoring is typically conducted in clinical trials and post-market surveillance of drugs.
Collaboration Features
Foundation Medicine actively collaborates with biopharmaceutical companies (e.g., Bristol Myers Squibb, Merck, AstraZeneca, Novartis), academic institutions, and oncology networks (e.g., OneOncology) to develop companion diagnostics, accelerate drug development, and advance precision oncology.
Publication Support
Foundation Medicine has contributed to over 1,000 peer-reviewed publications, demonstrating its commitment to advancing scientific understanding in cancer genomics. Their data and research are frequently published and support the broader scientific community.
Physician Tip

For optimal patient care, utilize FoundationOne for comprehensive genomic profiling to identify actionable alterations, match patients to targeted therapies and relevant clinical trials, and understand complex biomarkers like TMB and MSI. The streamlined reports offer literature-based guidance, aiding in personalized treatment planning, especially for advanced cancers. Consider both tissue-based (FoundationOne CDx) and liquid biopsy (FoundationOne Liquid CDx) options based on tissue availability and clinical context.

FoundationOne integrates advanced NGS technology with proprietary bioinformatics pipelines for robust genomic analysis. It connects with clinical data platforms, such as FoundationInsightsu00ae and previously Flatiron Health's OncoCloud, to enable real-world evidence generation and AI-powered analytics for drug discovery. Its companion diagnostic approvals signify direct integration with specific targeted drug therapies, streamlining patient identification for approved treatments.

Details

Category Drug Discovery & Research, Oncology AI, Pathology AI
Pricing Contact for pricing
  • Tests typically range from $5,800 to $7,200; however, Foundation Medicine works with insurance providers and offers financial assistance programs
  • Medicare covers all Foundation Medicine tests for qualifying patients
DeploymentLab-based service with digital report delivery and EMR integrations.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

FoundationOne CDx is an FDA-approved comprehensive genomic profiling test for solid tumors, providing information for five tumor types: ovarian, lung, breast, colorectal, and melanoma.
Integrations
EHR Not specified
Specialties Oncology, Pathology

What the Web Says

FoundationOne offers comprehensive genomic profiling (CGP) tests for cancer patients, analyzing tumor DNA and RNA to identify genetic alterations and inform personalized treatment plans. The tests, such as FoundationOne CDx and FoundationOne Liquid CDx, are FDA-approved and covered by Medicare for certain indications. While some patients and physicians find the results highly beneficial for tailoring therapies and identifying clinical trial options, others report that the tests did not provide actionable mutations or that samples were insufficient for analysis. The cost of the tests can be a concern, though financial assistance programs are available.

Overall: Mixed

Strengths

  • Comprehensive genomic profiling for various cancer types, including solid tumors, hematological malignancies, and sarcomas.
  • Identifies all four classes of genomic alterations: base substitutions, insertions/deletions, copy number alterations, and rearrangements.
  • Analyzes hundreds of genes and genomic signatures like TMB and MSI to guide immunotherapy and targeted therapy decisions.
  • FDA-approved with Medicare coverage for specific indications, increasing accessibility for some patients.
  • Provides detailed reports with potential targeted therapy options and relevant clinical trials.
  • Offers both tissue-based (FoundationOne CDx) and liquid biopsy (FoundationOne Liquid CDx) options for flexibility in sample collection.

Limitations

  • High cost, with tests ranging from $5,800 to $7,200, and insurance coverage not always guaranteed.
  • Results may not always provide actionable mutations or lead to a change in treatment plan.
  • Some samples may be deemed insufficient for analysis due to low tumor content or degradation.
  • The utility of NGS sequencing as initial testing for all patients with non-small cell lung cancer (NSCLC) has not been definitively proven.
  • Can be a learning curve for healthcare providers not experienced with genomic testing and its implications.
  • Customer service wait times and occasional software crashes have been reported for related Foundation software.

Based on reviews from: Reddit, BioWorld, Capterra, G2, Nanalyze, HCPLive, Targeted Oncology, PLOS One - Research journals, Indeed.com, PMC

Last updated: 2026-07-24

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Press & Coverage

Business Wire
Foundation Medicine Launches FoundationOneu00aeMRD, First-of-Its-Kind Molecular Residual Disease Test to Combine Structural Variants and Digital PCR
Foundation Medicine launched FoundationOneu00aeMRD, a molecular residual disease (MRD) test that combines structural variants and digital PCR for ultra-sensitive MRD detection with high specificity and accelerated turnaround time. This launch follows Roche's acquisition of SAGA Diagnostics and is covered by Medicare for cancer recurrence monitoring in early-stage breast cancer.
2026-05
CancerNetwork
FDA Approves FoundationOne CDx for Tepotinib in MET+ NSCLC
The FDA approved FoundationOne CDx as a companion diagnostic for identifying patients with nonu2013small cell lung cancer (NSCLC) harboring MET exon 14 skipping alterations who may benefit from tepotinib. This approval is notable as it's the first to leverage the companion diagnostic's real-world datau2013based service to support label expansion.
2026-05
Business Wire
U.S. Food and Drug Administration Approves FoundationOneu00aeCDx as a Companion Diagnostic for TEPMETKOu00ae (tepotinib) to Identify Patients with MET Exon 14 Skipping Alterations in Non-Small Cell Lung Cancer
The FDA approved FoundationOne CDx as a companion diagnostic for tepotinib in metastatic non-small cell lung cancer with MET exon 14 skipping alterations, expanding testing options for these patients. This approval, along with the prior FoundationOne Liquid CDx approval, provides both tissue- and blood-based FDA-approved testing options.
2026-05
Fulgent Genetics
Foundation Medicine to Launch Hereditary Germline Tests, FoundationOneu00aeGermline and FoundationOneu00aeGermline More, in the United States Through a Partnership with Fulgent Genetics
Foundation Medicine announced a partnership with Fulgent Genetics to launch FoundationOneu00aeGermline and FoundationOneu00aeGermline More in the U.S. These tests identify genetic variants associated with hereditary cancers and can be combined with Foundation Medicine's comprehensive genomic profiling tests for a more complete molecular profile.
2025-02
Targeted Oncology
FDA Approves FoundationOne CDx as Companion Diagnostic for Tovorafenib in Pediatric Low-Grade Glioma
The FDA approved FoundationOne CDx as the first companion diagnostic for tovorafenib in pediatric low-grade glioma (pLGG) with BRAF mutations or rearrangements. This next-generation sequencing test analyzes 324 genes, providing precise data to guide therapy decisions for this patient population.
2025-01
PLOS One
Clinical and analytical validation of FoundationOneu00aeCDx, a comprehensive genomic profiling assay for solid tumors
This research article details the clinical and analytical validation of FoundationOneu00aeCDx, a comprehensive genomic profiling assay for solid tumors. The study highlights its use of next-generation sequencing (NGS) to examine 324 cancer genes and its FDA approval as a companion diagnostic for 28 drug therapies.
2022-03
FDA
FoundationOne CDx u2013 P170019/S029
The FDA expanded the indications for use of the FoundationOne CDx test to include patients with solid tumor cells that have a high level of microsatellite instability (MSI-H status). This helps doctors identify if patients with solid tumors might be eligible to receive treatment with KEYTRUDA (pembrolizumab).
2022-03
OncLive
FDA Approves FoundationOne Liquid CDx For New Indications in Advanced Ovarian, Breast, and NSCLC
The FDA approved FoundationOne Liquid CDx as a companion diagnostic for three targeted therapies in advanced ovarian, breast, and nonu2013small cell lung cancer (NSCLC). The approval also expanded the diagnostic's label to report additional select copy number alterations and genomic rearrangements.
2020-10

Videos

Product demos, reviews, and walkthroughs for FoundationOne.

View all on YouTube

Frequently Asked Questions

FoundationOne tests, such as FoundationOne CDx and FoundationOne Liquid CDx, provide comprehensive genomic profiling that can identify actionable biomarkers, which is crucial for drug discovery. They serve as platforms for companion diagnostic development for biopharma companies, helping to streamline the identification of patients who may benefit from specific targeted therapies in clinical trials.
FoundationOne CDx is an FDA-approved companion diagnostic test, and FoundationOne Liquid CDx also holds FDA approval for certain indications, demonstrating rigorous analytical and clinical validation. Foundation Medicine's laboratories are CLIA-certified and CAP-accredited, ensuring high-quality standards for both clinical and research testing.
Alternatives to FoundationOne include tests like Guardant360, Tempus xT, and Caris Molecular Intelligence. While FoundationOne CDx analyzes over 300 cancer-related genes, other platforms may offer different gene panels, coverage depths, or incorporate additional analyses like RNA expression. Comparative studies suggest varying clinical utility and turnaround times among these platforms, with some offering broader gene coverage or faster results.
The list price for FoundationOne tests can be substantial, with FoundationOne CDx and FoundationACT listed around $5,800, and FoundationOne Heme at $7,200. For clinical use, Foundation Medicine offers financial assistance programs and works with insurance providers, with many commercially insured and Medicare patients having low or no out-of-pocket costs. Specific pricing for pure research use may vary and would typically be negotiated through biopharma partnerships.
Limitations include the inability to consistently detect alterations at allele frequencies below the established limit of detection, and potential decreased sensitivity for certain copy number alterations in samples with low tumor content. The tests do not distinguish between germline and somatic alterations, and a negative result does not rule out the presence of a mutation below the assay's detection limits.
FoundationOne CDx and Liquid CDx analyze over 300 cancer-related genes to detect various genomic alterations, including substitutions, insertions, deletions, copy number alterations, and gene rearrangements. They also report on genomic signatures like microsatellite instability (MSI) and tumor mutational burden (TMB), providing a comprehensive genomic blueprint valuable for identifying potential drug targets and understanding cancer biology in research.
FoundationOne CDx typically requires formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples, while FoundationOne Liquid CDx utilizes circulating cell-free DNA from a blood sample. The turnaround time for results is generally between 10 and 14 days after samples are received.

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Suggest an Edit → | Last Verified: 2026-04-24 | First Added: 2026-04-24

Investors who backed FoundationOne

Funded through the company that built this tool.
Roche Venture Fund
Corporate VC T3
Basel, Switzerland
$1M-$5M
Roche Venture Fund is the corporate venture arm of Roche, one of the largest pharmaceutical and diagnostics companies in the world, investing…
Biotech Diagnostics
David Krane
Solo Angel AI T3
San Francisco, United States
<$250k
David Krane is CEO of GV (formerly Google Ventures) and angel-invests from San Francisco at $250k+ checks at seed and Series A,…
AI/ML in Healthcare Health IT / Healthcare Software
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