Biomarker Discovery & Translational Research

Our solutions can support your early-stage therapy development programs with biomarker discovery, translational research, and clinical trial design

Biomarker Discovery

Leverage our comprehensive NGS testing for biomarker discovery and validation

Translational Research

Gain early research insights utilizing our ctDNA monitoring portfolio

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Clinical Trial Design

Answer your research question or inform your trial design with our clinical and genomics data

Comprehensive NGS testing

Our genomic profiling can identify a range of biomarkers from common point mutations to complex gene-expression signatures.

Our portfolio can inform your clinical trials by expanding your target patient population and accelerating your therapy development.

  • Tissue- and blood-based NGS tests
  • New research use capabilities in tissue, including genomic signatures like HRD and complex alterations like MTAP loss
  • RNA testing for actionable fusion detection and capabilities to offer gene expression reporting of over 1,500 genes
  • Heme testing for identifying biomarkers specific to heme malignancies

New Research Capabilities

  • Innovative biomarkers, such as HRD testing using our HRDsig for your PARP inhibitor clinical trial needs
  • New research use capabilities in biomarker discovery, including whole-genome methylation sequencing from blood and gene expression profiling across 20,0000+ genes from tissue samples

ctDNA Monitoring

Circulating tumor DNA (ctDNA) monitoring can advance your translational research
  • Evaluate changes in ctDNA levels over time to assess and optimize dose selection in early-phase clinical trials2
  • Quantify ctDNA tumor fraction, a biomarker that incorporates multi-omic information to improve sensitivity and maintain high specificity to monitor ctDNA levels3
  • Monitor individual variants and identify acquired resistance to therapy across more than 300 genes

Download our ctDNA Monitoring Overview

Real-World Data Solutions

Real-World Data (RWD) can help you find answers

Utilize our data to evaluate relevant questions for your biomarker research and clinical trials including biomarker prevalence and market size, combination therapy strategy, and clinical trial inclusion/exclusion criteria

Foundation Medicine has a portfolio of data solutions to enable your biomarker discovery journey

Download our CGDB Analytical Services Overview

Real World Data

  • FoundationCore® has comprehensive genomic data from more than 800k patient tumor samples
  • Flatiron Health Foundation Medicine Clinico-Genomic Database (CGDB) is a unique data resource that contains data from more than 125,000 patients4

Web-based Data Tool

  • FoundationInsights® is a web-based visualization tool used to analyze genomic data to inform clinical trial design and understand biomarker populations

Data Analysis

  • Custom Genomic Analysis provides custom analyses tailored to your needs to understand research questions including solid/liquid concordance, PD-L1 IHC data, and co-occurrence analyses
  • CGDB Analytical Services leverages the power of the Flatiron Health-Foundation Medicine CGDB to answer decisions in therapy clinical development

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:

Clinical Trial & CDx Development

Biomarker Testing Access & Commercialization

Need More Details? 

We are here to help. Contact our Biopharma Team for more information. 

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  1. Collier A, Bardia A, Sohn J, et al. Circulating tumor DNA dynamics in acelERA Breast Cancer: a Phase II study of giredestrant for estrogen receptor-positive, HER2-negative, previously treated advanced breast cancer. Presented at SABCS 2023. Abstract #PO1-05-07. 4
  2. Elamin YY, Nagasak M, Shum E, et al. BLU-945 monotherapy and in combination with osimertinib in previously treated patients with advanced EGFR-mutant NSCLC in the phase 1/2 SYMPHONY study. ASCO 2023. DOI: 10.1200/JCO.2023.41.16_suppl.9011 Journal of Clinical Oncology 41, no. 16_suppl (June 01, 2023) 9011-9011.
  3. Reichert, Z.R., et al. Annals of Oncology. 2022. DOI:https://doi.org/10.1016/j.annonc.2022.09.163.
  4. Data on file, Foundation Medicine, Inc., 2023.

Important Safety Information

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FoundationOne CDx and FoundationOne Liquid CDx

FoundationOne®CDx and FoundationOne®Liquid CDx are qualitative next-generation sequencing based in vitro diagnostic tests for advanced cancer patients with solid tumors and are for prescription use only. FoundationOne CDx utilizes FFPE tissue and analyzes 324 genes as well as genomic signatures. FoundationOne Liquid CDx analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes. The tests are companion diagnostics to identify patients who may benefit from treatment with specific therapies in accordance with the 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 tests 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 testing with FoundationOne CDx when archival tissue is not available which may pose a risk. When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, or for TEPMETKO® based on the detection of MET SNVs and indels that lead to MET exon 14 skipping, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing. Patients who are tested with FoundationOne Liquid CDx and 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 important risk information, please visit www.F1CDxLabel.com and www.F1LCDxLabel.com.