Genomic Testing

FOUNDATIONONE CDx

The first FDA-approved broad companion diagnostic for solid tumors, including: NSCLC, Colorectal, Breast, Ovarian, and Melanoma
  • Cancer Type
    Solid Tumor
  • Sample Type
    FFPE
  • Results Expected
    <2 weeks**

What is FoundationOne CDx?

FoundationOne CDx is the first FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information — both to consider appropriate therapies for patients and understand results with evidence of resistance — based on the individual genomic profile of each patient’s cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. You can also order PD-L1 immunohistochemistry (IHC) testing to help inform your therapy decision.

FoundationOne CDx will be available to order in early 2018 upon completion of the Parallel Review process with FDA and CMS.

Overview

FoundationOne CDx

  • All

    solid tumors

  • 17

    FDA-approved targeted therapies

  • 2

    immunotherapy biomarkers

  1. A single test that looks for all guideline-recommended genes in solid tumors, including CDx indications with a direct path to therapy.
  2. Results include MSI and TMB with the option to add PD-L1 testing to help inform immunotherapy decisions.
  3. Comprehensive platform that can be updated regularly as more genes and genomic signatures are indicated for use with FDA-approved therapies.

Go Beyond FoundationOne®

F1CDx Analytical Validations

Now with Clinical Validation

FoundationOne CDx is the next evolution of FoundationOne®, our pioneering laboratory-developed test (LDT).

FoundationOne CDx is approved by the FDA and has been clinically and analytically validated with 9 times more samples and cell lines as compared with our analytical validation of FoundationOne.

Key Indicators

FDA-Approved Therapies

Real Life Results

Simplified test results provide clear information about companion diagnostic alterations and their associated targeted therapies. We also provide clinically significant alterations and available clinical trials specific to each patient’s cancer.

  1. FDA-Approved Therapies
    List of FDA-approved companion diagnostics to identify patients who may benefit from associated therapies
  2. Potential Resistance
    This section appears when patients may be resistant to therapy based on genomic profile
  3. All Other Biomarkers
    All other biomarkers, including TMB and MSI, without companion diagnostic claims
  4. Professional Services
    Interpretive content that can be used for patient management in accordance with professional guidelines in oncology
Genomic Testing Report

View a Sample FoundationONE CDx Report

Clinical Data Image

Clinical Data

In our clinical validation, FoundationOne CDx showed concordance with the following FDA-approved companion diagnostics and is approved to help identify patients that may benefit from associated therapies.

SUMMARY OF CLINICAL STUDIES

Interested in learning more about how a comprehensive genomic profiling (CGP) test might help your patient? Our publications can help.

View all Reports & Validation

The first FDA-approved broad companion diagnostic

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FoundationOne CDx provides comprehensive results with a FFPE tissue block or 10 slides (and 1 H&E slide) to save tissue and time compared to sequential single-marker tests.

Download Specimen Instructions

FoundationOne CDx Specimen Shipping Kit

Learn More

Discover how our next-generation sequencing (NGS) approach with FoundationOne CDx can make a difference.

Questions?
We’re here to help.

Call Foundation Medicine Client Services at (888) 988-3639 between 8:00 am ET and 8:00 pm ET, Monday through Friday. You can also send us an email and a representative will respond during regular business hours.

Contact Us

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*Tarceva® is the registered trademark of OSI Pharmaceuticals, LLC. Zelboraf®, Herceptin®, Perjeta®, Kadcyla®, and Cotellic® are registered trademarks of Genentech, Inc. Gilotrif® is a registered trademark of Boehringer Ingelheim International GmbH. Iressa® and Tagrisso® are registered trademarks of the AstraZeneca group of companies. Xalkori® is a registered trademark of Pfizer Inc. Zykadia®, Tafinlar®, and Mekinist® are registered trademarks of Novartis AG Corporation Switzerland. Erbitux® is a registered trademark of ImClone LLC, a wholly owned subsidiary of Eli Lilly and Company. Alecensa® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha. Vectibix® is a registered trademark of Immunex Corporation. Rubraca® is a registered trademark of Clovis Oncology, Inc.

**Typical turnaround time from receipt of specimen is <2weeks.

PD-L1 by Immunohistochemistry (IHC) can be ordered by selecting an additional test.