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What is FoundationOne CDx?

FoundationOne CDx

FoundationOne CDx is the first FDA-approved tissue-based broad companion diagnostic (CDx) that is clinically and analytically validated for all 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.  

Test results include microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions, and loss of heterozygosity (LOH) for ovarian cancer patients. You can also order PD-L1 immunohistochemistry (IHC) testing* as an optional add-on test. We offer the option to reflex from FoundationOne CDx testing to FoundationOne®Liquid CDx if the tissue submitted does not meet the criteria for successful testing. 

FoundationOne CDx has national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.† 

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All Solid Tumors

A single test analyzes guideline-recommended genes in solid tumors, including companion diagnostic indications with a direct path to therapy. FoundationOne CDx also has national coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.†

20+ FDA-approved targeted therapies

The comprehensive platform includes genes and biomarkers associated with current FDA-approved therapies and others potentially relevant to future approvals.

Genomic Signatures

Results include MSI and TMB with the option to add PD-L1* testing to help inform immunotherapy decisions. Loss of Heterozygosity (LOH) is included in results for ovarian cancer patients.

Indications

Companion Diagnostic Indications

Indications

Biomarkers FDA-approved Therapy‡

EGFR exon 19 deletions & EGFR exon 21 L858R alterations

Gilotrif® (afatinib), Iressa® (gefitinib), Tagrisso® (osimertinib), or Tarceva® (erlotinib)

EGFR exon 20 T790M alterations

Tagrisso® (osimertinib)

ALK rearrangements

Alecensa® (alectinib), Alunbrig® (brigatinib)  Xalkori® (crizotinib), or Zykadia® (ceritinib)

BRAF V600E

Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib)

MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping

TabrectaTM (capmatinib)
Biomarkers FDA-approved Therapy‡

BRAF V600E

BRAF Inhibitors approved by FDA§

BRAF V600E or V600K

Mekinist® (trametinib) or BRAF/MEK Inhibitor Combinations approved by FDA§
Biomarkers FDA-approved Therapy‡

ERBB2 (HER2) amplification 

Herceptin® (trastuzumab), Kadcyla® (ado-trastuzumab-emtansine), or Perjeta® (pertuzumab)

PIK3CA C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R, H1047L, H1047R, and H1047Y alterations

Piqray® (alpelisib)
Biomarkers FDA-approved Therapy‡

KRAS wild-type (absence of mutations in codons 12 and 13)

Erbitux® (cetuximab)

KRAS wild-type (absence of mutations in exons 2, 3, and 4) and NRAS wild type (absence of mutations in exons 2, 3, and 4)

Vectibix® (panitumumab)
Biomarkers FDA-approved Therapy‡

BRCA1/2 alterations

Lynparza® (olaparib) or Rubraca® (rucaparib)
Biomarkers FDA-approved Therapy‡

FGFR2 fusions and select rearrangements

Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
Biomarkers FDA-approved Therapy‡

Homologous Recombination Repair (HRR) gene (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D and RAD54L) alterations

Lynparza® (olaparib)
Biomarkers FDA-Approved Therapy‡

TMB ≥ 10 mutations per megabase

Keytruda® (pembrolizumab)

NTRK1/2/3 fusions

Vitrakvi® (larotrectinib)

Real-life Results

Real-life Results

Learn more about the clinical utility of FoundationOne CDx in a number of cancer types. 

  • Sample Report

    NSCLC Sample Report

    View a FoundationOne CDx non-small cell lung cancer (NSCLC) sample report. This report shows an EGFR mutation and elevated TMB.

    Download Sample Report

  • NSCLC Profiler

    Uncovering Treatment Options for Patients with Non-Small Cell Lung Cancer (NSCLC)

    Our portfolio of tests analyzes genes and biomarkers for relevant alterations in patients with NSCLC, including EGFR, ALK, ROS1, BRAF, NTRK, MET, PD-L1* and genomic signatures like TMB.|

    Download NSCLC Profiler

  • Blog Post

    An End-to-end Approach to Precision Medicine: MET exon 14 Skipping Mutations in Non-small Cell Lung Cancer (NSCLC)

    FoundationOne CDx was approved to identify mutations that lead to MET exon 14 skipping in advanced non-small cell lung cancer (NSCLC) and match patients with a new targeted therapy, which was approved in parallel.

    Read the full blog post

  • Press Release

    Foundation Medicine and Dana-Farber Present Data at ASCO20 Showing that Comprehensive Genomic Profiling Identified Co-Occurring Alterations that May Cause Treatment Resistance in Patients with METex14-altered NSCLC

    Alterations that cause skipping of exon 14 on the MET gene (METex14) are drivers of a type of lung cancer with a poor prognosis, but that is treatable with a recently approved MET inhibitor.

    View full press release

  • SAMPLE REPORT

    Colorectal Cancer (CRC) Sample Report

    View a FoundationOne CDx CRC sample report. This report shows results with a KRAS alteration detected.

    Download Sample Report

  • COLORECTAL CANCER (CRC) PROFILER

    Uncovering Treatment Options for Patients with Colorectal Cancer

    Our portfolio of tests analyzes all guideline-recommended genes and biomarkers for relevant alterations in patients with CRC including KRAS, NRAS, BRAF, HER2, and genomic signatures like TMB and MSI.

    Download CRC Profiler

  • Publication

    Tumor Mutational Burden Is Predictive of Response to Immune Checkpoint Inhibitors in MSI-high Metastatic Colorectal Cancer

    PD-1 inhibitors in metastatic colorectal carcinoma (mCRC) with MSI-high (MSI-H) have demonstrated a high disease control rate and favorable progression-free survival (PFS); however, reported response rates to pembrolizumab and nivolumab are variable and often <50%, suggesting that additional predictive biomarkers are needed.

    View the Publication

  • Blog Post

    The Role of Comprehensive Genomic Profiling in Colorectal Cancer

    We’ve made incredible progress in CRC research, but there is more to be done to inform and enable access to precision medicine options for more patients. As we learn more about the biology of cancer, we are finding that the age-related differences in cancer drivers can be extremely important when it comes to finding the right treatment option.

    Read the Full Blog Post

  • Sample Report

    Prostate Cancer Sample Report

    View a FoundationOne CDx Prostate sample report. This report shows results with a BRCA2 alteration detected.

    Download Sample Report

  • PROSTATE PROFILER

    Unlocking New Treatment Options for Patients with Metastatic Prostate Cancer

    Our portfolio of tests analyzes all guideline-recommended genes and biomarkers for relevant alterations in patients with prostate cancer including: BRCA1, BRCA2, ATM, PALB2, FANCA, RAD51D, CHEK2, CDK12, and genomic signatures like MSI.

    Prostate Profiler

  • Press Release

    Foundation Medicine Receives FDA Approval for FoundationOne®CDx as the Companion Diagnostic for LYNPARZA® to Identify Patients with HRR-Mutated Metastatic Castration-Resistant Prostate Cancer

    FoundationOne®CDx is FDA-approved as the companion diagnostic for LYNPARZA® to identify patients with HRR-mutated metastatic castration-resistant prostate cancer

    Prostate Press Release

  • PUBLICATION

    Olaparib for Metastatic Castration-Resistant Prostate Cancer

    LYNPARZA® was approved based on positive results from the PROfound study for which Foundation Medicine served as the Next-Generation Sequencing (NGS) partner.

    View Publication

  • SAMPLE REPORT

    Breast Cancer Sample Report

    View a FoundationOne CDx breast cancer sample report. This report shows results with a PIK3CA alteration detected.

    Download Sample Report

  • BREAST CANCER PROFILER

    Unlocking new treatment options for Patients with Metastatic Breast Cancer

    Our portfolio of tests analyzes guideline-recommended genes for relevant alterations in patients with breast cancer including ERBB2 (HER2), BRCA1,# BRCA2,# and PIK3CA and offer a supplemental IHC-test for PD-L1.*

    DOWNLOAD BREAST CANCER PROFILER

  • BLOG POST

    Breast cancer – a very personal history and an even more personalized future

    Learn more about how comprehensive genomic profiling can impact treatment options for breast cancer patients, as our CEO Cindy Perettie reflects on data presented at the latest SABCS conference.

    READ FULL BLOG POST

  • PUBLICATION

    Comprehensive Genomic Sequencing and the Molecular Profiles of Clinically Advanced Breast Cancer

    Comprehensive genomic profiling (CGP) by NGS can reveal targetable, clinically relevant genomic alterations that can stratify tumors by predicted sensitivity to a variety of therapies, including HER2- or MTOR-targeted therapies, immunotherapies, and other kinase inhibitors.

    VIEW PUBLICATION

FAQ and Resources

FoundationOne CDx Resources

FAQs

View all Provider FAQs

Resources

View Additional Resources

We Have Even More to Offer

Learn more about our other tests: FoundationOne®Liquid CDx and FoundationOne®Heme. You can also explore our decision support, report integration, and clinical research and trial matching services. 

We’re Here to Help

Questions? Our Client Services team is on hand to help.

Contact Us

Additional Notes

*PD-L1 by Immunohistochemistry (IHC) can be ordered as a supplemental test and may inform eligibility for several immunotherapies across different cancer types

†Medicare and Medicare Advantage members have coverage of FoundationOne CDx in accordance with the Centers for Medicare and Medicaid Services (CMS) national coverage determination (NCD) criteria. 

‡ 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 AB Corporation. 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. Piqray® is a registered trademark of Novartis AG. TabrectaTM is a trademark of Novartis AG. PemazyreTM is a trademark of Incyte Holdings Corporation. Keytruda® is a registered trademark of Merck Sharp & Dohme Corp.

§ For the most current information about the therapeutic products in this group, go to: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools. FoundationOne CDx reports will include this indication by January 20th, 2022.

| FoundationOne Liquid CDx reports on bTMB as a laboratory professional service.

For FoundationOne Liquid CDx, MSI status will be reported for samples determined to have high microsatellite instability as a laboratory professional service.

# Foundation Medicine detects both somatic and germline alterations but does not differentiate between the two on reports.

Important Safety Information

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FoundationOne CDx

FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors and is for prescription use only. The test analyzes 324 genes as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) and is a companion diagnostic to identify patients who may benefit from treatment with specific therapies in accordance with the approved 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 test 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 the complete label, including companion diagnostic indications and important risk information, please visit www.F1CDxLabel.com. 

FoundationOne Liquid CDx

FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for advanced cancer patients with solid tumors. The test analyzes 324 genes utilizing circulating cell-free DNA and is FDA-approved to report short variants in 311 genes and as a companion diagnostic to identify patients who may benefit from treatment with specific therapies (listed in Table 1 of the Intended Use) in accordance with the approved 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 test does not guarantee a patient will be matched to a treatment. A negative result does not rule out the presence of an alteration. Patients who are negative for 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 complete risk information, please visit www.F1LCDxLabel.com.