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Our Proven Portfolio. That’s Our Foundation.

Our comprehensive genomic profiling tests provide information about clinically relevant biomarkers and genomic alterations to help match patients to approved targeted therapies, immunotherapies, and clinical trial options—giving physicians and patients powerful actionable insights for navigating cancer care. 

FDA-approved tissue AND blood-based testing is available for all solid tumors with FoundationOne®CDx and FoundationOne®Liquid CDx. In addition, FoundationOne®Heme is a laboratory developed test for hematologic malignancies, sarcomas, or solid tumors where fusion detection is desired. There is also the option to add on immunohistochemistry (IHC) testing.

Compare Our Tests

Our Testing Portfolio

Compare FoundationOne®CDx FoundationOne®Liquid CDx FoundationOne®Heme

Overview

FDA-approved tissue-based companion diagnostic for all solid tumors, indicated for 20+ targeted therapies

View CDx Indications

FDA-approved blood-based companion diagnostic for all solid tumors, indicated for 4 targeted therapies

View CDx Indications

A laboratory developed test for hematologic malignancies, sarcomas or solid tumors where known or novel gene fusion detection is desired

Cancer Type

All Solid Tumors

All Solid Tumors

Hematologic Malignancies, Sarcomas, and Solid Tumors where known or novel gene fusion detection is desired

Typical Turnaround Time

<2 weeks from receipt of specimen

<2 weeks from receipt of specimen

2 weeks from receipt of specimen

Number of Genes Analyzed

324 (DNA)

324 genes (DNA)*

406 genes (DNA), 265 genes (RNA)

Specimen Collection Kit

FoundationOne CDx Specimen Shipping Kit - Orange Box FoundationOne Liquid CDx Specimen Shipping Kit - Dark Slate Box FoundationOne Heme Specimen Shipping Kits - Light Orange and Yellow Kits

Specimen Type

FFPE Tissue

View Specimen Instructions

Peripheral Whole Blood

View Specimen Instructions

FFPE Tissue, Bone Marrow Aspirate, Peripheral Whole Blood

View Specimen Instructions

Tumor Mutational Burden (TMB)

Microsatellite Instability (MSI)†

IHC Testing

  • Programmed death-ligand 1 (PD-L1) available as an optional add-on test

  • FDA-approved CDx for 2 immunotherapies in specific solid tumors 

  • Specimen Type: FFPE Tissue – 4 USS 

  • Typical Turnaround Time: 5 days from receipt of specimen

  • Programmed death-ligand 1 (PD-L1) available as an optional add-on test

  • FDA-approved CDx for 2 immunotherapies in specific solid tumors 

  • Specimen Type: FFPE Tissue – 4 USS 

  • Typical Turnaround Time: 5 days from receipt of specimen

  • Programmed death-ligand 1 (PD-L1) available as an optional add-on test

  • FDA-approved CDx for 2 immunotherapies in specific solid tumors 

  • Specimen Type: FFPE Tissue – 4 USS 

  • Typical Turnaround Time: 5 days from receipt of specimen

Additional Notes

  • Results include loss of heterozygosity (LOH) for ovarian cancer patients

  • National coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.

  • National coverage for qualifying Medicare and Medicare Advantage patients across all solid tumors.

*FoundationOne Liquid CDx is FDA-approved to report substitutions and inDels in 311 genes, including rearrangements and copy number losses only in BRCA1/2. Comprehensive results across all 324 genes, including bTMB, MSI-H status, and tumor fraction are reported in the professional services section of the report. 

Details

About FoundationOne®CDx About FoundationOne®Liquid CDx About FoundationOne®Heme

Compare By Gene

Compare Our Tests By Gene

Our proven portfolio of comprehensive genomic profiling tests analyzes hundreds of genes to help identify potential treatment options for your patients. Use the table below to compare gene coverage by test. You can search across the genes we cover by using the orange “Add a Gene” button.

Additional Notes

*TERC is non-coding RNA gene. **TERT is gene with promoter region.

†MSI status will be reported for FoundationOne Liquid CDx samples determined to have high microsatellite instability.

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

FoundationOne Heme was developed and its performance characteristics determined by Foundation Medicine. It has not been cleared or approved by the U.S. Food and Drug Administration. For more information on this laboratory developed test please see the Technical Specifications at foundationmedicine.com/f1h.

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.