Compare Our Tests | Foundation Medicine

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.

Our Testing Portfolio

Compare	FoundationOne®CDx	FoundationOne®Liquid CDx	FoundationOne®Heme
Overview	FDA-approved tissue-based companion diagnostic for all solid tumors, with 28 companion diagnostic (CDx) claims View CDx Indications	FDA-approved blood-based companion diagnostic for all solid tumors, with 9 companion diagnostic (CDx) claims 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
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

Select

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.