Our Proven Portfolio. That’s Our Foundation.
Our 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.
Our Testing Portfolio
| Compare | FoundationOne®CDx | FoundationOne®Liquid CDx | FoundationOne®Heme |
|---|---|---|---|
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Overview |
FDA-approved tissue-based companion diagnostic for all solid tumors, indicated for 20+ targeted therapies |
FDA-approved blood-based companion diagnostic for all solid tumors, indicated for 8 targeted therapies |
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 |
12 days or less from receipt of specimen |
10 days or less from receipt of specimen |
2 weeks from receipt of specimen |
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Number of Genes Analyzed |
324 (DNA) |
324 genes (DNA)* |
406 genes (DNA), 265 genes (RNA) |
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Specimen Collection Kit |
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Specimen Type |
FFPE Tissue |
Peripheral Whole Blood |
FFPE Tissue, Bone Marrow Aspirate, Peripheral Whole Blood |
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Tumor Mutational Burden (TMB) |
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Microsatellite Instability (MSI)† |
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Medicare Coverage‡ |
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IHC Testing |
Programmed death-ligand 1 (PD-L1) available as an optional add-on test. |
Programmed death-ligand 1 (PD-L1) available as an optional add-on test. |
Programmed death-ligand 1 (PD-L1) available as an optional add-on test. |
|
Additional Notes |
Results include loss of heterozygosity (LOH) for ovarian cancer patients |
*FoundationOne®Liquid CDx is FDA-approved to report substitutions and indels in 311 genes, including rearrangements in ALK and BRCA1/2 and copy number alterations in BRCA1/2 and ERBB2 (HER2). Comprehensive results across all 324 genes, including bTMB, MSI-H status, and tumor fraction are reported as a laboratory professional service which is not reviewed or approved by the FDA. †MSI status will be reported for FoundationOne Liquid CDx samples determined to have high microsatellite instability as a laboratory professional service which is not reviewed or approved by the FDA. |
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Details |
Compare Our Tests By Gene
Our proven portfolio of 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.
‡All Foundation Medicine tests are covered by Original Medicare and Medicare Advantage for qualifying beneficiaries
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
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.
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.