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.†
FoundationOne®CDx
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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. Foundation Medicine’s test portfolio enables you to easily reflex FoundationOne CDx, a tissue-based test, to FoundationOne®Liquid CDx, a blood-based test, or vice versa.‡
Coverage includes:
- National coverage for qualifying Medicare1 and Medicare Advantage2 patients across all solid tumors.3
- 80 commercial health plans cover one or more Foundation Medicine tests.
87% -- or nearly 9 out of 10 patients -- pay $0 for testing.4
Test Features
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All Solid Tumors
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20+ FDA-approved targeted therapies and 3 group claims§
Proven to help predict patient benefit across multiple targeted therapies in multiple cancer indications with over 20 FDA-approved CDx indications and 3 group claims§:
- Non-Small Cell Lung Cancer (NSCLC): EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA§ for EGFR exon 19 deletions and EGFR exon 21 L858R alterations
- Melanoma: BRAF Inhibitors approved by FDA§ for BRAF V600E
- Melanoma: BRAF/MEK Inhibitor Combinations approved by FDA§ for BRAF V600E and V600K
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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
| Biomarkers | FDA-Approved Therapy§ |
|---|---|
| EGFR exon 19 deletions & EGFR exon 21 L858R alterations | EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA§ |
| EGFR exon 20 T790M alterations | Tagrisso® (osimertinib) |
| ALK rearrangements | Alecensa® (alectinib), Alunbrig® (brigatinib) Xalkori® (crizotinib), or Zykadia® (ceritinib) |
| BRAF V600E | Braftovi® (encorafenib) in combination with Mektovi® (binimetinib). Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) |
| MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping | Tabrecta® (capmatinib) |
| ROS1 fusions | Rozlytrek® (entrectinib) |
| 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§ |
| BRAF V600 mutation-positive | Tecentriq® (atezolizumab) in combination with Cotellic® (cobimetinib) and Zelboraf® (vemurafenib) |
| 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) |
| 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) |
| BRCA1, BRCA2 alterations | Akeega® (niraparib + abiraterone acetate) |
| Biomarkers | FDA-Approved Therapy§ |
|---|---|
| MSI-High | Keytruda® (pembrolizumab) |
| TMB ≥ 10 mutations per megabase | Keytruda® (pembrolizumab) |
| NTRK1/2/3 fusions | Rozlytrek® (entrectinib), Vitrakvi® (larotrectinib) |
| RET fusions | Retevmo® (selpercatinib) |
FAQ and Resources
FoundationOne®CDx Resources
Resources
- Test Requisition Form (TRF)
- Test Requisition Form Explained
- FoundationOne CDx Technical Specifications (Gene List)
- FoundationOne CDx Specimen Instructions
- FoundationOne CDx Product Features
- Medicare ABN
- ABN Decision Tree (Solid Tumors)
- FoundationOne CDx Technical Information (FDA Label)
Press Release
Foundation Medicine and Natera Announce the Launch of FoundationOne®Tracker Personalized Circulating Tumor DNA Monitoring Assay for Investigational Use and Early Access Clinical Use
Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, and Natera, Inc., a global leader in cell-free DNA testing, today launched an early access program for clinical use of FoundationOne®Tracker, a personalized circulating tumor DNA (ctDNA) monitoring assay. In addition, the investigational use only version of the test is now available for use in clinical trials.
We Have Even More to Offer
Learn more about our comprehensive genomic profiling tests or explore our solutions for clinical development and companion diagnostics (CDx) or access and commercialization.
Questions? We’re Here to Help
Please contact our client services team by phone at
+1(888) 988-3639 or by email at the link below.
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
‡ When “Portfolio Reflex” is selected on the test requisition form (TRF), Foundation Medicine will proceed with the initial test and if the specimen does not meet the criteria for successful testing, we will automatically reflex to the other test and procure a new specimen.
¶ Loss of Heterozygosity (LOH) status reported for ovarian cancer only § 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#Group_Labeling
1. Medicare administered by federal government.
2. Medicare administered by private insurers.
3. For FoundationOne®CDx and FoundationOne®Liquid CDx, see “Decision for Next Generation Sequencing (NGS) for Medicare Beneficiaries with Advanced cancer –CAG-00450R.” (See Appendix B) available in the Medicare Coverage Database, https://www.cms.gov/medicare-coverage-database/new-search/search.aspx.
4. Data on File, Foundation Medicine, Inc., 2022. Based on US settled claims from 1/1/21 to 3/31/22 for all CGP and IHC tests offered by Foundation Medicine and reported during that time before considering any financial assistance. 64% of commercially insured and 97% of Medicare and Medicare Advantage patients had a $0 financial responsibility for Foundation Medicine testing. Some patients may have higher financial responsibility.
5. From specimen receipt to report
*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. Piqray® is a registered trademark of Novartis AG. Pemazyre™ is a trademark of Incyte. Tabrecta™ is a trademark of Novartis. KEYTRUDA® is a registered trademark of Merck.
Important Safety Information
FoundationOne CDx
FoundationOne®CDx is a qualitative next-generation sequencing based in vitro diagnostic test for 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 Tracker
FoundationOne®Tracker is a clinical test performed exclusively as a laboratory service. This test has not been cleared or approved by the U.S. Food and Drug Administration (FDA). FoundationOne Tracker is a personalized assay for oncology that is based on patient-specific somatic variants (substitutions and short insertions/deletions) identified from baseline tumor tissue testing and used to detect and longitudinally measure plasma circulating tumor DNA (ctDNA) abundance as a biomarker for tumor burden. Treatment decisions are the responsibility of the treating physician. ctDNA detection sensitivity may be limited if blood collection occurs within two weeks of surgery or while a patient is on therapy. A negative test result does not definitively indicate the absence of cancer. This test is not designed to detect or report germline variation, nor does it infer hereditary cancer risk for a patient. This test is designed to detect ctDNA from the assayed tumor only; new primary tumors will not be detected. This test is expected to have limited sensitivity in some cancer types due to limited ctDNA shed.
FoundationOne Liquid CDX
FoundationOne®Liquid CDx is for prescription use only and is a qualitative next-generation sequencing based in vitro diagnostic test for 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. When considering eligibility for certain therapies for which FoundationOne Liquid CDx is a companion diagnostic, testing of plasma is only appropriate where tumor tissue is not available. Patients who 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 complete risk information, please visit www.F1LCDxLabel.com.