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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.†
Test Features
Indications
Companion Diagnostic Indications
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 |
Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) |
|
MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping |
Tabrecta® (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) |
|
MSI-H |
Keytruda® (pembrolizumab) |
FAQ and Resources
FoundationOne CDx Resources
Resources
View Additional Resources-
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
Press ReleaseFoundation 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.
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
†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 Liquid CDx reports on bTMB
¶ FoundationOne Liquid CDx only reports MSI when determined to be high
# 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.