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 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.‡
- 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
All Solid Tumors
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
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.
Companion Diagnostic Indications
|EGFR exon 19 deletions & EGFR exon 21 L858R alterations
|EGFR Tyrosine Kinase Inhibitors (TKI) approved by FDA§
|EGFR exon 20 T790M alterations
|Alecensa® (alectinib), Alunbrig® (brigatinib) Xalkori® (crizotinib), or Zykadia® (ceritinib)
|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
|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)
|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
|AKT1 E17K; PIK3CA R88Q, N345K, C420R, E542K, E545A, E545D, E545Q, E545K, E545G, Q546E, Q546K, Q546R, Q546P, M1043V, M1043I, H1047Y, H1047R, H1047L, and G1049R; and PTEN alterations
|Truqap™ (capivasertib) in combination with Faslodex® (fulvestrant)
|KRAS wild-type (absence of mutations in codons 12 and 13)
|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)
|FGFR2 fusions and select rearrangements
|Pemazyre® (pemigatinib) or TruseltiqTM (infigratinib)
|Homologous Recombination Repair (HRR) gene (BRCA1, BRCA2, ATM, BARD1, BRIP1, CDK12, CHEK1, CHEK2, FANCL, PALB2, RAD51B, RAD51C, RAD51D and RAD54L) alterations
|BRCA1, BRCA2 alterations
|Akeega® (niraparib + abiraterone acetate)
|TMB ≥ 10 mutations per megabase
|Rozlytrek® (entrectinib), Vitrakvi® (larotrectinib)
Foundation Medicine and Natera Announce the Launch of FoundationOne®Tracker Personalized Circulating Tumor DNA Monitoring Assay for Investigational Use and Early Access Clinical Use
We Have Even More to Offer
# 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
*Cotellic®, Herceptin®, Kadcyla®, Perjeta®, Rozyltrek® , Tecentriq® and Zelboraf® are registered trademarks of Genentech, Inc. Faslodex®, Lynparza®, Tagrisso®, and Truqap™ 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. Retevmo® is a registered trademark owned or licensed by Eli Lilly and Company. 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. 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. Exkivity® and Alunbrig® are a registered trademark of Takeda Pharmaceuticals International AG. Vitrakvi® is a registered trademark of Bayer Healthcare Pharmaceuticals Inc. Braftovi® is a registered trademark of Pfizer Inc. Mektovi® is a registered trademark of Array BioPharma Inc. Akeega® is a trademark of Janssen Biotech, Inc.
Important Safety Information
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 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.