FoundationOne®Liquid CDx is an FDA-approved companion diagnostic that analyzes guideline-recommended genes from a simple blood draw. It is the only FDA-approved blood-based test to analyze over 300 genes**—making it the most comprehensive FDA-approved liquid biopsy on the market. Plus, as a professional service, which has not been reviewed or approved by the FDA, this test reports blood tumor mutational burden (bTMB), microsatellite instability high (MSI-H), and tumor fraction values1.
With targeted therapy options, comprehensive genomic profiling with FoundationOne Liquid CDx can help guide treatment strategies and help predict patient benefit across multiple cancer indications. Foundation Medicine’s test portfolio enables you to easily reflex FoundationOne Liquid CDx, a blood-based test, to FoundationOne®CDx, a tissue-based test, or vice versa.‡
Coverage includes:
With such broad coverage, 87% -- or nearly 9 out of 10 patients -- pay $0 for testing.5
Over 300 genes, bTMB, and MSI-H1 Includes guideline-recommended genes and biomarkers to help guide therapy selection and identify clinical trial options for patients with solid tumors.
1bTMB, MSI-H status, and tumor fraction are reported as a laboratory professional service which is not reviewed or approved by the FDA.
Requires only two 8.5mL tubes of blood to identify targeted therapy, immunotherapy, and clinical trial options.
| Biomarker(s) Detected | FDA-Approved Therapy* |
|---|---|
| ALK rearrangements | ALECENSA® (alectinib) |
| BRAF V600E | Braftovi® (encorafenib) in combination with Mektovi® (binimetinib) |
| EGFR exon 19 deletions and EGFR exon 21 L858R substitution | EGFR tyrosine kinase inhibitors approved by FDA§ |
| MET single nucleotide variants (SNVs) and indels that lead to MET exon 14 skipping | TABRECTA® (capmatinib) |
| ROS1 fusions** | ROZLYTREK® (entrectinib) |
| Biomarker(s) Detected | FDA-Approved Therapy* |
|---|---|
| BRCA1, BRCA2, ATM alterations | LYNPARZA® (olaparib) |
| BRCA1, BRCA2 alterations | RUBRACA® (rucaparib) |
| Biomarker(s) Detected | FDA-Approved Therapy* |
|---|---|
| PIK3CA mutations C420R, E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and H1047L, H1047R, and H1047Y | PIQRAY® (alpelisib) |
| Biomarker(s) Detected | FDA-Approved Therapy* |
|---|---|
| NTRK1/2/3 fusions** | ROZLYTREK® (entrectinib) |
| Biomarker(s) Detected | FDA-Approved Therapy* |
|---|---|
| BRAF V600E alteration | BRAFTOVI® (encorafenib) in combination with cetuximab |
Learn more about the clinical utility of FoundationOne Liquid CDx in a number of cancer types.
View a FoundationOne Liquid CDx NSCLC sample report. This report shows results with an EGFR exon 21 L858R substitution detected.
Our portfolio of tests analyzes genes and biomarkers for relevant alterations in patients with NSCLC, including EGFR, ALK, ROS1, BRAF, NTRK, METex14, PD-L1† and genomic signatures like TMB.‡
It’s always been an ambitious concept: By analyzing a patient’s blood, doctors might better understand their individual cancer, and thus better pinpoint what treatment options may be most effective. But yesterday’s ambition has become today’s reality—we’re living in an exciting time for this kind of test, known as liquid biopsy.
Our portfolio of tests analyzes all guideline-recommended genes and biomarkers for relevant alterations in patients with prostate cancer including: BRCA1, BRCA2, ATM, PALB2, FANCA, RAD51D, CHEK2, CDK12, and genomic signatures like MSI.§
View a FoundationOne Liquid CDx prostate cancer sample report. This report shows results with a BRCA2 alteration detected.
Are negative liquid biopsy results reliable or uninformative?
FoundationOne Liquid CDx reports include Tumor Fraction (TF) as a professional service which has not been reviewed or approved by the FDA.
Tumor Fraction is a measurement of the level of ctDNA within a liquid biopsy sample.
When FoundationOne®Liquid CDx Tumor Fraction is not elevated and results are negative, reflexing to tissue may find actionable gene alterations (40% more actionable alterations in NSCLC6).
Next steps in patient care protocols tend to be more clear with positive results, however; when liquid biopsy results are negative, be better informed with Tumor Fraction.
Liquid biopsies require detectable ctDNA levels in peripheral blood samples to be able to identify actionable alterations. Tumor Fraction helps you understand how much ctDNA was in a sample, facilitating FoundationOne Liquid CDx report interpretation.
Foundation Medicine reports Tumor Fraction as a percentage when Tumor Fraction is 10% or greater.
Specimens with elevated Tumor Fraction have substantial circulating tumor DNA (ctDNA) content, and thus higher sensitivity for identifying genomic alterations. Such specimens are at lower risk of false negative results.
Elevated tumor fraction (≥10%) values mean that there is improved concordance with tissue testing.
When liquid biopsy (LBX) results are negative and tumor fraction is low (<10%) additional tissue CGP may uncover actionable findings.
Tumor Fraction Can Better Inform Tissue Reflex Decisions and Next Steps in Cancer Care7
Samples were analyzed and their Tumor Fraction measurements recorded. All samples were then reflexed to tissue testing to observe any additional actionable findings.
Distribution of FoundationOne®Liquid CDx Tumor Fraction and FoundationOne®Liquid Tumor Fraction for subset of driver negative liquid biopsy samples (n=46).
NSCLC Tissue biopsy found actionable alterations in 40% of samples with liquid biopsy with Tumor Fraction below 10%
When Tumor Fraction is not elevated, reflex tissue biopsy CGP detects driver alterations in 40% of cases.
NSCLC Tissue biopsy found no additional actionable findings for liquid biopsy samples with elevated Tumor Fraction (≥10%).
When Tumor Fraction is elevated (≥10%) additional actionable alterations were not observed in reflex tissue biopsy CGP.
Learn more about our other tests: FoundationOne®CDx and FoundationOne®Heme. You can also explore our decision support, report integration, and clinical research and trial matching services.
Our client services team is here to help, Monday through Friday 8AM – 8PM EST.
**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 are reported as a laboratory professional service which is not reviewed or approved by the FDA.
‡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.
# PPA - Positive Percent Agreement
1. bTMB, MSI-H status, and tumor fraction are reported as a laboratory professional service which is not reviewed or approved by the FDA.
2. Medicare administered by federal government.
3. Medicare administered by private insurers.
4. 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.
5. 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.
6. Husain H, Madison RW, Haberberger J, et al. P2.14-01 Clinical Utility of Reflex to Tissue-based Comprehensive Genomic Profiling (CGP) After Negative Liquid Biopsy (LBx) in NSCLC. J Thorac Oncol. 2022;17:9 (S156-S157).
7. Husain H, et al. Tumor Fraction Correlates With Detection of Actionable Variants Across > 23,000 Circulating Tumor DNA Samples. JCO Precis Oncol. 2022;6:e2200261. doi:10.1200/PO.22.00261
*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. Exkivity® is a registered trademark of Takeda Pharmaceuticals International AG. BRAFTOVI® is a registered trademark of Pfizer Inc.
§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
**Note: When considering eligibility for ROZLYTREK® based on the detection of NTRK1/2/3 and ROS1 fusions, testing using plasma specimens is only appropriate for patients for whom tumor tissue is not available for testing.
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.
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.