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The FDA-approved tissue (324 genes) and blood genomic tests that serve as companion diagnostics for dozens of drugs.
FoundationOne CDx is Foundation Medicine's (Roche) tissue-based comprehensive genomic profiling test, using hybrid-capture next-generation sequencing of 324 genes to report mutations, copy-number changes, fusions, tumour mutational burden, microsatellite instability and homologous recombination deficiency by loss of heterozygosity; FoundationOne Liquid CDx applies the approach to circulating tumour DNA in blood. The tissue test was FDA-approved in 2017 and the liquid test in 2020. They are companion diagnostics for more than 30 therapies, including olaparib, capivasertib, trastuzumab deruxtecan for HER2-mutant NSCLC and selpercatinib, so one report can open several treatment doors at once. Tissue-blood concordance and unequal access remain issues. For a newcomer: a single sequencing test that tells an oncologist which targeted drugs a tumour might respond to.
Hybrid-capture NGS of 324 genes.
1.FFPE tumour DNA is extracted
Covered nationally under NCD 90.2 as an FDA-approved companion diagnostic NGS test for patients with recurrent, relapsed, refractory, metastatic or advanced stage III/IV cancer who have not previously had the same test for the same primary cancer. Laboratory tests under Part B have no coinsurance.
Most large commercial plans cover comprehensive genomic profiling for advanced NSCLC and increasingly for other advanced solid tumours, with prior authorisation; some limit panel size or require a specific lab.
No Part B coinsurance on clinical laboratory tests. Foundation Medicine offers a patient assistance programme for out-of-pocket costs.
Sources: Medicare.gov: Chemotherapy · Medicare.gov: Prescription drugs (outpatient, Part B) · CMS NCD 90.2: Next generation sequencing for patients with advanced cancer · Medicare.gov: Clinical laboratory tests. Not medical or financial advice; verify with your plan.
Sources: NICE search: FoundationOne CDx. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
Compare all products across the US, EU, UK, Japan, China and Australia →
FDA approval and parallel Medicare NCD: first FDA-approved broad CGP companion diagnostic source
TMB ≥10 mut/Mb companion claim for pembrolizumab source
FoundationOne Liquid CDx approved source
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Tissue CGP companion diagnostic (Liquid CDx 2020) |
| EU | 2019 | CE-IVD |
| Country | Reimbursement | List price | Assistance |
|---|---|---|---|
| United States | Medicare national coverage for FDA-approved CGP in advanced cancer (NCD 90.2); commercial coverage broad | ~$3,500 (Medicare CLFS rate for FoundationOne CDx) | - |
List prices are manufacturer or Medicare figures where publicly disclosed; net prices after rebates are usually lower. Reimbursement changes; check the payer.
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The proof that a blood test can split residual-disease patients into those likely to relapse and those likely cured, the premise of the ctDNA-guided adjuvant idea; no completed trial has yet acted on the result.
TMB-high is uncommon but not negligible in TNBC, rises at relapse, and the tumour-agnostic pembrolizumab indication makes it worth measuring on a metastatic biopsy.
One collection page on OnCo cites this paper by its DOI; this record gives the citation a page of its own so a reader can follow it without leaving OnCo. Read the abstract above alongside the citing page listed under Related; the record was created automatically from the Europe PMC entry and its figures have not been checked by hand.
It fixed the working numbers for a comprehensive panel in pancreatic cancer: a hit worth acting on in about one patient in six, most of it in repair genes and the KRAS wild-type minority.
It is the reference for what a colorectal molecular report must contain, and the document that turned extended RAS from a trial finding into a requirement.
Query for this drug: (TITLE:"FoundationOne CDx / Liquid CDx" OR ABSTRACT:"FoundationOne CDx / Liquid CDx") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about FoundationOne CDx / Liquid CDx, not a curated reading list.
Shares RET fusion and RET mutation, Tumour mutational burden testing, NTRK1/2/3 gene fusion, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment.
Shares Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO, RAS wild-type (extended KRAS and NRAS testing), Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics.
Shares Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO, RAS wild-type (extended KRAS and NRAS testing), MSI-high (microsatellite instability by PCR or sequencing), Companion diagnostics.
Shares Pathologists order genomic profiling automatically at diagnosis of advanced cancer, Overall survival in patients with pancreatic cancer receiving matched therapies following molecular profiling: a retrospective analysis of the Know Your Tumor registry trial, MET exon 14 skipping mutation, PIK3CA mutation.
Shares MET exon 14 skipping mutation, ROS1 fusion (ROS1-positive), RET fusion and RET mutation, ALK fusion (ALK-positive).
Shares EGFR exon 19 deletion, Guardant360 CDx, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics.
Shares ROS1 fusion (ROS1-positive), RET fusion and RET mutation, EGFR exon 19 deletion, Companion diagnostics.
Shares Molecular biomarkers for the evaluation of colorectal cancer: guideline from ASCP, CAP, AMP and ASCO, MSI and mismatch-repair testing, Companion diagnostics, Gallbladder cancer.