FoundationOne CDx / Liquid CDx
The FDA-approved tissue (324 genes) and blood genomic tests that serve as companion diagnostics for dozens of drugs.
FoundationOne CDx and Liquid CDx are Foundation Medicine's (Roche) comprehensive genomic profiling tests. They report mutations, CNVs, fusions, TMB, MSI, and (tissue) HRD-LOH. Companion diagnostic for >30 therapies including olaparib, capivasertib, T-DXd (HER2 in NSCLC), and selpercatinib.
1.FFPE tumour DNA is extracted
- Medicare
- Part B (clinician-administered)NCD 90.2
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.
- Commercial insurance
- variable
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.
- Assistance programmes
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.
- Notes
- NHS England does not commission commercial CGP panels routinely; tumour profiling is delivered by the seven NHS Genomic Laboratory Hubs under the National Genomic Test Directory, including whole genome sequencing for some cancers. Commercial panels may be obtained privately.
- NHS England
- Not routinely funded
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 →
- 30 Nov 2017ApprovalUS
FDA approval and parallel Medicare NCD: first FDA-approved broad CGP companion diagnostic source
- Jun 2020Label changeUS
TMB ≥10 mut/Mb companion claim for pembrolizumab source
- 26 Aug 2020ApprovalUS
FoundationOne Liquid CDx approved source
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Tissue CGP companion diagnostic (Liquid CDx 2020) |
| 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.
Trials
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Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- IdeaDrop mandatory fresh biopsies where blood or archival tissue would do
Shares Foundation Medicine (Roche), Comprehensive genomic profiling, Liquid biopsy (ctDNA).
- IdeaLabel every targetable mutation as truncal or branch on the report
Shares Foundation Medicine (Roche), Biomarkers are not validated or standardised, Comprehensive genomic profiling.
- CompanyLabcorp
Shares Companion diagnostics, Comprehensive genomic profiling.
- IdeaA reliance pathway for companion diagnostics so the test arrives with the drug
Shares Companion diagnostics, Biomarkers are not validated or standardised.
- IdeaA commons for leftover trial biospecimens with standard access for approved research
Shares Companion diagnostics, Biomarkers are not validated or standardised, Liquid biopsy (ctDNA).
- IdeaStanding reflex biomarker panels per tumour type, run without an oncologist's order
Shares Pathologists order genomic profiling automatically at diagnosis of advanced cancer, Biomarkers are not validated or standardised.
- TermBiopsy
Shares Genomic profiling, Comprehensive genomic profiling, Liquid biopsy (ctDNA).
- TermCompanion diagnostic
Shares Regulators recognise each other's companion diagnostic approvals, Genomic profiling, Companion diagnostics, Biomarkers are not validated or standardised.