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companiesCompany
Foundation Medicine (Roche)
Maker of the FDA-approved FoundationOne CDx genomic test used across dozens of drug labels.
Overview
Foundation Medicine, based in Boston and owned by Roche, makes FoundationOne CDx, the FDA-approved comprehensive genomic profiling test written into dozens of drug labels. Its products include FoundationOne CDx and Liquid CDx, FoundationOne Tracker for measurable residual disease and FoundationOne Heme, and with Flatiron Health it built the largest real-world clinico-genomic database, which OnCo carries as a collection. OnCo links it to comprehensive genomic profiling, liquid biopsy and digital twins, to cancer of unknown primary, and to bottlenecks on unvalidated biomarkers, data silos and weak real-world evidence, with ideas on a single calibrated tumour mutational burden and machine-readable genomic reports attached. Whether a test owned by a drug company can be trusted as a neutral companion diagnostic is the fair question. FoundationOne has its own page.
Headquarters
Boston, MA, US
Scorecard
All companies#285of 1244 companies, score 15
- approved products +6
- modalities +2
- regions +3
- registry trials +4
1 approved, 0 in phase 3, 0 earlier, 0 targets, 4 registry studies. Formula on the scorecards page.
Type
Website
ApprovedComprehensive genomic profiling test
The FDA-approved tissue (324 genes) and blood genomic tests that serve as companion diagnostics for dozens of drugs.
rctJAMA Oncology 2020257 citations
Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical Trial
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.
real worldJCO Precision Oncology 2019117 citations
Prospective comprehensive genomic profiling of 3,476 primary and metastatic prostate tumours
What a prostate cancer sequencing report looks like in practice, and the numerical basis for two clinical rules: do not expect checkpoint immunotherapy to work unless the tumour is mismatch repair deficient, and do not treat a CDK12 alteration as if it were a BRCA alteration.
translationalCancer 2016333 citations
Biliary cancer: utility of next-generation sequencing for clinical management
The clearest early head-to-head of the three biliary sites on one platform: for gallbladder cancer it made HER2 the target to test for and showed that IDH and FGFR inhibitors would rarely apply.
Similar pages
- CompanyTempus AI
Shares A global federated real-world evidence network at regulatory grade, Emulate combination trials from real-world data to triage which ones to run, Label every targetable mutation as truncal or branch on the report, A single calibrated tumour mutational burden across all sequencing panels.
- CompanyGuardant Health
Shares One open atlas of how tumours escape every drug, Drop mandatory fresh biopsies where blood or archival tissue would do, Label every targetable mutation as truncal or branch on the report, Every tumour sequencing report lists open, nearby, matched trials pulled live.
- TermMaster protocol (platform, basket and umbrella trials)
Shares I-PREDICT, WINTHER, Digital twins and virtual control arms, CUPISCO.
- PersonRazelle Kurzrock
Shares I-PREDICT, WINTHER, Comprehensive genomic profiling.
- CompanyCaris Life Sciences
Shares Every tumour sequencing report lists open, nearby, matched trials pulled live, Every tumour genomic report machine-readable and deposited nationally, Comprehensive genomic profiling.
- IdeaPathologists order genomic profiling automatically at diagnosis of advanced cancer
Shares FoundationOne CDx / Liquid CDx, Fragmented care and guideline gaps, Biomarkers are not validated or standardised, Comprehensive genomic profiling.
- IdeaTreat resistance like an infectious disease and run national surveillance
Shares Weak real-world evidence and registries, Data silos, Comprehensive genomic profiling, Liquid biopsy (ctDNA).
- InstitutionIntermountain Health Cancer Center
Shares Weak real-world evidence and registries, Data silos, Fragmented care and guideline gaps, Comprehensive genomic profiling.
cancers
fronts
technologies
drugs
ApprovedComprehensive genomic profiling test
companies
trials
roadmaps
ideas
A global federated real-world evidence network at regulatory gradeA single calibrated tumour mutational burden across all sequencing panelsDrop mandatory fresh biopsies where blood or archival tissue would doEmulate combination trials from real-world data to triage which ones to runEvery tumour genomic report machine-readable and deposited nationallyEvery tumour sequencing report lists open, nearby, matched trials pulled liveLabel every targetable mutation as truncal or branch on the reportOne open atlas of how tumours escape every drugRegulators recognise each other's companion diagnostic approvalsTest every man for DNA repair faults on the day his prostate cancer is found to have spread, not three treatments later
collections
bottlenecks
key papers
Association of Circulating Tumor DNA and Circulating Tumor Cells After Neoadjuvant Chemotherapy With Disease Recurrence in Patients With Triple-Negative Breast Cancer: Preplanned Secondary Analysis of the BRE12-158 Randomized Clinical TrialBiliary cancer: utility of next-generation sequencing for clinical managementProspective comprehensive genomic profiling of 3,476 primary and metastatic prostate tumours
Software in use
The software of oncology →Commercial and regulated products that this organisation sells. Each card says what is behind it: a regulator's database, the literature, a public body's list, or only the company's own words. Listing is not endorsement, and a clearance is a regulatory fact, not a clinical one.
A comprehensive genomic profiling test and the report software around it, approved as a companion diagnostic for a long and growing list of drugs.