cobas EGFR Mutation Test v2
The lung cancer gene test that became the first blood-based companion diagnostic the FDA ever approved.
Overview
Roche's cobas EGFR Mutation Test was approved in 2013 with erlotinib for EGFR-mutant non-small-cell lung cancer. Version 2 (PMA P150044, decision 28 September 2016 for the tissue claim; plasma claim granted in June 2016) added the T790M resistance mutation as the companion for osimertinib and, critically, allowed testing of plasma when tissue is unavailable, the first FDA-approved liquid biopsy companion diagnostic. Plasma sensitivity is lower than tissue, so a negative plasma result must be followed by tissue testing. The test is CE-marked and remains widely used where sequencing is not available.
- AmivantamabApproved
- CamizestrantApproved
- Comprehensive genomic profilingStandard of care
- Liquid biopsy (ctDNA)Standard of care
- LorlatinibApproved
- MRD / molecular residual disease testingEstablished
- ADC payload neutralisersPhase 1
- BGB-16673Phase 3
- Bispecific ADCPhase 3
- BRUIN CLL-321Positive
- CaDAnCe-304Recruiting
- CIRCULATE-Japan (GALAXY / VEGA / ALTAIR)Active
- A clone report from blood at every treatment cycle
- A fast route to the matched drug when it is licensed for another cancer
- A multi-cancer platform trial of adaptive (dose-holiday) therapy
- A national rapid research autopsy network for end-stage cancer
- A standard evolvability score for every tumour
- A standing platform trial that assigns treatment by how the tumour escaped
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance atlas: how tumours escape and what closes the route · Lines of therapy.
Approvals
| Region | Year | Indication |
|---|---|---|
| US | 2013 | EGFR exon 19 deletion / L858R companion diagnostic for erlotinib (v1) |
| US | 2016 | v2: T790M for osimertinib; plasma testing (first liquid biopsy companion diagnostic) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: an EGFR mutation makes an EGFR pill the first treatment; T790M after a first-generation pill points to osimertinib.
Latest papers
topQuery for this drug: (TITLE:"cobas EGFR Mutation Test v2" OR ABSTRACT:"cobas EGFR Mutation Test v2" OR TITLE:"cobas EGFR Mutation Test" OR ABSTRACT:"cobas EGFR Mutation Test") 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 cobas EGFR Mutation Test v2, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductResolution ctDx FIRST
Shares Companion diagnostics, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA), Non-small-cell lung cancer and the tag test.
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Shares Companion diagnostic, Companion diagnostics, EGFR, Non-small-cell lung cancer and the tag test.
- Producttherascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)
Shares Companion diagnostic, Companion diagnostics, EGFR, Non-small-cell lung cancer and the tag test.
- ProductVENTANA PD-L1 (SP263) Assay
Shares Companion diagnostics, Roche / Genentech, Non-small-cell lung cancer and the tag test.
- ProductGuardant Reveal
Shares Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA), Non-small-cell lung cancer and the tag test.
- ProductRaDaR
Shares Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA), Non-small-cell lung cancer and the tag test.
- ProductVENTANA PD-L1 (SP142) Assay
Shares Companion diagnostics, Roche / Genentech, Non-small-cell lung cancer and the tag test.
- ProductOncodetect
Shares Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA) and the tag test.