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The lung cancer gene test that became the first blood-based companion diagnostic the FDA ever approved.
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.
Allele-specific real-time PCR for 42 EGFR mutations in exons 18 to 21, including L858R, exon 19 deletions and T790M, from tumour tissue or plasma cell-free DNA. Connects to EGFR.
1.cobas EGFR Mutation Test v2 slips into a pocket on EGFR.
Background: ADC sequencing, Antigen escape (antigen loss, lineage switch), BCG-unresponsive, Castration-resistant prostate cancer (CRPC), Circulating tumour DNA (ctDNA). Also on OnCo: Resistance: how tumours escape each drug class · Lines of therapy.
| 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) |
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Query 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.
Shares Companion diagnostics, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA), Non-small-cell lung cancer and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA) and the tag test.
Shares Companion diagnostic, EGFR exon 19 deletion, Companion diagnostics, EGFR and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment, Circulating tumour DNA (ctDNA), Liquid biopsy (ctDNA) and the tag test.
Shares Companion diagnostic, EGFR exon 19 deletion, Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, EGFR and the tag test.
Shares Companion diagnostics, Roche / Genentech, Non-small-cell lung cancer and the tag test.
Shares Diagnostics roadmap: stains → gene panels → blood tests that decide treatment, Companion diagnostics, Non-small-cell lung cancer and the tag test.