# cobas EGFR Mutation Test v2

Source: https://onco.cc/drugs/cobas-egfr-mutation-test/  
OnCo record `cobas-egfr-mutation-test` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

The lung cancer gene test that became the first blood-based companion diagnostic the FDA ever approved.

## Summary

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- Brand: cobas EGFR Mutation Test
- Modality: Real-time PCR companion diagnostic test (tissue and plasma)
- Mechanism: 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.
- Approvals: 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)

## Notes

- What a result means: an EGFR mutation makes an EGFR pill the first treatment; T790M after a first-generation pill points to osimertinib.

## Sources

- FDA PMA P150044: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P150044

## Connected records

- cancers: [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Liquid biopsy (ctDNA)](https://onco.cc/technologies/liquid-biopsy/)
- targets: [EGFR](https://onco.cc/targets/egfr/)
- drugs: [Erlotinib](https://onco.cc/drugs/erlotinib/), [Guardant360 CDx](https://onco.cc/drugs/guardant360-cdx/), [Osimertinib](https://onco.cc/drugs/osimertinib/)
- companies: [Roche / Genentech](https://onco.cc/companies/roche-genentech/)
- terms: [Circulating tumour DNA (ctDNA)](https://onco.cc/terms/ctdna/), [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/)
- roadmaps: [ctDNA tests roadmap: from a curiosity in plasma to blood tests that decide treatment](https://onco.cc/roadmaps/ctdna-tests/), [Diagnostics roadmap: stains → gene panels → blood tests that decide treatment](https://onco.cc/roadmaps/diagnostics-roadmap/)
- biomarkers: [EGFR exon 19 deletion](https://onco.cc/biomarkers/egfr-exon-19-deletion/), [EGFR L858R](https://onco.cc/biomarkers/egfr-l858r/), [EGFR T790M](https://onco.cc/biomarkers/egfr-t790m/)

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