Osimertinib (TAGRISSO™) and the cobas® EGFR Mutation Test v2

Suzanne Jenkins, Darren Cross, Sidney A. Scudder

Research output: Chapter in Book/Report/Conference proceedingChapter

1 Scopus citations


Osimertinib (TAGRISSO) is an irreversible epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, selective for sensitizing and resistance mutations in the receptor. It was initially developed for second and later line use in patients whose disease had progressed on an earlier generation inhibitor due to the acquisition of the T790M resistance mutation. To identify patients whose tumor had acquired T790M-positive resistance, a companion diagnostic was codeveloped alongside the small molecule. The Roche cobas EGFR Mutation Test v2 was developed and clinical utility of T790M mutation detection was demonstrated for osimertinib; the test was initially approved for use with formalin-fixed paraffin-embedded tissue and later with circulating tumor DNA (ctDNA) from plasma samples. Several challenges were overcome to enable simultaneous FDA approval of the companion diagnostic and the new drug application as well as the approval of a plasma ctDNA-based companion diagnostic the following year; these are discussed.

Original languageEnglish (US)
Title of host publicationCompanion and Complementary Diagnostics
Subtitle of host publicationFrom Biomarker Discovery to Clinical Implementation
Number of pages15
ISBN (Electronic)9780128135396
ISBN (Print)9780128135402
StatePublished - Jan 1 2019
Externally publishedYes


  • Cobas®
  • Egfr
  • Egfr mutation test v2
  • Nsclc
  • Osimertinib
  • T790m
  • Tagrisso

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology, Toxicology and Pharmaceutics(all)


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