The test is intended to be used to identify patients with advanced NSCLC whose tumors harbor mutations in exons 18, 19, 20 and 21 of the EGFR gene, and to select patients for treatment with small molecule tyrosine kinase inhibitors (TKIs) that target EGFR, and where the sample tumour content is low (i.e. less 30%). Sanger sequencing is currently still the method of choice for samples with tumour content of 30% or higher.
Paraffin embedded tissue block sent to the Histopathology Section. Alternatively, unstained slides can be sent to the Histopathology Section. At least 8 sections of 8 mm thickness, or 12 sections of 5 mm thickness for smaller biopsies should be sent together with one H&E slide, 4 mm thick with a coverslip as a reference slide. Tumour content must be indicated and must be at least 10%.
Real Time Allele-Specific Polymerase Chain Reaction (Roche cobas® EGFR Mutation Test V2)
Detected, Not Detected or Inconclusive
5 working days
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