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EGFR_Roche cobas® EGFR Mutation Test (IVD) pin


Methodology: PCR

Clinical Significance:
The Roche cobas® EGFR Mutation Test v2 is an FDA-approved companion diagnostic for both first and second line therapy decisions for patients with non-small cell lung carcinoma (NSCLC). This assay is FDA approved for identifying NSCLC patients with EGFR exon 19 deletions and exon 21 (L858R) substitution mutations for whom treatment with Tarceva® (erlotinib) may be effective as a first line therapy; and for identifying NSCLC patients who harbor a T790M mutation, indicating eligibility for treatment with Tagrisso® (osimertinib) as second line therapy. Per the FDA news release of November 13, 2015, Tagrisso® (AZD9291) is the only approved medicine indicated for patients with metastatic EGFR T790M mutation-positive NSCLC who have progressed on or after EGFR tyrosine kinase inhibitor therapy. Effective Tuesday, November 17, 2015, the Roche cobas® EGFR Mutation Test v2 replaced PhenoPath’s prior EGFR mutation assay. The Roche cobas® assay similarly uses qualitative real-time PCR to detect clinically relevant mutations in exons 18, 19, 20, and 21 of the EGFR gene and provides improved sensitivity as only 5% mutant allele is needed for reliable mutation detection in a background of wild-type DNA. In addition, the cobas® EGFR assay covers a greater number of mutations, identifying 42 mutations in exons 18-21, as compared to the 21 mutations covered by PhenoPath’s prior assay.

Organ: Lung

Disease State: Mesothelioma vs. Adenocarcinoma

CPT Code(s): 81235; 88381 may apply (reference only; CPTs may vary)

Turnaround Time: Within 3-5 business days of receipt

Schedule: Tu, W, F

Specimen Requirements:
Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)