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Roche cobas® EGFR Mutation Test

PhenoPath is pleased to offer the Roche cobas® EGFR Mutation Test (v2), the only FDA-approved IVD assay for the detection of T790M, Exon 19 deletion, and L858R EGFR mutations in DNA isolated from formalin fixed paraffin embedded tumor tissue (FFPE) or in cell-free/circulating tumor DNA from plasma.

This test is indicated as a companion diagnostic to aid in selecting non-small cell lung carcinoma (NSCLC) patients 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 a subsequent line of treatment. 

The Roche cobas® assay uses qualitative real-time PCR to detect 42 clinically relevant mutations in exons 18, 19, 20, and 21 of the EGFR gene and can reliably identify mutations with a sensitivity of ~5% mutant allele in a background of wild-type DNA. 

Click here for a list of mutations included in the Roche cobas® EGFR Mutation Test (v2).

For more information about the FDA’s approval of the Roche cobas® EGFR Mutation test or the FDA’s approval of Tagrisso®, see www.cobasegfrtest.com and www.astrazeneca.com

Testing information:

Plasma samples
CPT Code: 81235
Turnaround Time: Within 3-5 business days of receipt
Specimen Requirements:
- Minimum of 2 mL of plasma (following collection instructions below)
- Recommend 4-6 mL of plasma for testing

Collection Instructions:
- Venipuncture into K2-EDTA/plasma separator tube (ideally collect two to three 5 mL tubes; minimum of one 5 mL tube needed)
- Within 4 hours of collection; separate plasma by centrifugation
- Transfer plasma into transport tube and freeze
- Immediately ship plasma to PhenoPath frozen on dry ice

FFPE samples
CPT code(s): 81235; 88381 may apply (reference only; CPTs may vary)
Turnaround time: 3-5 business days of receipt
Specimen Requirements:
- Formalin-fixed, paraffin-embedded (FFPE) tissue block (preferred) or unstained slides (10 slides are usually sufficient)

For more information about EGFR testing at Phenopath, including pricing and ordering information, please contact our Client Services department at 888-927-4366 or visit us at www.phenopath.com.