Epidermal Growth Factor Receptor (EGFR) Mutation, Cobas V2, Solid Tumor

94719

Formalin-fixed, paraffin-embedded tissue block

1 block • 5 slides

10 unstained, 5-micron slides submitted in a slide holder AND 10 H&E slides submitted in a slide holder

Only NSCLC FFPET sections of 5-micron thickness containing at least 10% tumor content by area are to be used in the Cobas® EGFR test. Any sample containing less than 10% tumor content by area should be macro-dissected after deparaffinization

Room temperature

Formalin-fixed, paraffin-embedded tissue
Room temperature: 1 year
Refrigerated: Unacceptable
Frozen: Unacceptable

Slides
Room temperature: 60 days
Refrigerated: Unacceptable
Frozen: Unacceptable

Baked slides

Tuesday, Thursday, Saturday Morning Report available: 3 Days

Not detected

Activating mutations in the gene encoding EGFR occur primarily in NSCLC, and result in constitutive activation of the kinase activity of the EGFR protein, thereby contributing to the oncogenic process. The most common EGFR mutations in NSCLC include a variety of deletions in exon 19 and the substitution mutation L858R in exon 21; these mutations collectively constitute approximately 85% of EGFR mutations observed in NSCLC. The Cobas® EGFR Mutation Test v2 (Cobas® EGFR Test) is a real-time PCR assay designed to detect G719X substitution mutations in exon 18, deletion mutations in exon 19, T790M and S768I substitution mutations in exon 20, insertion mutations in exon 20, and L858R and L861Q substitution mutations in exon 21 in non-small cell lung cancer (NSCLC) patients. Defined EGFR mutations are detected using DNA isolated from formalin- fixed paraffin-embedded tumor tissue (FFPET) or circulating tumor DNA (cfDNA) from plasma derived from EDTA anti- coagulated peripheral whole blood.

The test is indicated as a companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed below in accordance with the approved therapeutic product labeling:
TARCEVA (erlotinib) for Exon 19 deletions and L858R in FFPET and plasma. TAGRISSO (osimertinib) for T790M in FFPET; no indications for plasma

Patients with positive Cobas® EGFR Mutation Test v2 test results using plasma specimens for the presence of EGFR exon 19 deletions or L858R mutations are eligible for treatment with TARCEVA® (erlotinib). Patients who are negative for these mutations by this test should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type.

The Cobas® EGFR Mutation Test v2 is indicated as an FDA approved companion diagnostic to aid in selecting NSCLC patients for treatment with the targeted therapies listed below:

TARCEVA® (erlotinib)
FFPET and plasma: Exon 19 deletions and L858R

TAGRISSO® (osimertinib)
FFPET and plasma: Exon 19 deletions, L858R and T790M

IRESSA® (gefitinib)
FFPET and plasma: Exon 19 deletions and L858R