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94719: Egfr Mutation, Cobas V2, Solid Tumor Print View
Specimen Source      
Block/Specimen ID:      
EGFR Result RT-PCR     
EGFR Comment      

PRIMARY
1 Tissue Para Block-F.Fixed 1 (1) g   Room Temperature - 12 Month(s)  
ALTERNATE
  Micron Unstained Slides   Room Temperature - 60 Day(s)  
  H & E Slides   Room Temperature - 60 Day(s)  

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(R) EGFR Mutation Test v2 (Cobas(R) 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-free 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(R) 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(R) (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.

Only NSCLC FFPET sections of 5-micron thickness containing at least
10% tumor content by area are to be used in the Cobas(R) EGFR test.
Any sample containing less than 10% tumor content by area should be
macro-dissected after deparaffinization.
Setup Schedule
Tuesday, Thursday, Saturday

Reported (Analytical Time)
3 days

CPT Code
81235

The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

Notes
Reject Criteria: Baked slides Transport Temperature: Room temperature Methodology: Real-Time Polymerase Chain Reaction






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