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94718: Egfr Mutation, Cobas V2, Liquid Biopsy Print View
Specimen Source      
EGFR Result RT-PCR     
EGFR Comment      

PRIMARY
1 Plasma EDTA-Pink 4 (2) mL   Refrigerated - 72 Hour(s)/Frozen - 12 Month(s)  
ALTERNATE

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(R) (erlotinib) for Exon 19 deletions and L858R in FFPET and plasma TAGRISSO(TM) (osimertinib) for T790M in FFPET and 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) and those positive for T790M are eligible for treatment with TAGRISSO(TM) (osimertinib). Patients who are negative for these mutations should be reflexed to routine biopsy and testing for EGFR mutations with the FFPET sample type. *The efficacy of TAGRISSO(TM) (osimertinib) has not been established in the EGFR T790M plasma-positive, tissue-negative or unknown population and clinical data for T790M plasma-positive patients are limited; therefore testing using plasma specimens is most appropriate for consideration in patients from whom a tumor biopsy cannot be obtained.

Please submit a total of 4 mL plasma. Plasma should be separated
from blood within four hours of collection time. Shipping on dry
ice and maintaining at -70 degree C at all times is preferred.
Specimens may be shipped refrigerated if specimen can be maintained
refrigerated and will reach testing lab within 72 hours. Frozen at
-20 C specimens are not acceptable.
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
Preferred Specimen: 4 mL (2 mL minimum) plasma collected in two K2EDTA tubes

Transport Temperature: Frozen -70 degrees Celsius is preferred, refrigerated acceptable if received within 72 hours

Methodology: Real-Time Polymerase Chain Reaction






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