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Test Name:
Epidermal Growth Factor Receptor (EGFR) Mutation Detection, by PCR and Fragment Analysis
- SBMF No:
44905 - Performance Lab Name:
ARUP Laboratories - Test Mnemonic:
EGFR PCR - ABN:
Required – Not FDA-Approved - CPT Code:
83892; 83896x2; 83898x2; 83907; 83909; 83912; 88381 - LOINC Code:
21665-5 - Ref Lab Test No:
2002440 - Also Known As:
ERBB1
Erlotinib Responsiveness in NSCLC, EGFR Mutation Analysis
Gefitinib Responsiveness in NSCLC, EGFR Mutation Analysis
IRESSA Responsiveness in NSCLC, EGFR Mutation Analysis
NSCLC or Non Small-cell Lung Cancer
Tarceva Responsiveness in NSCLC, EGFR Mutation Analysis - Spec Type:
Tumor tissue - Spec Container:
Paraffin-embedded, formalin-fixed tissue block - Pref Vol:
One block or 5 unstained 5 micron slides - Min Vol:
3 slides - Spec Collect:
Collected by physician - Spec Process:
Formalin fix (10% neutral buffered formalin) and paraffin embed tissue. Transport tissue block or unstained 5 micron slides. - Spec Store Transport:
Room temperature or refrigerated
Protect paraffin block from excessive heat
Ship in cooled container during summer months - Spec Stability:
Room temperature (20-20°C): Indefinitely
Refrigerated (2-8°C): Indefinitely
Frozen (-20°C): Unacceptable - Spec Reject:
No tumor in tissue
Frozen specimen
Specimen fixed/processed in alternative fixative (alcohol, Prefer®) or heavy metal fixatives (B-4 or B-5)
Decalcified specimens - Spec Remarks:
Include surgical pathology report - Methodology:
Polymerase Chain Reaction (PCR)
Fragment Analysis - Clinical Significance:
Refer to:
- Reference Range:
By report
Note:
This test is designed to detect exon 19 deletions and the exon 21 L858R point mutation. These mutations account for about 90 percent of all reported EGFR mutations. - Additional Test Info:
This test is performed pursuant to an agreement with Roche Molecular Systems, Inc.
This test was developed and its performance characteristics determined by ARUP Laboratories. The U.S. Food and Drug Administration has not approved or cleared this test; however, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.
- Day Run:
Sun-Sat (daily) - Time Reported:
11-13 days - Test Type:
GENETIC
