Molecular Pathology Laboratory Network

UGT1A1 Genotyping

Test Code
UGT1A1
Test Synonyms
Irinotecan toxicity
Associations
Metastatic colorectal cancer
Methodology
Invader® Third Wave Technologies
CPT Codes
83891 – Molecular isolation
83892 x8 – Enzymatic digestion
83896 x12 – Nucleic acid probe, each
83903 x4 – Mutation scanning
83908 x4 – Amplification each sequence
83912 – Interpretation and report
Turnaround Time
2-3 days
Specimen Requirements
5.0 mL (min. 3.0 mL) whole blood EDTA, ACD accepted.
Specimen Stability
  • Stable at 18°-25°C for 24 hours
  • Stable 4°C for up to 4 days
    • Storage & Handling
  • Ship at ambient temperature
  • If shipment delayed, store at 2–8°C, and ship with ice pack (Do not allow ice pack to directly contact sample)
    • Causes for Rejection
    Clotted specimen; Specimen exposed to extreme temperature; Anticoagulant toxic to cells; Insufficient number of cells
    Reference Range
    UGT1A1 *28 allele detected/not detected
    Related Content
    • CellSearch CTC Assay
    • KRAS Mutation analysis
    • BRAF Mutation analysis
    • Microsatellite Instability by IHC
    • p53 by IHC
    • CA 27-29 by chemiluminescence
    • CEA by chemiluminescence
    Description
    This test is indicated for patients with metastatic carcinoma of the colon or rectum who are candidates for first-line chemotherapy with CAMPTOSAR® (irinotecan) to assist with the identification of those patients who may be at risk for therapy-related toxicity.
    References
    1. Food and Drug Administration; Background document on UGT1A1 polymorphisms and irinotecan toxicity
    2. Innocenti F et al. (2004). Genetic variants in the UDP-glucuronasyltransferase 1A1 gene predict the risk of severe neutropenia of irinotecan. J Clin Oncol. 22(8):1382-1388.
    Trademarks
    Invader is a registered trademark of Third Wave Technologies, Inc., a wholly owned subsidiary of Hologic, Inc.
    Camptosar is a registered trademark of Pfizer.

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