UGT1A1 Molecular Assay™

The FDA-cleared Invader^® UGT1A1 Molecular Assay is an in-vitro diagnostic test that detects two genetic polymorphisms in the UGT1A1 gene. The enzyme produced by UGT1A1 is responsible for the metabolism of irinotecan (Camptosar^®), a drug used in combination with standard chemotherapeutic agents in the first-line treatment of patients with metastatic colorectal cancer.

The active form of irinotecan is metabolized by the polymorphic enzyme UGT1A1. UGT1A1 activity is reduced in individuals with genetic polymorphisms that lead to reduced enzyme activity, such as the UGT1A1*28 polymorphism. Approximately 10% of the North American population is homozygous for the UGT1A1*28 allele. Patients with reduced UGT1A1 activity are at an increased risk of experiencing grade 4 neutropenia when treated with irinotecan.

The UGT1A1 Molecular Assay detects the *1 (TA6) and *28 (TA7) alleles of the UGT1A1 gene in genomic DNA. This test will help identify patients with a greater risk for irinotecan toxicity.

CPT Codes:

83891(1), 83892(8), 83896(12), 83908(4), 83912(1)

Specimen Requirements:

Peripheral Blood:

• 5 ml in potassium EDTA (lavender-top) tube.
• Refrigerate specimen. Use cold pack for transport. Be sure cold pack is not in direct contact with specimen during transport.
• Sample must be submitted in less than 5 days from patient draw date.

Turnaround Time:

4-5 days

Invader^® UGT1A1 Molecular Assay is a registered trademark of and manufactured and distributed by Third Wave Technologies, Inc., Madison, WI, USA.

Camptosar^® is a registered trademark of Yakult Honsha Co., LTD, licensed and distributed by Pfizer, Inc.

Client Services: Oncology/Pathology (800) 447-5816

Specimen Services/Pickup (877) 246-1226