Novel personalized medicine technology: UGT1A1 testing for irinotecan as a case study

Author:

Van Bebber Stephanie L1,Keegan Hugh L2,Phillips Kathryn A1,Issa Amalia M3

Affiliation:

1. University of California, Department of Clinical Pharmacy, School of Pharmacy, San Francisco, 3333 California St Suite 420 Box 0613, University of California, San Francisco, CA 94143–0613, USA.

2. Stanford University School of Medicine, Stanford, CA, USA. Keegan conducted this research while completing a joint MPH/MD program at the University of California, Berkeley, CA, USA.

3. The Methodist Hospital and University of Houston, Program in Personalized Medicine & Targeted Therapeutics and the Abramson Center for the Future of Health, 300 Technology Building, T2–309, Houston, TX 77204–4021, USA.

Abstract

Third Wave’s Invader® UDP glucuronosyltransferase 1A1 (UGT1A1) Molecular Assay, a genotyping system to predict adverse drug reactions in patients receiving the chemotherapeutic agent irinotecan (Camptosar®, Pzifer, NY, USA) for the treatment of metastatic colorectal cancer (mCRC), was recently approved by the US FDA. Clinical application, economic and regulatory data were collected on this test in the Evaluation Data for Assessing Personalized Medicine Translation (EDAPT) evidence base. This descriptive analysis highlight these data and the issues for the translation of this test to practice, including gaps in the evidence base, issues regarding adoption of the test to clinical practice and the potential societal impact of UGT1A1 testing for irinotecan prescribing.

Publisher

Future Medicine Ltd

Subject

Pharmacology,Molecular Medicine,General Medicine

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