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

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.