Working Paper Article Version 1 This version is not peer-reviewed

Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients

Version 1 : Received: 18 April 2021 / Approved: 19 April 2021 / Online: 19 April 2021 (16:44:43 CEST)

How to cite: Niedrig, D.F.; Rahmany, A.; Heib, K.; Hatz, K.; Ludin, K.; Burden, A.M.; Béchir, M.; Serra, A.; Russmann, S. Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients. Preprints 2021, 2021040509 Niedrig, D.F.; Rahmany, A.; Heib, K.; Hatz, K.; Ludin, K.; Burden, A.M.; Béchir, M.; Serra, A.; Russmann, S. Clinical Relevance of a 16-Gene Pharmacogenetic Panel Test for Medication Management in a Cohort of 135 Patients. Preprints 2021, 2021040509

Abstract

There is a growing number of evidence-based indications for pharmacogenetic (PGx) testing. We aimed to evaluate clinical relevance of a 16-gene panel test for PGx-guided pharmacotherapy. In an observational cohort study we included subjects tested with a PGx panel for variants of ABCB1, COMT, CYP1A2, CYP2B6, CYP3A4, CYP3A5, CYP2C9, CYP2C19, CYP2D6, CYP4F2, DPYD, OPRM1, POR, SLCO1B1, TPMT and VKORC1. PGx-guided pharmacotherapy management was supported by the PGx expert system SONOGEN XP. The primary study outcome was PGx-based changes and recommendations regarding current and potential future medication. PGx-testing was triggered by specific drug-gene pairs in 102 subjects, and by screening in 33. Based on PharmGKB expert guidelines we identified at least one “actionable” variant in all 135 (100%) tested patients. Drugs that triggered PGx-testing were clopidogrel in 60, tamoxifen in 15, polypsychopharmacotherapy in 9, opioids in 7, and other in 11 patients. Among those, PGx variants resulted in clinical recommendations to change PGx-triggering drugs in 33 (32.4 %), and other current pharmacotherapy in 23 (22.5%). Additional costs of panel vs. single gene tests are moderate, and the efficiency of PGx panel testing challenges traditional cost-benefit calculations for single drug-gene pairs. However, PGx-guided pharmacotherapy requires specialized expert consultations with interdisciplinary collaborations.

Keywords

pharmacotherapy, pharmacogenetics, genetic panel tests, clinical relevance, CYP450, SONOGEN XP

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