How to Transition from Single‐Gene Pharmacogenetic Testing to Preemptive Panel‐Based Testing: A Tutorial

Abstract

There have been significant advancements in precision medicine and approaches to medication selection based on pharmacogenetic results. With the availability of direct‐to‐consumer genetic testing and growing awareness of genetic interindividual variability, patient demand for more precise, individually tailored drug regimens is increasing. The University of Florida (UF) Health Precision Medicine Program (PMP) was established in 2011 to improve integration of genomic data into clinical practice. In the ensuing years, the UF Health PMP has successfully implemented several single‐gene tests to optimize the precision of medication prescribing across a variety of clinical settings. Most recently, the UF Health PMP launched a custom‐designed pharmacogenetic panel, including pharmacogenes relevant to supportive care medications commonly prescribed to patients undergoing chemotherapy treatment, referred to as “GatorPGx.” This tutorial provides guidance and information to institutions on how to transition from the implementation of single‐gene pharmacogenetic testing to a preemptive panel‐based testing approach. Here, we demonstrate application of the preemptive panel in the setting of an adult solid tumor oncology clinic. Importantly, the information included herein can be applied to other clinical practice settings.

Design and Early Implementation Successes and Challenges of a Pharmacogenetics Consult Clinic

“…In line with the value of panel-based pharmacogenetic testing, the development and implementation of the GatorPGx panel ( Table S1 ) was successful [ 34 ]. Our experience with ordering and utilizing the results has been positive; the panel enables us to provide guidance on additional medications, at a lower out-of-pocket cost to patients compared to the current cost for individual CYP2C19 and CYP2D6 testing.…”

“…After the sample was collected, a courier transferred it to the in-house College of American Pathologists (CAP)/CLIA-certified clinical laboratory (UF Health Pathology Laboratories, Gainesville, FL, USA), where it was processed and analyzed for CYP2C19 and/or CYP2D6 variants on separate platforms. Panel testing, which included CYP2C19 and CYP2D6, among 7 other pharmacogenes (i.e., GatorPGx panel [ 34 ]), became available from the laboratory in July 2019. Information on the laboratory, testing platforms, tested variants, and genotype translation are detailed in Table S1 .…”

The Changing Face of Oncology Research, Drug Development, and Clinical Practice: Toward Patient‐Focused Precision Therapeutics

“…Thus, much work remains to be able to optimally match therapies to a patient's specific tumor. 7 In addition, it is clear that a precision oncology approach will also need to incorporate a personalized medicine approach to supporting therapies 8 and an improved understanding of how commonly used medications impact tumor biology. 9…”

Clinical Pharmacology and Therapeutics: 2020 in Review

“…2 This was also the first example of an issue fully dedicated to a particular theme, including all original research articles. It also introduced the first CPT Tutorials, 3,4 a new article type for the journal providing practical educational material on tools, methodologies, and approaches in clinical pharmacology [5][6][7] ( Table 1).…”