Students Research in Progress
Tuesday, November 14, 2023
08:30 AM–10:00 AM
Abstract
Introduction: Pharmacists are positioned to lead in using pharmacogenomic (PGx) tests for precision medicine. 23andMe, a direct-to-consumer (DTC) genetic testing company, has gained FDA approvals for PGx reports and their use for making CYP2C19 and SLCO1B1 genotype-guided adjustments for clopidogrel, citalopram and simvastatin. 23andMe is consistently seeking additional approvals. Healthcare professionals are largely unaware of these FDA approvals and lack adequate PGx knowledge to understand the report’s limitations. This report seeks to provide pharmacists with a model for patient counseling and prescriber consulting within the context of 23andMe genetic testing, considering current and future FDA approvals.
Research Question or Hypothesis: Educating pharmacists on the validity, FDA approvals, and limitations of 23andMe PGx reports allows appropriate prescriber consulting and patient counseling on their reports.
Study Design: Variant coverage was compared between 23andMe, Association for Molecular Pathology (AMP) Tier 1, and Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. Recommendations for adjustment to therapy for the reported phenotypes were compared. Appropriate current and future use of 23andMe PGx reports are described, reflecting the difference in phenotype reporting.
Methods: FDA-approved 23andMe test variants were obtained from the company’s website and confirmed by FDA website documentation. AMP Tier 1 and CPIC-recommended alleles were extracted from their corresponding websites. Tables were created to compare the variant coverage and differences in recommendations for phenotypes derived from tests with different allele coverage.
Results: Phenotype prediction comparison demonstrates how the 23andMe test accurately predicts phenotypes for the FDA-approved and specific alleles that could gain future approval. However, specific clinically meaningful alleles are not covered by the 23andMe test, which will not be valid for phenotype prediction and preventing the relevant PGx response.
Conclusion: Educating pharmacists about 23andMe PGx test FDA approvals and limitations will prepare pharmacists for appropriate prescriber consulting and patient counseling regarding their 23andMe test results.
Presenting Author
Jacob Awkal PharmD CandidateTexas Tech University Health Sciences Center School of Pharmacy
Authors
J. Shawn Jones PhD MS
Texas Tech University Health Sciences Center School of Pharmacy