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Study Finds Incongruities Between Drug-Gene Associations Listed in FDA’s Table of Pharmacogenetic Associations and Guidelines Published by Clinical Pharmacogenetics Implementation Consortium (CPIC)


Bridging Inconsistencies May Encourage More Widespread Utilization of Hallmark Personalized Medicine Tests


WASHINGTON (March 30, 2022)

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A comparative analysis conducted by the Personalized Medicine Coalition and published today in the American Journal of Health-System Pharmacy reveals incongruities between the drug-gene interactions that appear in the U.S. Food and Drug Administration’s Table of Pharmacogenetic Associations and those that are referenced in widely consulted clinical guidelines published by the Clinical Pharmacogenetics Implementation Consortium (CPIC). The findings underline differing perspectives regarding the classification of certain gene-drug interactions that may deter clinicians from ordering pharmacogenetic (PGx) tests whose results would be difficult to interpret.

In comparing the drug-gene associations listed in FDA’s table with the guidelines published by CPIC, a team of authors including PMC Senior Vice President for Science Policy Daryl Pritchard, Ph.D., Atrium Health Cancer Pharmacology and Pharmacogenomics Chair Jai N. Patel, Pharm.D., PMC Program Manager Lindsay E. Stephens, and Intermountain Healthcare Executive Clinical Director of Precision Health Howard L. McLeod, Pharm.D., found that the same drug-gene associations and dosing implications were reported for only five of the 126 drugs that were listed by one or both sources. An additional 34 drugs were listed by both sources but with differing gene associations and dosing implications. The remaining 87 drugs were listed by only one of the two sources.

“This study reveals conflicting information regarding potential drug-gene interactions that undoubtedly cause confusion among health care providers, thereby slowing the integration of pharmacogenomics, one of the pillars of personalized medicine, into clinical care,” said PMC President Edward Abrahams.

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Contact:
Christopher J. Wells
cwells@personalizedmedicinecoalition.org
Phone: 202-580-9780

About the Personalized Medicine Coalition:
The Personalized Medicine Coalition, a 501(c)3 organization comprised of 14 distinct stakeholder groups within health care, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the health system.

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