Pharmacogenetics in the clinical analysis laboratory: clinical practice, research, and drug development pipeline

Giuseppe Miscio, Giulia Paroni, Paola Bisceglia, Carolina Gravina, Maria Urbano, Madia Lozupone, Carla Piccininni, Michele Prisciandaro, Grazia Ciavarella, Antonio Daniele, Antonello Bellomo, Francesco Panza, Lazzaro Di Mauro, Antonio Greco, Davide Seripa

Research output: Contribution to journalArticlepeer-review


Introduction: Over the last decade, the spread of next-generation sequencing technology along with the rising cost in health management in national health systems has led to widespread use/abuse of pharmacogenetic tests (PGx) in the practice of many clinical disciplines. However, given their clinical significance, it is important to standardize these tests for having an interaction with the clinical analysis laboratory (CAL), in which a PGx service can meet these requirements. Areas covered: A diagnostic test must meet the criteria of reproducibility and validity for its utility in the clinical routine. This present review mainly describes the utility of introducing PGx tests in the CAL routine to produce correct results useful for setting up personalized drug treatments. Expert opinion: With a PGx service, CALs can provide the right tool to help clinicians to make better choices about different categories of drugs and their dosage and to manage the economic impact both in hospital-based settings and in National Health Services, throughout electronic health records. Advances in PGx also allow a new approach for pharmaceutical companies in order to improve drug development and clinical trials. As a result, CALs can achieve a powerful source of epidemiological, clinical, and research findings from PGx tests.

Original languageEnglish
Pages (from-to)751-765
Number of pages15
JournalExpert opinion on drug metabolism & toxicology
Issue number9
Publication statusPublished - Sep 1 2019


  • adverse drug reactions
  • Clinical laboratory analysis
  • pharmacogenetics
  • therapeutic failure

ASJC Scopus subject areas

  • Toxicology
  • Pharmacology


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