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Confirmation practice in pharmacogenetic testing; how good is good enough?

Carin A T C Lunenburg1, Henk-Jan Guchelaar2, Ron H N van Schaik3

  • 1Department of Medical Oncology, Leiden University Medical Center, Leiden, the Netherlands.

Clinica Chimica Acta; International Journal of Clinical Chemistry
|December 25, 2018
PubMed
Summary

Confirmation practices in pharmacogenetic testing lack clear guidelines, leading to significant laboratory heterogeneity. A second independent genotyping technique is crucial for high-impact tests like DPYD to ensure accurate results.

Keywords:
ConfirmationGenotypingPharmacogeneticsQuality

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Area of Science:

  • Clinical Diagnostics
  • Pharmacogenetics
  • Molecular Biology

Background:

  • Pharmacogenetic testing is becoming standard in diagnostics.
  • Current quality control, specifically confirmation practices using dual genotyping techniques, lacks standardized guidelines and is debated.
  • This variability impacts the reliability of pharmacogenetic results.

Purpose of the Study:

  • To discuss current confirmation testing practices in pharmacogenetics.
  • To highlight the importance of accurate genotype assignment using DPYD genotyping as a case example.
  • To address the heterogeneity observed in laboratory confirmation methods.

Main Methods:

  • A survey was conducted to explore current laboratory confirmation practices in pharmacogenetics.
  • Analysis of over 10 years of genotyping results from two major genotyping facilities.
  • Both facilities employed a second, independent genotyping technique for confirmation.

Main Results:

  • Significant heterogeneity in confirmation practices was observed, with 54% of laboratories using varied methods.
  • Analysis of 10 years of data revealed discrepancies in only 9 patients (0.01%), potentially due to allele dropout.
  • Independent confirmation techniques proved effective in identifying rare discrepancies.

Conclusions:

  • A second, independent genotyping technique is valuable for pharmacogenetic tests with high clinical impact, such as DPYD testing.
  • Development of specific guidelines for confirmatory laboratory practices in pharmacogenetics is needed.
  • Guidelines should be gene- and test-specific to ensure consistent and accurate diagnostic outcomes.