Objective:

To aid clinical lab professionals in designing and validating clinical CYP2C19 genotyping assays and to promote standardization of testing across laboratories, according to the Association for Molecular Pathology.

Approach:

• Recommendations Overview: The guidelines from the Association for Molecular Pathology outline a two-tier system for CYP2C19 assays, with Tier 1 recommending a minimum set of alleles and Tier 2 providing optional additional alleles.

Key Findings:

• Most laboratories are already testing for CYP2C19*2, CYP2C19*3, and CYP2C19*17.
• The recommendations are based on evidence published at the time and aim to improve professional pharmacogenetics practice.

Interpretation:

The recommendations are intended to enhance the validity of CYP2C19 assays.

Limitations:

• The recommendations are not legally binding.
• The field of pharmacogenetics is rapidly evolving, which may necessitate future updates to the guidelines as stated by the Association for Molecular Pathology.

Conclusion:

The AMP PGx Working Group will continually assess new evidence and technologies to update the recommendations as necessary.

Sources:

• Association for Molecular Pathology