This week, the Association for Molecular Pathology issued a position statement on best practices for pharmacogenetic testing.
Some recommendations include the following (paraphrasing/emphasis mine):
- All health claims should have established clinical validity (i.e. CPIC guidelines or FDA labeling)
- Lab testing should have analytical validity and CLIA compliance
- Test reports should be comprehendible to non-PGx experts and include the following sections:
- List of drugs affected by the genotype/phenotype result
- General statement to consider therapy modification
- Resources for clinicians
Most notable may be the recommendation to include a list of drugs affected by genotype/phenotype as genetic testing companies are removing this section from their reports in light of recent FDA directives regarding gene-drug pair claims.
These recommendations make lots of pragmatic sense but in the current climate, it will be interesting to see their uptake. Also see GenomeWeb for additional commentary.
What are your thoughts, implementation community?