September 4, 2019 -- The Association for Molecular Pathology (AMP) has provided guidance on best practices for pharmacogenomic tests, including quality, compliance with CLIA, and reporting of results to health providers, in a position statement released on September 4.
The AMP endorsed the use of evidence-based guidelines for pharmacogenomic tests in clinical practice from the international Clinical Pharmacogenetics Implementation Consortium (CPIC). Pharmacogenomic information is already included in the prescribing information of hundreds of drugs approved by the U.S. Food and Drug Administration (FDA), the AMP noted.
"Pharmacogenomic tests that are offered clinically should demonstrate evidence of clinical validity before being offered to patients, the same standard as for other practices of medicine," the position statement advises. "Such evidence may be established and/or demonstrated through peer-reviewed literature, clinical practice guidelines, and/or FDA drug labels."
The top four takeaways for labs providing pharmacogenomic tests are as follows:
The release of the position statement comes amid growing use of precision medicine tests by the public and heightened regulatory scrutiny about potential dangers when they are used to guide drug treatments. Myriad Genetics is among the diagnostics companies that have drawn scrutiny from the U.S. Food and Drug Administration (FDA). During its earnings call last month, Myriad said it submitted a plan to the agency related to how test results are reported to health providers. Past actions on pharmacogenomic tests from the agency include a warning letter to Inova Genomics Laboratory in April.
During a special session on genetic testing at the American Association for Clinical Chemistry annual meeting in August, one expert noted that it can be difficult for healthcare providers -- let alone patients -- to interpret test results.
What to include
In its position statement, the AMP said that it "strongly supports" including the following in test reports:
The position statement is helpful for the continued use of companion diagnostic tests by pathologists, commented Bruce Carlson, publisher of Kalorama Information, a sister company of LabPulse.com.
"This important pathology group's recommendation to use clinical guidelines that have undergone serious review brings more authority to what can be, at times, an ad hoc practice of lining up drugs to testing products," Carlson said. "AMP's blessing of CPIC's specific instructions will help advance the cause of precision medicine."
Meanwhile, a series of evidence-based expert consensus opinion recommendations for genotyping assays is also being developed by an AMP working group.