The Association for Molecular Pathology (AMP) today published a position statement for pharmacogenomic testing that spells out “best practices” criteria for laboratories to follow.
The three-page statement included criteria that are designed to ensure responsible use of the tests, while preserving broad access and improving patient care, according to AMP. Among the Association’s recommendations is that all health-related pharmacogenomic claims must have well-established clinical validity.
“The drug-gene association must be robust and supported by strong scientific evidence in the peer-reviewed literature, in the FDA-approved drug label, and/or in clinical practice guidelines, such as those created by CPIC [The Clinical Pharmacogenetics Implementation Consortium],” according to the statement.
AMP also stated that pharmacogenomic testing providers must comply with the Clinical Laboratory Improvement Amendments of 1988 (CLIA) statute and regulations, as is required for all other clinical laboratory tests. That compliance, the Association said, must include documented analytical validity, a robust quality management system, and appropriately licensed or credentialed laboratory personnel.
In addition, AMP stated, the pharmacogenomic test report should be comprehendible by healthcare providers and include the interpretation of the findings, the significance of the results, as well as the limitations of the test.
AMP said it strongly including in tests reports that include interpretation of the findings and the significance of pharmacogenomic test results:
- A statement of the metabolizer status determined by the genotype for the genes that affect drug metabolism.
- A list of the drugs for which responsiveness may be affected by the genotype.
- A generalized statement to alert healthcare providers when alternate dosage or drug treatment may be considered based on the results.
- A list of resources and references designed to help healthcare providers learn more about the genotyping result, the drug-gene association, and how to incorporate the result into actionable decisions.
“These resources can include pointing healthcare providers to CPIC guidelines and/or peer-reviewed literature,” according to AMP.
AMP added that it strongly recommends that patients not change their treatment plan without first talking to their healthcare provider: “Clinically meaningful pharmacogenomic tests are poised to improve patient care and professional practice, provided certain conditions are met.”
AMP’s best-practices statement comes nearly a year after the FDA on October 31, 2018, issued a “Safety Communication” warning patients and healthcare providers not to change patient medication regimens based on results from genetic tests claiming to predict a patient’s response to specific medications, but which are not supported by scientific or clinical evidence.
In April, Inova Genomics Laboratory ended MediMap testing after it was accused by the agency of “illegally” marketing genetic tests that had not been reviewed by the agency for safety and effectiveness. Initially, Inova noted that it had been offering MediMap tests under what it termed “FDA’s policy of enforcement discretion for laboratory developed tests (LDTs), as previously described in the FDA’s publicly available statements and documents.”
“It appears that you have addressed the violation(s),” the FDA told Inova in a May 24 letter written by Timothy T. Stenzel, M.D., Ph.D., Director of the agency’s Office of In Vitro Diagnostics and Radiological Health.
Appearing to acknowledge the FDA’s concern about patients acting solely based on test results, the AMP statement included: “Any result of a pharmacogenomic test should be discussed with the patient’s healthcare provider to determine whether changes to the patient’s medication plan are recommended.”
