NEW YORK – The Association for Molecular Pathology has issued a position statement on pharmacogenomic testing outlining best practices to which labs should adhere.
The pathologists' group recommends that labs report drug-gene associations that are backed by "well-established clinical validity" data from the peer-reviewed literature, practice guidelines, such as those from the Clinical Pharmacogenetics Implementation Consortium (CPIC), or US Food and Drug Administration-approved drug labeling.
Additionally, AMP urges labs to comply with federal lab standards outlined in the Clinical Laboratory Improvement Amendments and ensure that their tests are analytically valid, the quality of lab management systems are "robust," and the lab personnel are appropriately credentialed. "Tests must be verified under the supervision of, and interpreted and reported by, board-certified molecular laboratory professionals," AMP stated. "Additionally, as required by CLIA, details regarding analytical methodology, validity, and quality should be readily available to the healthcare providers upon request."
The association further specified how the test results should be communicated to healthcare providers to ensure those without genetics knowhow can comprehend the results. For example, the report should included a statement of a patient's metabolizer status as determined by the genotype detected via testing, a list of the drugs that may be impacted by this genotype, alternative dosing or treatments that doctors may consider, and a list of resources that could provide further information on these points.
AMP's position statement comes as the FDA has been pressuring labs to submit their pharmacogenomic tests for regulatory approval. For labs that chose to continue to offer testing through a CLIA-certified lab, but won't seek or haven't yet achieved FDA approval, the agency has been restricting the labs from reporting the drugs that patients may respond well or poorly to based on the genetic variants identified through testing. Not mentioning the drugs in a PGx test report would make it challenging for doctors to make sense of the genetic findings and render such tests clinically useless, industry players have pointed out.
The agency's recent actions have confused the lab industry, which has long been allowed to offer tests legally through CLIA-certified labs, and have agitated policy experts who believe the FDA lacks statutory authority to regulate lab-developed tests that have historically been overseen by the Centers for Medicare & Medicaid Services under CLIA. Regulatory experts are particularly troubled that in its communications about PGx testing, the FDA seems to be saying that only it can decide when a drug-gene association is scientifically valid and can be reported by labs for medical decision making. Some have even said this could be a First Amendment violation.Â
Among its recommendations, AMP doesn't mention that labs need to have FDA clearance or approval for their PGx tests. AMP historically has not supported FDA's attempts to extend its oversight to tests labs perform and market, arguing that any improvements to lab regulations should be done through changes to CLIA.
Although its present statement on PGx testing doesn't address this issue directly, the group's recommendations reflect its overarching position, by emphasizing the importance of CLIA certification for labs and by highlighting that Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines and peer-reviewed literature are sources of clinically valid PGx information, alongside FDA-approved labeling. "One organization that has established levels of evidence for pharmacogenomic tests based on literature review is the Clinical Pharmacogenetics Implementation Consortium," AMP stated, highlighting that it has endorsed CPIC's Term Standardization for Clinical Pharmacogenetics Test Results Project and encourages the use of CPIC's gene-drug practice guidelines.
One of the main reasons the FDA has given for stepping up regulations against labs offering PGx testing has been that patients might make treatment changes based on reports from unapproved tests without speaking to their doctors. AMP recognized this risk in its statement in light of more patients having direct access to genetic testing results through consumer genomics firms.Â
"Patients currently may have direct access to their laboratory test results," AMP stated. "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."