Abstract
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The Association for Molecular Pathology (AMP) has expanded its set of conditions it wants met before it will support a clinically meaningful consumer genomic test. AMP said its expanded set of conditions are intended to reflect the range of currently available technologies, highlight privacy best practices, and encourage consumers to consult with their healthcare providers before making clinical care decisions.
All health-related claims must have well-established clinical validity.
The consumer genomic testing provider must comply with the CLIA statute and regulations. Test validation and interpretation should be performed by board-certified molecular laboratory professionals.
Information regarding the analytical and clinical validity of the tests should be present in all marketing materials and included in each report of results.
The consumer genomic test report should be in lay language and describe the limitations of the test, an interpretation of the finding(s) and significance for the consumer's health status, as well as implications for family members.
Test providers should adhere to The Future of Privacy Forum's “Privacy Best Practices for Consumer Genetic Testing Services.”
Consumer genomic testing providers should refer consumers to appropriate genetic counselors and recommend that they discuss any actionable test results with their physicians.
The additional conditions follow an evaluation of the current landscape of consumer genomic testing by a working group of AMP leaders first convened in 2015.
AMP said the working group's evaluation resulted in the association supporting new conditions designed to reflect the range of currently available technologies, highlight privacy best practices, and encourage consumers to consult with their healthcare providers before making clinical care decisions.
“We will continue to update our official consumer genomic testing position as needed to better account for all of the emerging technologies and privacy best practice,” Victoria M. Pratt, Ph.D., associate professor, director of pharmacogenetics and molecular genetics laboratories at Indiana University School of Medicine, and president of AMP, said in a statement. “As with any test relevant to a patient's health, we continue to strongly encourage consumers to consult with their healthcare providers before making clinical care decisions.”