The Association for Molecular Pathology released a new position statement this week that expands the criteria a direct-to-consumer, clinically meaningful genomic testing product must meet in order to be backed by the AMP.
The organization, which represents pathologists, clinical laboratory directors and scientists across various disciplines of molecular diagnostics, first released guidelines regarding consumer genomic tests in 2007, followed by an update in 2015.
The latest update now requires producers of clinically meaningful genomic tests to provide, among other criteria, well-established clinical validity for all products' health-related claims; test validation and interpretation by board-certified molecular lab professionals; information about a test's validity in all marketing materials and results reports; explicit descriptions of a test's limitations; and referrals to genetic counselors and physicians when necessary.
The updated statement also maintains the AMP's neutrality regarding consumer genomic tests that provide non-clinical information about ancestry, lifestyle and genetics, and its strict opposition to those that make unsubstantiated claims in an attempt to sell diet, exercise, cosmetic and other products.
See the AMP's full statement on direct-to-consumer genomic testing here.
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