Direct-to-consumer (DTC) genetic testing happens outside the clinical setting. DTC tests are marketed directly to consumers who may then choose from companies that can look at different health conditions, traits, and ancestry. There are benefits but also risks related to DTC tests. Multiple professional societies have come with guidance regarding the adoption of these tests and their role in patient care.
Note: A DTC test might not provide a complete assessment risk, as some DTC companies may limit their analyses to specific mutations and/or do not take in to account an individual’s background risk
As a result of increasing data points, the need for interpretation of and counseling about any type of genetic testing regarding these disorders has become exponentially more complex, and in most instances, is not a part of general clinical genetics practice
In this context, the emergence of direct-to-consumer testing for multi/polygenic diseases is particularly troubling
…the ACMG is of the opinion that prenatal testing for disorders that exhibit multigenic or polygenic inheritance is not yet appropriate for clinical use and should not be offered as direct-to-consumer testing
The American College of Obstetricians and Gynecologists discourages direct-to-consumer genetic testing without appropriate counseling
Given the insufficient data to support the use of single nucleotide polymorphisms (SNP) testing for medical purposes, SNP testing to provide individual risk assessment for a variety of diseases or to tailor drug therapy outside of an institutional review board-approved research protocol is not recommended
The American College of Obstetricians and Gynecologists recommends that the use of these technologies be viewed as investigational at this time
Direct to consumer tests (FDA)
ACP Position Paper on Direct to Consumer Genetic Testing
ACMG: Direct-to-consumer genetic testing: a revised position statement of the American College of Medical Genetics and Genomics
ACOG Committee Opinion 816: Consumer Testing for Disease Risk
Direct-to-consumer prenatal testing for multigenic or polygenic disorders: a position statement of the American College of Medical Genetics and Genomics (ACMG)
AACC: Direct-to-Consumer Laboratory Testing
FDA authorizes, with special controls, direct-to-consumer test that reports three mutations in the BRCA breast cancer genes
MedlinePlus Genetics: Direct-to-Consumer Genetic Testing
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