NEW YORK (GenomeWeb) — The Association for Molecular Pathology (AMP) today updated its official position on direct-to-consumer genomic testing for healthcare decision making, offering an expanded list of conditions that tests must meet before gaining the organization's support.
While AMP had previously concluded that genomic tests should only be available to consumers through health professionals who order them through CLIA-certified labs, in 2015 the Rockville, Maryland-based group changed its position to support direct consumer access under certain conditions. Following continued evaluation of the consumer genomic testing field, AMP has now updated this list of conditions to reflect currently available technologies, privacy best practices, and the benefits of consumers consulting healthcare providers when making clinical care decisions.
According to AMP, this updated list includes the requirement that health-related claims have well-established clinical validity, with robust gene-disease associations that are supported by strong scientific evidence.
Additionally, DTC genomic test providers must comply with the CLIA statute and regulations, with test validation and interpretation performed by board-certified molecular laboratory professionals; information on the analytical and clinical validity of the tests should be present in all marketing materials and included in each consumer's report of laboratory results; and any test reports should be provided in lay language, note the limitations of the test, and include an interpretation of test findings and their significance for the consumer and their family.
According to AMP, test providers should also adhere to Privacy Best Practices for Consumer Genetic Testing Services, which was released by the Washington, DC-based non-profit Future of Privacy Forum last year, and recommend that consumers discuss any actionable results with their physicians.
"[T]his revised position statement is based on our collective knowledge and expertise of this rapidly developing field," AMP President Victoria Pratt said in a statement. "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 practices. 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."
In its position statement, AMP said it remains neutral on recreational, novelty, lifestyle, and ancestry genetic testing, while it opposed DTC genomic tests that are not clinically valid and/or that are used to sell additional products and services.
The full position statement can be found here.