AMP bolsters position on consumer genomic testing

June 11, 2019

The Association for Molecular Pathology (AMP) revised its official position for all consumer genomic testing. Based on a recent assessment of the current market landscape and privacy best practices, the latest position statement features an expanded list of conditions that must be met before AMP can support a clinically meaningful test. AMP remains neutral to all recreational, novelty, and ancestry testing that may create educational opportunities for the public.

Over the past 12 years, AMP has been closely monitoring and evaluating the consumer genomic test market. In 2007, AMP issued a Direct to Consumer (DTC) Testing statement that concluded that healthcare-related genetic testing should be available only through appropriately qualified health professionals who order tests from CLIA certified laboratories. In 2015, that statement was revised to support clinically meaningful direct access genetic testing, as long as certain conditions are met. Since 2015, a working group of AMP leaders has continued to evaluate the current landscape of consumer genomic testing. The results of that evaluation revealed important updates and expansions to the conditions that must be met before AMP can support such testing. The new conditions 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.

The expanded set of conditions include:

• 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.

AMP continues to strongly oppose consumer genomic testing that provides information that is either not clinically valid or is used to sell secondary products or services, such as unsubstantiated claims concerning athleticism, diet, exercise, or cosmetics. The society recommends that policy mechanisms be created to ensure that marketing materials and reports clearly identify the lack of data to support health management and the secondary business interests associated with the test.

Read the full position statement on consumer genomic testing here