Monday, February 23, 2015

AMP's language on clinically relevant DTC genetic tests.

In early 2015, the AMP updated its recommendations for DTC genetic testing.   It supported "access to clinically meaningful genetic testing" on a "direct access" (no prescription) basis, with several conditions.  For the full document see here.   What the AMP wrote is not far off from what the FDA required of 23andMe (here).

AMP Supports:

 Direct access to clinically meaningful genetic testing may add value to patients and consumers, when certain standards are met. Accordingly, AMP now supports direct access genetic testing for clinically meaningful tests under the following conditions:

  • The association between the genetic marker for which testing is performed and the relevant disease must be robust and supported by strong scientific evidence in the peer reviewed literature, and/or be based on evidence referenced or annotated in current genetic/genomic databases. 
  • Testing should comply with the CLIA statute and regulations, and all applicable state and federal laws and regulations. 
  • Transparency regarding the analytical and clinical validity of the tests should be present in all marketing materials and included in the report. Specifications include but are not limited to, analytical and clinical sensitivity/ specificity, and the limitations of assay. These should be described in terms understandable to an educated lay reader (see next bullet point). In addition, the underlying data and analytical methodology, including computational and/or statistical methods employed, power analyses, confidence analyses, etc. upon request should be readily available to health professionals. 
  • Reporting of test results and the limitations of the test should be in lay language. Additionally, the report should include an interpretation of the finding and describe its significance for the consumer’s health status. 
  • Test validation and interpretation should be performed by certified molecular laboratory professionals. 
  • AMP strongly supports referral for genetic counseling services and the provision of educational materials. Test providers should encourage genetic counseling as an additional step for consumer education. Resources such as referrals to the National Society of Genetic Counselors’ directory or through genetic counseling contracting services are considered appropriate. 
  • Direct access laboratories should recommend that consumers discuss their test results with their physicians. 
For my blog on a half-dozen recent AMP positions (as of early 2015) see here.

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