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Pathology Group Sets Expectations for DTC Genetic Tests

The Association for Molecular Pathology released an updated position statement with an expanded set of standards the group said should be met by providers of genetic tests marketed directly to consumers.

Health-related claims must have well-established clinical validity, test providers must comply with CMS' Clinical Laboratory Improvement Amendments (CLIA) regulations, and board-certified molecular laboratory professionals should perform all test validation and interpretation, AMP said.

Further, all marketing materials and result reports should include information on a test's analytical and clinical validity, the group said. Test reports should be in clear language that describes the limitations of the test, the significance of the findings for the consumer's health and the implications for family members.


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