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FDA grapples with regulation of DTC genetic tests
It has been another tumultuous few weeks for the world of consumer genetics. Following recent their announcement that the US Food and Drug Administration (FDA) would seek to regulate direct-to-consumer (DTC) genetic testing services as medical devices, communicated through a series of letters to the most prominent DTC genomics companies (see previous news), it has now sent a further 14 device notification letters out to a select but growing group of genetic test providers (see Genomics Law Report). The move occurred during the FDA’s widely publicised meeting on the regulation of laboratory-developed-tests (LDTs, see previous news), during which the matter of DTC tests was extensively discussed.
- INFORMATION: Appropriate information and a proportionate set of consent procedures should be in place prior to testing, such that the citizen is unambiguously informed about the nature of what he or she will receive by way of information and its possible implications
- ANALYTICAL VALIDITY: Laboratories providing an assay service should undergo accreditation procedures and subject themselves to stringent QA requirements (e.g. CLIA certification in the US), so that citizens themselves can have confidence in the genotypes that are generated
- SCIENTIFIC VALIDITY: Statutory regulations should be put in place to ensure that the scientific validity of the clinical claim is established, i.e. the link between the disorder and the genetic variant is established as a true and real relationship
- ACCESS TO ADVICE: All providers should ensure that consumers have access to named and appropriately qualified professionals with the necessary competence to interpret the assay measurement and provide advice and support to consumers regarding the interpretation of the test result to consumers
- CLAIMS: Guidelines and consumer protection regulations should either be strengthened to prevent misleading claims for the product or service, including unsubstantiated and overhyped assertions concerning clinical utility, or action should be taken to ensure that existing regulatory powers are enforced