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# FDA Should Regulate Genetic Tests: Disability Council
- URL: https://www.fdaweb.com/fda-should-regulate-genetic-tests-disability-council/
- Published: 2019-10-23T12:00:00.000Z
- Updated: 2026-09-15T01:58:21.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5145322

The National Council on Disability (NCD), an independent federal agency, is [calling](https://www.marketwatch.com/press-release/federal-study-finds-unregulated-genetic-testing-industry-fails-to-provide-balanced-view-of-disability-calls-on-fda-ftc-for-oversight-2019-10-23?ref=fdaweb.com) on FDA to end its enforcement discretion and regulate laboratory diagnostic tests, and particularly noninvasive prenatal screenings, that it says have made prenatal genetic testing more commonly available to women of different ages, socioeconomic backgrounds, and health histories. The call for FDA action is included in “Genetic Testing and the Rush to Perfection,” the NCD report on the impacts of genetic testing, and particularly prenatal genetic testing, on people with disabilities and communities.

The report identifies areas of concern in the highly dynamic, profit-driven field of genetic testing as: 

- genetic counselors with inadequate training in disability cultural competence;
- potential conflicts of interest for genetic counselors employed by private commercial genetic testing entities;
- genetic counseling as a profession not recognized by the Centers for Medicare and Medicaid Services as a profession that can independently bill; and
- private entities that hold genetic information about fetuses and their parents, raising confidentiality and information-use concerns.

NCD also recommends that the Federal Trade Commission actively oversee the marketing claims and practices of prenatal genetic testing.