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National Council on Disability Recommends More Regulation of NIPT

NEW YORK – The National Council on Disability has issued a new report, calling for more regulation of genetic testing, especially noninvasive prenatal testing.

The nonpartisan, US government agency made specific recommendations for Congress and federal authorities, including the Food and Drug Administration, the Federal Trade Commission, and the Centers for Medicare and Medicaid Services (CMS.) The recommendations are "aimed at greater federal and state oversight and quality control of genetic tests, and improving genetic counselor education on disability," NCD Chairman Neil Romano wrote a letter presenting the report to President Donald Trump.

Among the council's specific recommendations were that Congress write new "sunshine and conflict of interest" laws disclosing financial relationships between genetic counselors, healthcare providers, and commercial laboratories; that FDA "end enforcement discretion and regulate laboratory-developed tests, specifically, noninvasive prenatal screening, to establish and enforce standards for the accuracy of any claims made by prenatal genetic testing entities"; and that the FTC conduct more oversight of the marketing claims and business practices of genetic testing companies.

"The existing 'hands off' status quo is not an option in the highly dynamic, profit-driven field of genetic testing. The rapid pace of genetic technology, and the willingness of 'rogue' scientists to experiment with human subjects force scientists, academics, and members of the public to confront a foundational question: Do we control genetic technology, or does it control us?" the report said.

The report, titled "Genetic Testing and the Rush to Perfection," is the third of a five-part series on bioethics and disability the NCD is releasing between Sept. 25 and Nov. 20. Other reports are entitled "Organ Transplant Discrimination Against People with Disabilities," "The Danger of Assisted Suicide Laws," "Quality-Adjusted Life Years and the Devaluation of Life with a Disability," and "Medical Futility and Disability Bias." Parts of the report echo earlier concerns about genetic testing, including past FDA proposals to evaluate LDTs for both analytical and clinical validity.

NCD also detailed concerns about the genetic testing market, including "inadequate training in disability cultural competence" for genetic counsellors, the lack of recognition for genetic counselors by CMS and their inability to be reimbursed by Medicare and Medicaid, and the use and security of confidential genetic information held by private entities.

The report stated that the recommendations are intended to ensure that "providers and patients get accurate, balanced information about the medical and social functional needs that come when a child has a specific genetically inherited condition."

"Genetic testing offers the world an abundance of information, but that information isn't often contextualized with lived experience," NCD Council Member Jim Brett said in a statement. "Ensuring the entire process of genetic testing — recommending it and interpreting it — doesn't perpetuate misinformation about disability is key."