US disability council urges greater regulation of genetic testing

The US National Council on Disability (NCD) has published a new report calling for greater oversight of genetic testing, particularly prenatal testing.

The report by the independent federal agency examines the impacts of these tests on people with disabilities and disability communities. The NCD's recommendations are 'aimed at greater federal and state oversight and quality control of genetic tests, and improving genetic counsellor education on disability' wrote NCD Chairman Neil Romano in a letter to the US President.

'Genetic testing offers the world an abundance of information, but that information isn't often contextualised with lived experience,' said Jim Brett, an NCD council member. 'Ensuring the entire process of genetic testing - recommending it and interpreting it - doesn't perpetuate misinformation about disability is key.'

The NCD highlighted concerns that adult and prenatal genetic testing had rapidly expanded in the USA with little regulation or oversight – and in particular, NIPT (non-invasive prenatal testing) which analyses fetal DNA to indicate the chances of a fetus having a genetic condition.

The report called for an end to the FDA's enforcement discretion on laboratory-developed tests, and for the regulation of NIPT to establish and enforce standards for the accuracy of claims made. Alongside this, the NCD recommended more oversight of marketing claims and practices by prenatal genetic testing entities.

The NCD also emphasised concerns over a lack of in-depth genetic counselling accompanying the tests and what the outcomes mean. The report noted 'inadequate training in disability cultural competence' for genetic counsellors.

The agency also highlighted potential conflicts of interest, as many genetic counsellors are provided by the genetic testing company rather than the clinic. 

'These tests and the way they're talked about weigh heavily on decisions families make,' said Mr Brett. 'We have a responsibility to ensure people have as much quality information as possible and a full and accurate understanding of it.'

The report also discussed concerns on the use and security of confidential genetic information held by private entities.

'The existing "hands off" status quo is not an option in the highly dynamic, profit-driven field of genetic testing', the report stated.

The document, entitled 'Genetic Testing and the Rush to Perfection' is part of the NCD's bioethics and disability series on how devaluation of the lives of people with disabilities perpetuates unequal access to medical care.