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US disability council urges greater regulation of genetic testing

4 November 2019
Appeared in BioNews 1022

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.

Federal study finds unregulated genetic testing industry fails to provide balanced view of disability; calls on FDA, FTC for oversight
US National Council on Disability |  23 October 2019
Genetic Testing and the Rush to Perfection (pdf)
US National Council on Disability |  23 October 2019
National Council on Disability recommends more regulation of genetic testing
Modern Healthcare |  29 October 2019
National Council on Disability Recommends More Regulation of NIPT
360Dx |  23 October 2019
NCD Letter to FDA on Genetic Testing
US National Council on Disability |  28 October 2019
24 May 2021 - by Dr Hazar Haidar, Professor Vardit Ravitsky and Dr Anne-Marie Laberge 
Non-invasive prenatal testing (NIPT) was first introduced in 2011, when breakthroughs in sequencing technology allowed the analysis of cell-free fetal DNA (cffDNA) in maternal blood to detect genetic abnormalities in the foetus, such as trisomy 21 (Down's syndrome), with greater accuracy than previous screening tests...
17 August 2020 - by Dr Valerie Shaikly 
'People think if we do a genetic test, we can look for everything and if it comes back as a normal test, then everything will be healthy', says Jill Fischer...
6 January 2020 - by Dr Helen Robertson 
The Pentagon is advising members of the US military not to use commercial DNA testing kits, stating that they could pose a security concern...
25 November 2019 - by Louisa Ghevaert 
We are currently experiencing powerful digital, artificial intelligence, genomic science, epigenetic and human reproductive revolutions. These will increasingly blur the lines between the physical, digital and biological spheres...
24 September 2018 - by Rikita Patel 
Prenatal tests offered by private UK clinics are misused for sex-selection and could lead to abortions of female fetuses, according to a BBC investigation...
6 March 2017 - by Nick Meade 
The Nuffield Council of Bioethics' new report on non-invasive prenatal testing is unnecessarily negative and encroaches on women's reproductive choices...
6 March 2017 - by Emma Laycock 
The Nuffield Council on Bioethics has called for a ban on using early prenatal testing to find out the sex or sequence the whole genome of the fetus...
3 October 2016 - by Victoria Woodham 
The introduction of non-invasive prenatal testing in the NHS screening programme for pregnant women may seem like a no-brainer, but it is based on outdated ideas of what life is like for people with Down's syndrome and their families...
15 August 2016 - by Jane Fisher and Professor Lyn Chitty 
A central tenet of prenatal testing is to promote reproductive autonomy by providing women with information that can assist in pregnancy management. Bringing NIPT into the NHS will improve an established screening programme...
Comment ( - 05/11/2019)
People suffering from inherited diseases (e.g. recessive) who formerly were not able to reach sexual maturity and give birth to children, represented a stop for spreading the genetic defect. Nowadays in case they can be cured they  can transfer the defective gene to  all of their children, which increases the risk of giving birth children suffering from the same disease.
The risk depends on population prevalence of disease causing  mutation.
For this reason genetic testing  of healthy partner could help wihout any doubt.
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