‘Snake oil’ genetic tests marketed to produce ‘designer babies’ do not work, experts claimed today.
Some fertility clinics in the US have started offering polygenic risk score tests which claim to predict genetic conditions such as heart disease and type 1 diabetes in embryos. And there are fears the technology could go on to be used to help pick out desirable traits, such as height and intelligence.
The tests cost around £1,000 for a single test and upwards of £3,000 for a full round of IVF.
But a consortium of European experts has slammed the practice for a lack of clinical proof, calling for them to be banned until further research is done.
Embryo biopsies needed to perform the tests can accidentally damage the fertilised eggs because the process delays cell division by a few hours. This may force couples into another round of costly IVF, the panel warned.
Polygenic risk testing differs from preimplantation genetic diagnosis (PGD), which is legal in the UK. PGD is used to screen for 500 diseases including cystic fibrosis that have a single gene mutation that triggers them.
But most illnesses associated with DNA quirks — like heart disease or type 1 diabetes — are caused by multiple genes, which can also affect other areas of the body in different ways.
Professor Markus Perola, a geneticist at the University of Helsinki, described the tests as ‘unusable, unethical and unpractical’.
Aurea Smigrodzki was the first person to be born after undergoing polygenic tests in May 2020 after her parents chose a specific embryo.
‘Snake oil’ genetic tests marketed to produce designer babies do not work and can cause harm to embryos, experts claimed today. Pictured: A preconception screening kit — which can give couples thinking of having a baby some idea of what their offspring’s predisposition to certain conditions and diseases might be — Orchid Biosciences, who also provide polygenic risk score tests
Professor Markus Perola (left), a geneticist at the University of Helsinki, described the tests as ‘unusable, unethical and unpractical’. Dr Francesca Forzano (right), a medic at King’s College London, warned prospective IVF parents in Britain not to be lured across the Atlantic for the tests
More than 390,000 babies have been born with IVF in Britain since the treatment was first made available in 1991. US?
Polygenic risk scores are not currently available on the NHS, but their legal status in private clinics remains murky.
The tests are currently offered by US companies, including Genomic Production in New Jersey and Orchid Biosciences in California.
It is not offered on the NHS in Britain but is not technically illegal in private practices, with the Human Fertilisation and Embryology Authority regulator not able to prevent the treatments being given.
Experts warned British couples seeking IVF treatment not to be lured across the Atlantic for the costly treatments.
The warning was published in the European Journal of Human Genetics.
HOW DOES IVF WORK?
In-vitro fertilisation, known as IVF, is a medical procedure in which a woman has a fertilised egg inserted into her womb to become pregnant.
It is used when couples are unable to conceive naturally, and a sperm and egg are removed from their bodies and combined in a laboratory before the embryo is inserted into the woman.
Once the embryo is in the womb, the pregnancy should continue as normal.
The procedure can be done using eggs and sperm from a couple or those from donors.
Guidelines from the National Institute for Health and Care Excellence (NICE) recommends that IVF should be offered on the NHS to women under 43 who have been trying to conceive through regular unprotected sex for two years.
People can also pay for IVF privately, which costs an average of £3,348 for a single cycle, according to figures published in January 2018, and there is no guarantee of success.
The NHS says success rates for women under 35 are about 29 per cent, with the chance of a successful cycle reducing as they age.
Around eight million babies are thought to have been born due to IVF since the first ever case, British woman Louise Brown, was born in 1978.
Chances of success
The success rate of IVF depends on the age of the woman undergoing treatment, as well as the cause of the infertility (if it’s known).
Younger women are more likely to have a successful pregnancy.
IVF isn’t usually recommended for women over the age of 42 because the chances of a successful pregnancy are thought to be too low.
Between 2014 and 2016 the percentage of IVF treatments that resulted in a live birth was:
29 per cent for women under 35
23 per cent for women aged 35 to 37
15 per cent for women aged 38 to 39
9 per cent for women aged 40 to 42
3 per cent for women aged 43 to 44
2 per cent for women aged over 44
Asked if prospective parents should be aware of being duped, Dr Francesca Forzano, a medic at King’s College London, told a press conference: ‘This is the message.
‘We do not really have any say on what individuals can do.
‘There are a lot of situations when couples have moved from one country to another within Europe to have IVF practices not allowed in their country.
‘This is a private market, so it is very different to what is an NHS embedded activity so it is very difficult to have a clear sense what is happening in the population.’
They also claimed the murky science behind the tests is particularly ineffective for couples from non-white backgrounds, because the studies behind the tests usually used data from European groups.
They argued there is currently no clinical research to support the tests’ use in selecting desirable traits in embryos during IVF.
Researchers currently use polygenic risk scores to study genetic diseases, but no clinical research has been done on how safe or effective it is in an IVF setting.
Professor Maurizio Genuardi, president of the European Society of Human Genetics, said: ‘At the current stage [polygenic test scores] cannot be used [in IVF screening].
‘The main problem is there are institutions that sell these tests to parents with the hope that this can be helpful to select better embryos — designer babies.
‘But the information that is provided is not accurate.
‘If we consider couples as patients, it is not correct to offer these tests because they have no benefit. We are making them pay for something that has no benefit.
‘If they are considered customers, the hope they will have better babies is misleading at best because there is no evidence.’
Despite the lack of research, private clinics have been offering the tests to prospective parents in the US for the past few years.
Experts said the tests can be risky because it is not always clear how genes that cause certain disease risks might be benefitting people in other ways.
They say deliberately selecting to remove them could have bad consequences as a result.
Also, the chances of being able to select for specific favourable characteristics — such as musical ability or beauty — are almost impossible, Professor Perola said.
In a theoretical example, he explained if the chances of being of high intelligence, height and another desirable trait are all five per cent, the probability of a successful embryo having all three would be just one in 16,000.
This means the IVF procedure would ‘easily’ need tens of thousands of embryos to be effective at selecting.
Typically, between eight and 14 eggs are retrieved in a round of IVF.
The proportion of all IVF cycles to patients aged 40-plus has more than doubled from 10 per cent (689 cycles) in 1991 to 21 per cent (14,761 cycles) in 2019, according to the Human Fertilisation and Embryology Authority (HFEA) (stock image)
Speaking at a press briefing today, he said: ‘If you sell this kind of thing, I would say you are selling snake oil.
‘I’m not here to tell you polygenic risk scores do not work in research.
‘I’m here to tell you why they are practically impossible to use in genetic selection.
‘Polygenic tests for selection are currently unusable, unethical and unpractical and pretty much any other “un” word you can think of.’
Dr Forzano also called for the HFEA to be given the power to investigate and stop the practice in private clinics in Britain.
Her calls were echoed by infertility charities, who slammed ‘neither scientifically nor ethically legitimate’ companies for providing the tests.
Sarah Norcross, director of Progress Educational Trust, said the charity supports the warning to parnets not to ‘waste their money’ on the tests.
She called on the HFEA to clarify the ‘legal and regulatory status of such tests within the UK’
Ms Norcross said: ‘The Advertising Standards Authority and the Competition and Markets Authority should keep a careful eye on whether and how such tests are marketed to UK patients.
‘It is neither scientifically nor ethically legitimate to try to select embryos using polygenic risk scores.’
She continued: ‘ Even if — for the sake of argument, and despite a complete lack of clinical evidence — a polygenic risk score could meaningfully predict certain things about certain embryos, the sheer number of embryos that would be needed to make use of this test could not be achieved in a clinical setting.
‘There are precious few embryos to choose from in a fertility treatment context, and so reasons for preferring one embryo over another must be grounded in clear evidence.
‘Preimplantation genetic testing for monogenic conditions is evidence based, whereas preimplantation genetic testing using polygenic risk scores is not.’