23andMe genome testing kit image

MHRA approves Google gene test for UK

pharmafile | December 2, 2014 | News story | Medical Communications, Research and Development, Sales and Marketing 23andME, DNA, FDA, MHRA, UK, US, gene, google, test 

The MHRA has approved a controversial genetic test for the UK – despite it being banned by the US FDA.

The UK drugs regulator has approved the £125 personal genome testing kits – which its manufacturers 23andMe claim offers individuals “more than 100 reports offering health, trait and ancestry information” – for sale in the UK from today.

The MHRA says 23andMe had met the minimum standards it uses for regulating personal genome services – but warned that people to check the CE mark of this and other personal genome tests, as ‘no test is 100% reliable’.

California-based 23andMe is backed by millions of dollars of investment from Google, whose co-founded Sergey Brin is married to the company’s chief executive Anne Wojcicki.

The company submitted applications to the FDA in July and September 2012. But in November the following year the FDA effectively banned the company from marketing its gene testing service in the US, because 23andMe had failed to provide evidence to back up its claims.

The FDA concluded that 23andMe could not market its test – which it deemed to be a medical device – without regulatory approval. In its letter the FDA said the company had subsequently failed to address the regulatory issues the FDA raised – including ‘particularly concerning’ questions around genetic testing for the breast cancer BRCA gene.

The FDA said 23andMe had “failed to provide adequate information to support a determination that the personalised genome service is substantially equivalent to a legally marketed predicate for any of the uses for which you are marketing it”.

Despite the objections by the US regulator, the UK MHRA has given the test the go-ahead. In the UK commercial testing products – but not the testing services themselves – are subject to medical devices legislation.

The MHRA has asked 23andMe to implement an enhanced vigilance system in order to further monitor the safety and performance of the product whilst on the UK market. 23andMe says its test results have an error margin of +/- 4 per cent.

Wojcicki adds that 23andMe is launching the test in the UK market as “the UK is a world leader in genomics”, which builds on the launch of Genomics England’s project to sequence the genomes of 100,000 people with cancer or rare diseases.

Mark Thomas, professor of evolutionary genetics at University College London, says: “For better or worse, direct-to-the-consumer genetic testing companies are here to stay. One could argue the rights and wrongs of such companies existing, but I suspect that ship has sailed.

“It is important that independent scientists and government bodies remain vigilant to ensure that such companies produce scientifically accurate, responsibly formatted and non-alarmist reports to their customers. The discussion should now focus on how such companies might interact with the medical profession for the benefit of their customers and society more generally.”

Lilian Anekwe

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