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23andMe to relaunch consumer genetic tests in the US

22 October 2015

By Julianna Photopoulos

Appeared in BioNews 825

Genetic testing company 23andMe is relaunching its direct-to-consumer genetic tests in the USA, after receiving approval from the US Food and Drug Administration (FDA).

'We've worked with the FDA for nearly two years to establish a regulatory path for direct-to-consumer genetic testing,' said Anne Wojcicki, CEO of 23andMe, in a statement. 'We are a better company with a better product as a result of our work with the FDA.'

Based on a sample of saliva, the health-related service will now offer carrier data for 36 genetic diseases, such as sickle cell anaemia and cystic fibrosis, ancestry information, and predisposition tests to wellness and trait characteristics. It will not, however, indicate whether a person may have adverse reactions to certain drugs or test for common conditions – including breast and ovarian cancer, Alzheimer's and heart disease – like the company's previous offering.

The New York Times reported that it is unclear whether the carrier information alone will be compelling; carrier mutations are known to cause health issues when children receive mutated genes from both parents and there are separate carrier tests available through doctors from other laboratories. Ms Wojcicki says that she still hopes 23andMe will gain FDA approval to provide information on health risks.

The company previously covered 254 inherited diseases and provided users with information about their risk of developing these conditions, before this service was discontinued in 2013 on the orders of the FDA (see BioNews 733). The FDA said that the company's services failed to provide evidence on the reliability of its results.

'It is worth noting that the new product is very different than 23andMe's previous Personal Genome Service, which attempted to provide consumers with personalised risk estimates for conditions that have genetic components,' said Dr Brian Zikmund-Fisher from the University of Michigan.

He added: 'Part of the problem with that effort was that the 23andMe report could not possibly reflect the behavioural and environmental factors that influence many diseases like diabetes.

'Such risk estimates are also difficult for people to interpret without medical help.'

Professor Robert Green, a medical geneticist from Harvard-affiliated Brigham and Women's Hospital, told The Wall Street Journal: 'There is legitimate concern from all quarters about whether people will understand or misunderstand complicated genetic information.' Even so, his research so far has shown that among early adopters of such tests, 'there is very good comprehension of what is being put forward'.

23andMe says it has redesigned its website to make personalised genetic information easier to understand and has raised the price of its service from $99 to $199 (£130).

The company also operates in the UK (see BioNews 783), offering reports on more than 100 inherited health conditions and traits.

RELATED ARTICLES FROM THE BIONEWS ARCHIVE

13 November 2017 - by Jamie Rickman 
The US Food and Drugs Administration has further deregulated direct-to-consumer genetic health risk tests, meaning that some will be approved for market without a pre-market review...
31 October 2016 - by Kulraj Singh Bhangra 
Personal genomics company 23andMe has halted plans to develop next-generation sequencing technology, it has revealed ...
21 March 2016 - by Ryan Ross 
A recent study has suggested that genetic tests to assess the risk of diseases like diabetes and lung cancer do little to motivate people to change their behaviour...
15 February 2016 - by Kulraj Singh Bhangra 
US start-up company Sure Genomics has launched the first whole-genome testing service available directly to consumers, for a cost of $2500...
15 February 2016 - by Dr James Heather 
The prolific and popular 'Stuff You Should Know' podcast takes us down the pub to talk personalised medicine...

05 May 2015 - by BioNews 
For the 800th issue of BioNews, we asked Anne Wojcicki eight questions about personal genomics company 23andMe...

16 March 2015 - by Arit Udoh 
US-based genetic testing company, 23andMe, has announced plans to use its customers' data for research and drug development...
23 February 2015 - by Alice Hazelton 
Genetic testing company 23andMe has obtained approval from the US Food and Drug Administration to market a direct-to-consumer genetic test for a rare mutation....
08 December 2014 - by Arit Udoh 
US-based genetic testing company 23andMe has launched its controversial 'personal genome service' in the UK...
09 December 2013 - by Ruth Saunders 
Genetic testing company 23andMe, which last week suspended the sale of its health-related genetic tests, is now facing a class action lawsuit in California over its marketing claims....

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