22 October 2015
ByAppeared in BioNews 825
'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.