Gene testing company 23andMe 'not going anywhere'

DNA The $99 personal DNA test was designed to detect a range of gene variants

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Personal-genetics company 23andMe says it is "not going anywhere", after the Food and Drug Administration ordered it to stop marketing-spit testing kits.

"Our mission is unchanged," it says.

On Friday, the Californian company stopped giving its health-risk results - based on gene variants - to those who had bought the tests after 22 November.

The FDA feared they would make poor decisions, such as opting for unnecessary surgery on the basis of a risk for a gene linked to cancer.

Founded in 2006 by Linda Avey, Paul Cusenza and Anne Wojcicki, who reportedly separated recently from her husband, Google co-founder Sergey Brin, the company had offered results about a customer's risk for 254 diseases and conditions, including genes linked to diabetes, heart disease and breast cancer.

But last week, in response to the regulator's demands, the company, based in Mountain View and backed by wealthy investors, including Google, halted television, radio and online advertising for its $99 (£60) personal genome analysis product.

The health results had marked the company out from many other direct-to-consumer genetics companies, which are largely focused on providing information about ancestry alone.

The company's former rivals, Navigenics and deCODEme, have since disappeared from the market after being acquired by bigger companies.

But spokeswoman Catherine Afarian told US website Venturebeat: "We are not going anywhere, although we recognise that the FDA process will take time."

And she told BBC News the company "remains committed" to consumer genetics.

Warning letter

Many of the affected customers will reportedly be able to request a full refund, although they will continue to receive raw data and ancestry information.

Ms Afarian said the company was working hard to resolve the issues with the FDA and implied it might start to reintroduce aspects of its health tests in stages.

In its warning letter, the FDA said 23andMe had not provided assurances about how well the test predicted the presence or absence of a particular genetic variant or how well that genetic variant related to the risk of a specific disease.

The FDA said it was particularly concerned about the potential health consequences of assessments for drug sensitivity and a gene called BRCA linked to breast and ovarian cancer.

"For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognise an actual risk that may exist," the letter said.

Hank Greely, director of the Center for Law and the Biosciences at Stanford University, said the company would have to overhaul its methods for characterising genetic variants.

In a blog written at the time of the FDA order, he said: "The SNP chip method that 23andMe uses was never very good at providing useful genetic information.

"Its advantage has been its low cost. But as sequencing gets cheaper and cheaper, SNP chips have already largely become obsolete for most genetic testing."

Anne Wojcicki has said she stands by the data, and Ms Afarian said consumers had not been harmed.

Nevertheless, the company is being sued by customers in California, who say there is "no analytical or clinical validation for the [personal genomics service] for its advertised uses".

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