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23andMe's genetics screening service sold in violation of regulations, says FDA

2 December 2013
Appeared in BioNews 733

The US Food and Drug Administration (FDA) has ordered 23andMe to 'immediately discontinue' its Personal Genome Service (PGS) after failing to undergo proper agency approval for its marketing claims.

Alberto Gutierrez, director of the FDA's Center for Devices and Radiological Health, stated in a letter dated 22 November, that 23andMe had failed to address the agency's concerns that the tests could dangerously mislead people about their health.

23andMe first introduced the PGS to the market in 2007, and sells access to an array of information on more than 260 genetic conditions and traits, from a person's carrier status, disease risk, drug response and traits.

The warning letter, addressed to 23andMe co-founder Anne Wojcicki, targeted specific marketing claims about the PGS as a 'first step in prevention' that enables users to 'take steps toward mitigating serious diseases', including heart disease, and breast cancer.

Gutierrez wrote that the 'FDA is concerned about the public health consequences of inaccurate results from the PGS device'.

He mentions 'the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these'.

'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'.

Relying on the assessments for drug response could lead customers to 'self-manage' their treatment or abandon treatment altogether, resulting in illness, injury or death, according to the FDA.

The Federal Food, Drug and Cosmetics Act regulates products that are intended to diagnose, mitigate, treat or prevent disease.

The company must provide proof about how accurate its tests are as well as supplying information on the rate of false positives and false negatives.

'Most of these uses have not been classified and thus require premarket approval as FDA has explained to you on numerous occasions', said Gutierrez.

The FDA said it has had 'more than 14 face-to-face and teleconference meetings, hundreds of email exchanges, and dozens of written communications' with 23andMe to discuss compliance with the statute.

'The main purpose of compliance with FDA's regulatory requirements is to ensure that the tests work'.

'However, even after these many interactions with 23andMe, we still do not have any assurance that the firm has analytically or clinically validated the PGS for its intended uses, which have expanded from the uses that the firm identified in its submissions', Gutierrez wrote.

As such, the FDA writes that the applications are considered withdrawn and 23andMe must immediately discontinue marketing until it receives FDA authorisation for its claims.

Failure to take the proper action, the FDA warned, could lead to seizure, injunction, and civil money penalties.

23andMe co-founder Anne Wojcicki responded on the company's blog: 'In July 2012 23andMe submitted its first application for FDA clearance and followed on with another submission at the end of August'.

'We received feedback on those submissions and acknowledge that we are behind schedule with our responses'.

'This is new territory for both 23andMe and the FDA', she wrote.

23andMe, Inc. - Warning Letter
US Food and Drug Administration |  22 November 2013
23andMe Statement Regarding FDA Warning Letter
23andMe (press release) |  22 November 2013
An Update Regarding The FDA's Letter to 23andMe
23andMe Blog |  26 November 2013
An Update Regarding The FDA’s Letter to 23andMe
the 23andMe blog |  26 November 2013
FDA bans 23andme personal genetic tests
BBC News |  26 November 2013
FDA orders genetics company 23andMe to cease marketing of screening service
The Guardian |  25 November 2013
FDA warns 23andMe, tells genetic testing firm to halt sales
CBS News |  25 November 2013
FDA warns maker of genetic-testing kit
Washington Post |  26 November 2013
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