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Gene testing

Genetic testing company mixes up results, customers confused about their origins

Tuesday, October 05, 2010 by: David Gutierrez, staff writer
Tags: gene testing, origins, health news

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(NaturalNews) Personal genetic testing company 23andMe has admitted that it mixed up the results of nearly 100 customers' tests, delivering incorrect information to them about ancestry and supposed disease risk.

The company, which is funded by Google and Genentech, has customers send in a saliva swab and then charges them $500 to scan their DNA for the risk of certain hereditary diseases. It is one of several personal genetic screening companies that have sprung up in the decade since the completion of the Human Genome Project.

In June, however, the company mixed up the results of 96 different tests, delivering incorrect information leading one woman to believe that her son was not related to her and another to believe that her ancestry was 69 percent African even though everyone else in her family was 100 percent ethnically European.

The mix-up led the FDA to speed up its push for regulation of personal genetic testing. The agency sent letters to five companies -- 23andMe, Navigenics, deCODE Genetics, Illumina and Knome -- ordering them to submit their tests for agency testing and approval.

The FDA's regulatory push began in May, following controversy over a short-lived plan to sell similar tests over the counter at Walgreens pharmacy.

Critics of personal genetic screening object that because genomics is still such a poorly understood science -- the genetic contribution to disease remains largely unknown and the interactions between genes and environmental factors is even less understood -- such tests may lead patients to make dangerous medical decisions based on faulty information.

"Your website states that the [product] provides personalized information on which medications are more likely to work best for you given your genetic makeup," the agency wrote in its letter to Navigenics. "It also states that the data generated from the Navigenics Health Compass provide patients with genetic predispositions for important health conditions. ... Consumers may make medical decisions in reliance on this information."

Sources for this story include: http://www.ft.com/cms/s/0/ed476afc-7715-11df... http://www.chicagotribune.com/business/ct-bi... http://articles.sfgate.com/2010-06-11/news/2... http://seattletimes.nwsource.com/html/health....

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