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US Blocks Sale of a Company's Mail-Order Gene Tests

This image provided by 23andMe shows the company's logo. The U.S. Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits.
This image provided by 23andMe shows the company's logo. The U.S. Food and Drug Administration is ordering genetic test maker 23andMe to halt sales of its personalized DNA test kits.
U.S. health regulators have ordered a genetic-testing company to stop marketing its mail-order test kits, saying consumers might get false results that cause them to undergo unnecessary medical procedures.

A start-up company called 23andMe has been selling its $99 kits for five years. It had started a new marketing campaign before the government's Food and Drug Administration halted its sales until the firm proves that its tests are accurate.

The health regulators said they were concerned about "the public health consequences of inaccurate results."

The 23andMe name is a reference for DNA being organized into 23 pairs of chromosomes. It is one of several companies selling such test kits in the U.S. and has financial support from Internet search engine Google and a prominent U.S. pharmaceutical, Johnson & Johnson.

The company says it has traced the genes of more than 475,000 customers. It says the saliva-based test it uses can identify more than 240 genetic traits that could help people assess their health or risk of diseases.

But the government said a false positive from the tests could lead women to undergo unnecessary surgeries for breast or ovarian cancers, or a false negative could result in people failing to recognize actual risks.

The company acknowledged it had not met the regulators' timeline for submitting test results and said it would address concerns about its test kit.

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Comments
     
by: Steve from: Minneapolis
November 27, 2013 7:33 AM
The results give a percentage of risk. I ordered 23&ME a year ago and found it to be very interesting. I never even thought to use it as an absolute for diagnosis of a disease- just a percentage of possibility. Finding distant cousins has been very
enjoyable.

by: Erik from: Texas
November 26, 2013 12:06 PM
This is ridiculous. Oh no! What if a false positive happens?!? What if false negative!?!? What if?!? WHAT IF??!

These tests are just for informative purposes only! It only tells you that you have an increased or decreased risk. Nothing more. You take this info to your doctor and you let them figure it out.

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