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Opening the door to genetic testing and its potential health benefits to anyone with $99 and the desire to spit into a test tube is an exciting prospect. But only if the tests are accurate, the interpretations meaningful, and the results understandable to the average consumer.
That's what the Food and Drug Administration was trying to ensure when it recently warned DNA-testing service 23andMe to stop marketing and selling its health-related DNA tests directly to consumers until it gets government clearance. The FDA's scathing letter said the company had failed to provide studies the agency has been seeking for years.
The Mountain View, Calif., company, which had until Monday to comply, halted sales Dec. 5 and says it has been cooperating with the FDA. Good.
For the last six years, 23andMe has tested the DNA of a half-million customers who bought a kit on the Internet and sent back a saliva sample. After analysis, customers log on to the company's website to find out whether they might be prone to a long list of diseases, from diabetes to Alzheimer's, be...
That's what the Food and Drug Administration was trying to ensure when it recently warned DNA-testing service 23andMe to stop marketing and selling its health-related DNA tests directly to consumers until it gets government clearance. The FDA's scathing letter said the company had failed to provide studies the agency has been seeking for years.
The Mountain View, Calif., company, which had until Monday to comply, halted sales Dec. 5 and says it has been cooperating with the FDA. Good.
For the last six years, 23andMe has tested the DNA of a half-million customers who bought a kit on the Internet and sent back a saliva sample. After analysis, customers log on to the company's website to find out whether they might be prone to a long list of diseases, from diabetes to Alzheimer's, be...