Two years ago, the genetic testing company 23andMe introduced health screening tools, but was forced to withdraw them by the Food and Drug Administration because it could not show they were accurate. Now, the Silicon Valley company is reintroducing these screening tools with the FDA's approval, which it received earlier this year.
23andMe said it will offer 35 tests that tell users whether they carry genetic mutations for inherited diseases such as cystic fibrosis. The company had been criticized for its direct approach to consumers about genetic testing.
The relaunch comes as the Silicon Valley company works to mend its relationship with the Food and Drug Administration and with medical experts who have criticized the company's direct-to-consumer approach. FDA officials ordered the company to stop selling the tests to consumer because the tests required federal review and because there were fears that consumers would misinterpret test results.
23andMe submitted studies to the FDA showing that users were able understand genetic test results without the aid of a doctor or genetic counselor, said the company's CEO, Anne Wojcicki.
The relaunch is not a complete victory for the company. 23andMe is still not allowed to offer more than 250 risk reports that were included in its original product line. These reports were supposed to tell users if they were likely to develop diseases such as Alzheimer's and Parkinson's. Those reports and others related to drug reactions are not available in the United States. The company also information about family history and ancestry in addition to genetic information, based on a sample of saliva.
23andMe said earlier this year that it would resume selling certain health tests later this year.
More than 1 million people have used the company's test kit, which is a plastic tube that customers fill with spit and return to the company for processing. About 80% of those customers have authorized the company to sell their data to the pharmaceutical industry and researchers for research purposes.
The company will charge $199 per person, an increase from the earlier fee of $99.
