23andMe Inc. Announces Relaunch of Direct-to-Consumer Genetic Testing Two Years After U.S. Food and Drug Administration ordered him to stop marketing health information from the test without agency approval.
The Mountain View, Calif., Company said it now has FDA clearance to sell a test it says can tell consumers if they are carriers of a genetic variant of any of the 36 rare diseases that could be transmitted to their offspring. The company will also provide data on certain “wellness” traits, such as a predisposition to lactose intolerance.
“We’re coming back,” said Anne Wojcicki, CEO of 23andMe. The revival follows the FDA decision in February to approve testing for a genetic variant for a rare condition known as Bloom syndrome. With FDA approval, the company included other conditions, such as cystic fibrosis and sickle cell anemia.
But the company is not yet authorized to provide information about a person’s risk of developing a serious disease such as Alzheimer’s disease or breast cancer, or to say whether it may have side effects in certain people. medications. The company previously provided this information to customers before the FDA ordered it to shut down.
“It won’t get them too far, but it may be a step on the way to getting them restarted where they were,” said Eric Topol, professor of genomics at the Scripps Research Institute, La Jolla, Calif. , who is not affiliated with the company.
The test, which previously cost $ 99, will be priced at $ 199.
More than a million people have purchased the test since its launch in 2007. Customers spit into a vial and their saliva is analyzed for some 650,000 different genetic variations.
In 2013, the FDA ordered the company to stop selling the test as a tool for assessing disease risk over concerns that false results could lead consumers to undergo unnecessary medical procedures. The agency was also uncertain whether consumers would understand the results without the help of a doctor or genetic counselor.
The agency also took the unusual step of publicly berating the company for failing to respond to its requests in a timely manner.
“We had a clear misinterpretation between what we thought we were doing was right and what the FDA wanted,” Ms. Wojcicki said in an interview. The company hired an expert in relations with regulators, which it said was a key step in improving relations with the agency.
The company continued to sell the test with information relating to the ancestry of customers.
Ms Wojcicki said the company has developed data demonstrating the ability of consumers to understand information. But she doesn’t have a timeline on when more data on disease risks and drug interactions could be restored in test results.
Robert Green, a medical geneticist at Harvard-affiliated Brigham and Women’s Hospital in Boston, called the revival “a good development for the field.” Dr Green, who has no financial connection to the company, said consumers should have the choice of obtaining genomic information through a doctor or directly through consumer testing.
“There is a legitimate concern on all sides as to whether people will understand or misunderstand complicated genetic information,” he said. But his research so far has shown that among the early adopters of such tests, “there is a very good understanding of what is being put forward.”
The FDA has not commented on the stimulus packages.
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Corrections and amplifications:
After the United States Food and Drug Administration ordered 23andMe Inc. in 2013 to stop marketing its genetic test to provide customers with medical information, the company continued to sell it to provide information about the ancestry of customers. An earlier version of this article incorrectly stated that the company also provides customers with information about certain physical traits. (October 21, 2015)
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