23andMe Relaunches After FDA Shut Down Over Questionable Science
After the FDA ordered a shutdown in 2013, genetic mapping company 23andMe is relaunching their specialized tests that offer to provide personal data on 36 diseases.
Mountain View, California, based company 23andMe Inc. was ordered by the FDA to stop selling specialized genome health related tests directly to consumers in 2013, indicating that the products had not been properly cleared for diagnosis of disease and may not be scientifically sound.
Recently, the FDA offered the company clearance to sell the test again, with several modifications to which disease information could be included. With the FDA go ahead, 23andMe is relaunching their direct-to-consumer genetic test.
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The test, where consumers spit in a vial to have their saliva analyzed, provide information on whether an individual carries a genetic variant for one of 36 rare diseases that could be passed on to children. The test also provides information on “wellness” traits, including a predisposition to lactose intolerance.
The company was warned by the FDA in 2013 not to sell the test. Officials say the agency was worried consumers would receive false results which could lead to consumers undergoing unnecessary medical procedures. In addition, the FDA said some consumers may not understand the results of the tests without the help of a doctor or genetic counselor to interpret the data.
Despite the misgivings, after some tweaking, the company has relaunched its direct-to-consumers test. In February, the FDA approved the test for a rare disease known as Bloom syndrome. The kit would also test for cystic fibrosis and sickle cell anemia.
In order to gain FDA approval, 23andMe hired an expert in dealing with FDA regulators. The company continued to sell the test in the interim, but only offered data on a customer’s ancestry.
The FDA would not let 23andMe to provide genetic information about Alzheimer’s disease or breast cancer. They would also not approve the company to test for adverse reactions to certain drugs. There is no timetable for when the company will offer more disease assessments or drug interaction data.
This information was previously provided to customers before the FDA ordered the company to stop. The test previously cost $99 and is now being sold for $199.
The FDA was also concerned the company was marketing the kit as a tool for assessing the risk of disease. The agency also admonished the company for failing to respond to FDA warnings in timely manner.
Many proponents say consumers should have the choice to get genomic information through a physician or through direct-to-consumers tests. Critics and the FDA are concerned the data may be overwhelming for many people who may not understand complicated genetic information.
More than 1 million people have purchased the test since it was launched in 2007 and has tested for 650,000 different genetic variations.
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