As 23andMe outlines on its website, the service now reports on consumers” “carrier status’, where being a carrier means a person has one variant for a condition but doesn’t have the condition, although the variant may be passed on genetically.
In a transparency report published Wednesday, the direct-to-consumer genetic-testing startup revealed that law enforcement officials have requested five customers’ data over the course of the company’s almost decade-long history.
23andMe is based in Mountain View, Calif. In the beginning the company offered consumers information on their risks of contracting various diseases based on an analysis of the DNA in a sample of their saliva.
“One concern about informing people that they have these types of carrier mutations is that people may not know how to process the information without help”.
23andMe, the company that benefited greatly with a few favor from Google, suffered a massive setback when the FDA stepped in and shutdown its genetic health screening service.
When the Food and Drug Administration banned 23andMe from marketing its direct-to-consumer genetic tests almost two years ago, the company became a cautionary tale of biotech companies: ignore regulators at your own peril. In the past, 23andMe provided customers with information about their risk of developing a range of diseases based on their DNA sample; now, it will just be able to provide information about the risk of passing a few inherited diseases on to children. For instance, if you and your partner both test positive for the faulty gene that causes Tay-Sachs or cystic fibrosis, your kids have a high probability-25% to be exact-of developing the disease. This is the same basic service that genetic counselors have been offering for a few time, but for much more than $199.
At the time, 23andMe’s literature said its tests provided “health reports on 254 diseases and conditions”, which could enable customers to “take steps toward mitigating serious diseases”, including breast cancer and diabetes. About eight months back, the U.S. regulatory has approved the 23andMe’s carrier screening test for Bloom’s Syndrome. She also cited laws that are already in place - such as the Genetic Information Nondiscrimination Act - to protect customers from discrimination based on genetic information.
“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.
23andMe is not the only personal genome testing company, but it is the best known and is considered to be one of Silicon Valley’s big success stories.
The company still provided ancestor-related information and raw genetic data but without interpretation, arguably the most valuable part of the service.
“There is legitimate concern from all quarters about whether people will understand or misunderstand complicated genetic information”, he said. Prior to the FDA-mandated end of disease reporting, 23andMe would show users the estimated likelihood they would develop a certain disease - specifically, how their risk compared to the general population.
