U.K. residents interested in finding out their genetic health risks for diseases like Alzheimer's, breast cancer and dozens of other conditions will now have the option to purchase a home genetic testing kit from the U.S.-based company 23andMe.
Officials from the U.K.'s Medicines and Healthcare Products Regulatory Agency say they support the use of commercial genomic testing to help patients become better informed about their health and future medical decisions. However, U.K. health officials said the kits should be used with some caution.
The decision is in stark contrast with the U.S. Food and Drug Administration's stance. Last November, the FDA issued an order telling 23andMe to halt sales of the kits for the purpose of genetic testing.
The company is still permitted to sell the DNA analysis kit in the U.S. market as a tool to collect information about ancestry, but it can no longer provide health reports based on a person's genetic makeup. More than 500,000 Americans were genotyped through 23andMe before the FDA issued the ban.
Catherine Afarian, a spokesperson for 23andMe, told CBS News that due to the regulatory restrictions in the U.S., the company is not at liberty to discuss the details of the news with members of the American press. However, the company did issue the following statement:
"23andMe's health reports are not cleared by the FDA and can only be purchased in the U.K. by U.K. residents. U.S. customers may purchase 23andMe's ancestry-only product, which provides access to their uninterpreted raw genetic data."
Customers in Britain can purchase the kits for 125 pounds (approximately $150) and send in a sample of their saliva for analysis. When it was available in the U.S. for health assessment, the kit cost $99, and it is currently available for that price to customers who wish to use it to explore their ancestry.
When used for the purpose of generating a health-related report, the kit can provide information on risks for more than 100 diseases and conditions, including gene mutations linked to life-threatening illnesses such as Parkinson's disease and breast cancer. As a health assessment tool, the kit also provides information on gene carrier status and medication sensitivities.
A letter sent by the FDA to Anne Wojcicki, CEO of 23andMe, last November said that because the product can be used for the purpose of diagnosing diseases and other health conditions, it falls under the agency's profile of a "device" that requires marketing clearance and approval by the FDA. The company would need to provide further evidence establishing the accuracy of the test results to win FDA approval.
Some experts in the genetic and biotechnology field believe 23andMe's efforts to expand the market overseas may be part of a strategy to put pressure on the FDA to lift the ban on sales in the U.S.
Critics say using the kit for health assessment opens up the possibility that customers may make health care decisions based on genetic risks they don't fully understand, or pursue extreme and unnecessary measures such as undergoing prophylactic surgeries.
Dr. Marcy Darnovsky, executive director of the Center for Genetics and Society in California told the BBC that a number of outside factors determine whether a person will develop a disease even if the home genetics test indicates they are at higher risk for a certain illness.
"Genetic testing is an important medical tool in certain situations, but for healthy people as a way to predict common complex diseases, it's pretty useless," Darnovsky told BBC News.