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The 23andMe personal genomics company is now offering a home kit to test the risk of type 2 diabetes, although the disease has long been linked to environmental factors.
However, the new offer identifies people with a genetic predisposition to type 2 diabetes, and the goal is to encourage people at risk to adopt a healthier lifestyle change.
The report is the latest in a series of home DNA test kits that cover the risks of developing various conditions such as lung / liver disease, bad and ovarian cancer, and disease. late Alzheimer's.
Kits, which only require a saliva sample to generate the results, can also provide a carrier status report for a list of diseases including cystic fibrosis, sickle cell anemia and hereditary hearing loss.
Although the type 2 diabetes report differs slightly from the company's prototypes, it has been fueled by the research of more than 2.5 million of its clients via an opt-in data collection service.
Based on these data, scientists have developed a polygenic score based on more than 1,000 genetic variants to calculate the likelihood that a client develops type 2 diabetes. The score is not based solely on predispositions because it takes into account other factors such as weight and age.
"Diabetes is a major health problem in the United States that is expected to affect nearly half of the population. When clients discover their genetic probability of developing type 2 diabetes, we believe that there is an opportunity to motivate them to change their lifestyle and help them prevent the disease, "said Anne Wojcicki, CEO and co-founder of 23andMe.
The company has confirmed that it did not seek FDA approval this time, but has complied with the general drug policy's wellness policy, which provides tips on technologies such as fitness trackers or mobile apps.
With the recent explosion of digital tools that allow patients to take greater responsibility for their health, there are concerns about how to regulate these technologies to ensure their safe use.
However, the FDA has confirmed that it does not intend to actively regulate technologies such as the 23andMe test kits, as they are considered low risk, but it would continue to focus its efforts on medical devices likely to present an inherent risk to the safety of the user.
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