The gene company 23andMe now offers homemade equipment for testing the risk of type 2 diabetes, although the disease has long been associated with environmental factors.
However, the new offer identifies those who carry a genetic predisposition for type 2 diabetes, and the company says the goal is to encourage those at risk to adopt a healthier lifestyle change.
The report is the latest in a series of homemade DNA test kits, which covers the likelihood of a large number of diseases such as lung / lung cancer, breast and ovarian cancer, and late-onset Alzheimer's disease.
Collections requiring only a sample of saliva to generate results can also provide a report on the status of carriers for a list of diseases, including cystic fibrosis, sickle cell anemia, and hereditary loss of hearing.
Although the type 2 diabetes report differs little from the prototype of the company, as it is powered by research of more than 2.5 million of its ready-made customers through the data collection service.
Using these data, scientists developed a polygenic score that attracted more than 1,000 genetic variants to calculate the client's likelihood of developing type 2 diabetes. The result is not based solely on genetic predispositions alone, as it takes into account other factors such as weight and age.
"Diabetes is a major health issue in the United States, which is expected to affect almost half of the population. When customers learn about their genetic probability of developing type 2 diabetes, we believe that there is a possibility to motivate them to change their lifestyle in ultimately to help prevent the disease, "said Ana Vojutchski, executive director and co-founder of 23andMe.
The company confirmed that it did not seek approval from the FDA this time, but it followed the general drug policy regulator, which is a document that provides guidelines for technologies such as fitness goggles or mobile applications.
Since the recent explosion of digital tools that allowed patients to take more control over their health, there are concerns about how to regulate these technologies to ensure they are safe to use.
However, the FDA has confirmed that it has no intention of actively regulating technologies such as 23andMe's test kits because they are considered to be low risk but will continue to focus their efforts on medical devices that may pose a safety risk to user.