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23andMe to offer type 2 diabetes testing kit

New report is powered by data from the company’s customers


Personal genomics company 23andMe is now offering an at home kit to test the risk for type 2 diabetes, despite the disease having long been linked to environmental factors.

However, the new offering identifies those who carry a genetic predisposition for type 2 diabetes, and the company says the aim is to encourage those at risk to adopt a healthier lifestyle change.

The report is the latest in a string of at home DNA testing kits, which covers a person’s likelihood of developing a range of diseases such as lung/liver disease, breast and ovarian cancer and late-onset Alzheimer’s.

The kits, which only requires a saliva sample to generate the results, can also provide a carrier status report for a list of diseases including cystic fibrosis, sickle cell anaemia and hereditary hearing loss.

Although the type 2 diabetes report slightly differs from the company’s prototypes as it has been powered by research from more than 2.5 million of its willing customers via an opt-in data collection service.

Using this data, scientists have developed a polygenic score that drew on more than 1,000 genetic variants to calculate a customer’s likelihood of developing type 2 diabetes. The score isn’t just based on genetic predispositions alone as it takes into account other factors such as weight and age.

“Diabetes is a significant health issue in the United States that is expected to impact nearly half of the population. When customers learn about their genetic likelihood of developing type 2 diabetes, we believe there is an opportunity to motivate them to change their lifestyle and ultimately to help them prevent the disease,” said Anne Wojcicki, CEO and Co-Founder of 23andMe.

The company has confirmed that it hasn’t sought approval from the FDA this time, but it has followed the medicines regulator’s general wellness policy, which is a document that provides guidance on technologies such as fitness trackers or mobile apps.

Since the recent explosion of digital tools that has allowed for patients to take more control of their health, there has been concerns on how to regulate these technologies to make sure they are safe for use.

However, the FDA has confirmed that it does not intend to actively regulate technologies such as 23andMe’s testing kits as they are considered low risk, but will continue to focus its efforts on medical devices that may pose inherent risks to a user’s safety.

Article by
Gemma Jones

12th March 2019

From: Regulatory



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