Silicon Valley DNA testing company 23andMe has announced a new test meant to identify genetic risk for Type 2 diabetes, expanding its health products to one of the country’s most widespread chronic conditions.
More than 30 million American suffer from diabetes and Type 2 diabetes is the most common form of the disease, making up 90 to 95 percent of the patient population.
According to the CDC, an additional 84 million Americans have prediabetes, which can lead to Type 2 diabetes within five years. The chronic condition is also expensive, with the total annual costs of diagnosed diabetes sitting at $327 billion.
“Diabetes is a significant health issue in the United States that is expected to impact nearly half of the population,” 23andMe CEO Anne Wojcicki said in a statement. “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.”
It would stand to reason that 23andMe could highlight genetic risks for the disease, in addition to the lifestyle and environmental factors that also contribute to developing the condition. But some experts are skeptical about the assessment’s potential health benefits.
The new Type 2 diabetes report differs from other 23andMe health tests because it was developed and validated from company’s internal research data of more than 2.5 million customers.
The company used this data set to create a polygenic risk score, a calculation based on genetic variants, which is tuned with specific demographic information from the participant.
One problem? Genetic testing databases tend to skew towards those with European ancestry, which poses particular problems for a condition like Type 2 Diabetes where incidence of the disease vary widely among people with different racial and ethnic backgrounds.
A study published in Genome Biology found that while people of European descent make up less than a quarter of the world’s population they made up more than three-fourths of the participants in genome-wide association studies, which help scientists determine genes involved with human disease.
“While I’m proud to help bring more diversity to 23andMe’s database and the research industry more broadly, our health product currently has limited utility for non-European customers (which includes me and my family),” 23andMe Vice President of Research Joyce Tung wrote in a STAT column.
In contrast to 23andMe’s previous FDA approvals for genetic risk tests for conditions like Alzheimer’s, Parkinson’s Disease and colorectal cancer, the diabetes assessment did not go through the FDA clearance pathway because it was characterized as a wellness product not intended to make diagnoses and provide medical advice.
Ironically, the FDA previously slapped down 23andMe’s efforts to offer unregulated health prediction tests – including one for type 2 diabetes – because of concerns about their accuracy and clinical validation.
The company’s new diabetes risk report comes with a disclaimer that the assessment “does not diagnose any health conditions or provide medical advice ” or “predict your personal overall likelihood of developing type 2 diabetes.”
That has led some clinicians to question its actual ability to improve health, especially since risk factors for Type 2 diabetes have long been known, but creating lifestyle changes have continued to pose a challenge.
There has also been criticism of how 23andMe pitches its business partner and chronic disease management company Lark Health’s service as a way for users to manage their condition.
“Based on current evidence, it not clear how customers and docs will use this data. In particular it’s not clear that learning genetic risk helps people “get active,” “eat healthy,” or stop smoking—the steps 23andMe recommends those at elevated risk take,” Peter Kraft, a professor at Harvard T.H. Chan School of Public Health, wrote in a tweet.
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