Words by GOLD newsdesk
A new at-home genetic test for coeliac disease risk has received clearance from US regulators, making it the first of its kind to be authorised by the FDA.
The test, GlutenID, was developed by California-based firm Targeted Genomics and analyses genetic variants linked to coeliac disease, an autoimmune condition triggered by gluten consumption.
The technology works by sequencing DNA from a saliva sample collected at home. It then identifies key genetic markers and places users on a spectrum of risk. A negative result suggests a less than 1% chance of the person developing the condition in their lifetime. The company says the test is designed to be affordable, rapid and accessible for individuals and families seeking insight into their genetic predisposition.
“The root cause of celiac disease is genetic, but understanding celiac genetics is confusing for everyone, including physicians,” said Dr Shelly Gunn, Founder and Medical Director, Targeted Genomics. “Our task in developing GlutenID was to simplify the testing and interpretation of celiac genetics allowing anyone to know their inherited genetic risk for developing celiac-related gluten sensitivity.”
While the test does not diagnose the coeliac disease, it offers a starting point for those experiencing symptoms or with a family history of the autoimmune condition. Users are encouraged to discuss results with a healthcare professional before making dietary changes.
With FDA clearance secured, GlutenID marks a step forward in genetic risk screening for coeliac disease, offering an additional tool for individuals and families to assess their inherited risk.
