The recent FDA clearance of the GlutenID genetic test has sparked discussion about its role in celiac disease screening. Celiac disease has a strong genetic component, and screening is generally recommended for first-degree relatives of individuals with celiac disease. An over-the-counter genetic screening test, like GlutenID, could help identify those who carry genetic markers associated with celiac disease, providing useful information for at-risk individuals and their healthcare providers. While the test meets high technical standards and provides over-the-counter (OTC) access to genetic risk assessment for celiac disease, it is important to clarify its utility in diagnosing celiac disease.
Celiac disease typically develops in early childhood. As Robert Anderson, MB ChB PhD, Principle Science & Innovation Advisor to the Celiac Disease Foundation explains, “Celiac disease onset is in early childhood and rarely in adults. In fact, the median age of onset in prospective observational studies of at-risk children, like the TEDDY study, is around 2–3 years of age and rarely beyond 7 years”. Because of this, screening with serology tests at age 12 could identify most individuals who would otherwise be diagnosed in adulthood.
At home genetic tests, like GlutenID, can determine if someone carries genes associated with celiac disease, but it does not diagnose the condition.
“Serology and not genetics is currently the preferred screening test for celiac disease in individuals regularly eating gluten. While genetic testing can be useful in specific situations, such as ruling out celiac disease in people who are already gluten-free, it is not a replacement for traditional diagnostic tools like antibody tests and biopsies,” says Dr. Anderson.
Ultimately, while OTC genetic tests like GlutenID may empower consumers to take an active role in their health, diagnosis by a physician i crucial for accurate diagnosis and treatment.