FDA Allows Marketing of First Direct-to-Consumer Tests That Provide Genetic Risk Information for Certain Conditions, Including Celiac Disease

Print Friendly, PDF & Email

23andMe has been approved by the FDA to offer direct-to-consumer genetic screening for a number of diseases, including celiac disease. While CDF applauds accessible, lower-cost, genetic screening for celiac disease, patients are strongly advised to share their results with their physician for medical guidance before taking any course of action.

Celiac disease is a serious, genetic, autoimmune disorder caused by an immune reaction to the ingestion of gluten. Although it is often thought of as a rare disease, researchers tell us that it affects 1% of the world population, or approximately three million Americans. That 1%, however, may be a gross underestimate. A recent study published in Gastroenterology indicated that as many as 3% of all adolescents in the Denver metropolitan area develop celiac disease between birth and age 15. More shocking is that only about 20% of all cases have been accurately diagnosed. We also know that approximately 40% of the American population has the genetic biomarker necessary to develop celiac disease, however, only a fraction of those with the genetic biomarker will ever develop the disease. The likelihood of developing the disease without the genetic biomarker is almost zero.

Celiac disease genetic screening is recommended for the following populations:

1) First-degree relatives (parent, sibling, child) of a patient with celiac disease. A negative 23andMe test for the genetic biomarker means that they will not develop celiac disease and, therefore, need not be tested every 2-3 years for celiac disease for the rest of their lives.

2) Individuals who have started a gluten-free diet to mitigate symptoms associated with celiac disease, but have not been tested for the disease. A negative test for the genetic biomarker can rule out celiac disease. If the individual tests positive, however, he/she should consult his/her doctor and discuss the impact of a serology test for celiac disease which would require undergoing a gluten challenge (two slices of wheat-based bread daily for 6-8 weeks).

3) Individuals who are considering a gluten-free diet because they suffer from symptoms associated with celiac disease. A negative 23andMe screen can rule out celiac disease before they remove gluten from their diet.

Read the full story here.

FDA Allows Marketing of First Direct-to-Consumer Tests That Provide Genetic Risk Information for Certain Conditions, Including Celiac Disease

Tags: , , , , , , ,