BURLINGTON, N.C.– Labcorp (NYSE: LH), a leading global life sciences company, is the first U.S. commercial laboratory to offer a new test developed by Immundiagnostik, Inc. to help individuals detect and quantify unintentional gluten consumption.
As awareness of celiac disease and non-celiac gluten sensitivity (NCGS) increases in the United States and around the globe, more people are adhering to strict diets to avoid gluten exposure and the negative effects it can have on their health.
Avoiding gluten can be challenging. With no widely available method to accurately identify and measure gluten in products such as food, supplements and medications, it is often difficult to determine successful adherence to a gluten-free diet. Products branded as gluten free may actually contain enough gluten to trigger a reaction. In one study of celiac patients on a gluten-free diet, 67% of participants with persistent symptoms had detectable levels of gluten in their stool samples. This highlights the importance of testing, which enables individuals to understand the extent of an unintended gluten exposure and better identify the food or consumable product that may have caused their symptoms.
“For people with celiac disease and other gluten sensitivities, accidental gluten consumption can occur even when attempting strict adherence to a gluten-free diet—making testing an essential part of any attempt to remain symptom free,” said Dr. Marcia Eisenberg, chief scientific officer of Labcorp Diagnostics. “Labcorp’s innovative, newly offered test option goes beyond a simple confirmation of recent gluten exposure by measuring the amount of gluten detected in a person’s stool sample. This gives health care providers and their patients additional information to guide dietary decisions to help reduce gluten consumption, as well as the impact resulting symptoms have on patients’ lives.”
Gluten intolerance conditions often go undiagnosed and can have serious ramifications for those unaware of the cause of their symptoms. One of those conditions, celiac disease, is an autoimmune disease caused by a response to gluten-containing dietary items in individuals genetically predisposed to the condition. Celiac disease is estimated to affect about 1% of people in the United States, and its prevalence is rising. NCGS—implicated in people with a gluten intolerance when celiac disease, wheat allergy and other causes of symptoms are ruled out—is thought to be more common. Currently, the only treatment option for celiac disease is lifelong, strict adherence to a gluten-free diet. For NCGS, treatment is based on a gluten-free diet. However, as the condition can be transient, strict and long-term avoidance may not be necessary.
The new, quantitative test offered by Labcorp detects the presence of gluten in a patient’s stool sample and has a high sensitivity and specificity. Unlike other products for monitoring unintended exposure, the test measures the amount of gluten detected in a sample. In addition, physicians may use the test to help in the assessment for true “refractory” celiac disease by ruling out gluten exposure as a cause of the prolonged symptoms.
“Having the ability to confirm and measure unintended gluten exposure gives patients more control over their diets and their health,” said Marilyn Geller, CEO of the Celiac Disease Foundation. “Labcorp is the first clinical reference lab in the United States to offer a test that utilizes stool samples to directly quantify the disease-triggering source. This new option opens the door for more people across the country to better manage their celiac disease or NCGS.”
