Biomarker-based assay for diagnosing non-celiac wheat/gluten sensitivity

This technology is a diagnostic assay for serologic biomarkers associated with non-celiac gluten/wheat sensitivity (NCGS/NCWS) in patients.

Unmet Need: Diagnostic tool for assessing NCGS/NCWS in patients

Celiac disease is a common autoimmune disorder that is characterized by an immune response to ingested wheat gluten. Some individuals, however, experience a range of symptoms in response to ingestion of wheat and related cereals, yet lack the characteristic serologic, histologic, or genetic markers of celiac disease. The terms non-celiac gluten sensitivity (NCGS) or non-celiac wheat sensitivity (NCWS) are generally used to refer to this condition, which is currently understood as the collection of symptoms in response to ingestion of gluten-containing foods. Currently, the pathogenesis of NCGS is not well understood, and there remains a need for biological biomarkers to aid in the diagnostics and monitoring of this condition in patients.

The Technology: Biomarker-based assay for assessing NCGS/NCWS in patients and monitoring treatment

This technology is a set of biomarkers that can be used to screen patients for NCGS/NCWS. This diagnostic method involves determining the levels of a combination of select markers found to be associated with NCGS/NCWS in a patient’s blood that may include soluble CD14 (sCD14), lipopolysaccharide-binding protein (LBP), anti-gliadin antibodies, and intestinal fatty acid-binding protein (FABP2) as indicators of NCGS/NCWS. As such, this technology provides not only a powerful diagnostic tool, but also an effective method for monitoring treatment of this condition.

This technology has been validated using serum from symptomatic individuals where wheat, rye, and barley intake were controlled.

Applications:

• Diagnostic assay for NCGS/NCWS
• Assessment of patient response to treatment
• Research tool for studying celiac disease and NCGS

Advantages:

• Establishes a panel of biomarkers
• Aids in definitive diagnosis of NCGS/NCWS
• Assesses the response of an individual to therapy

Lead Inventor:

Armin Alaedini, Ph.D.

Patent Information:

Patent Status

Related Publications:

• Uhde M, Caio G, De Giorgio R, Green PH, Volta U, Alaedini A. “Subclass profile of IgG antibody response to gluten differentiates non-celiac gluten sensitivity from celiac disease” Gastroenterology. 2020 Nov; 159: 1965–1967.

• Uhde M, Ajamian M, Caio G, De Giorgio R, Indart A, Green PH, Verna EC, Volta U, Alaedini A. “Intestinal cell damage and systemic immune activation in individuals reporting sensitivity to wheat in the absence of coeliac disease” Gut. 2016 Dec; 65(12): 1930-1937.

Tech Ventures Reference:

• IR CU16173

• Licensing Contact: Jerry Kokoshka