DEERFIELD BEACH, Fla.--(BUSINESS WIRE)--Although only an estimated 1% of the US population has celiac disease, millions more, 11% of US households, eat gluten free. Celiac is an autoimmune disease whereby the immune cells attack the lining of the small intestine, resulting in malabsorption and greater risk of diabetes and other autoimmune disorders. Strict avoidance of gluten is mandatory for people with celiac disease.
But, millions of people believe they suffer from gluten sensitivity, also known as Non-celiac gluten sensitivity; or NCGS. Until recently, the diagnostic criterion for NCGS was if you felt better avoiding gluten then you had NCGS. Physicians and scientists working in the field became concerned that this simple criterion was prone to subjective evaluation and conditioning; i.e., the placebo effect, and could cause many people to unnecessarily avoid an otherwise nutritious food staple.
Thus, they established the double-blinded placebo-controlled oral challenge, as the standard diagnostic criterion for NCGS; or, DBPCOC, for short. If you think the name is formidable, try following the procedure itself. Although reliable, the procedure is too cumbersome and time consuming to be used in routine clinical practice.
Hence, clinicians were eager to find a simple test that would correlate with the oral challenge. Today, researchers at the San Mateo Hospital at the University of Pavia (Italy) led by Dr. Michele Di Stefano, report in the December issue of Clinical Nutrition ESPEN, they have found such a marker. The title of their paper is, Non-Celiac Gluten Sensitivity in patients with severe abdominal pain and bloating: The accuracy of ALCAT 5. The name connotes use of the ALCAT test® developed by Cell Science Systems, in Deerfield Beach, FL; used in this study to measure the immune cell response, in vitro, to challenge with 5 gluten containing grains.
The question was, Does an immune cell reaction that occurs in the test well, in response to gluten exposure, such as it does in the Alcat test, reflect an immune cell response that occurs in the body? The answer, according to the Pavia researchers, is, yes. The Alcat test was every bit as accurate at predicting a sensitivity to gluten challenge or placebo, in their study population consisting of 25 subjects, as was the double-blind placebo-controlled oral challenge. According to the authors the DBPCOC is a lengthy and cumbersome procedure with lower patient compliance, whilst the Alcat test is simple to perform and results are rapidly obtained. Hence, since the results are similar, the Alcat test might represent a better and less costly alternative.
About Cell Science Systems, Corp.
CSS is a CLIA licensed lab and an FDA registered Medical Device establishment, that has developed the Alcat test for food and chemical sensitivities, as well as GI function assays, Telomere length assessments, molecular diagnostics, and, in January of 2019 will also be launching cellular tests for the assessment of functional micro-nutrient deficiencies and anti-oxidant status. CSS received the company of the year award in 2016 for Food Intolerance Testing, North America, by Frost & Sullivan. The Alcat test has been clinically validated in clinical research at the Yale School of Medicine where mechanistic studies were also conducted which have led to new discoveries regarding the pathogenic mechanisms underlying food sensitivities. CSS will continue to participate in industry grant-funded, cross border, translational research that focuses on the role of food induced release of DNA and its role in pathology. CSS is located in Deerfield Beach, FL and Potsdam, Germany.