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USPTO has granted a patent to the CIGB for the first visual one-step assay to diagnosis and follow-up celiac disease.

José A. Acosta, Ernesto L. Mola, Ricardo S. Rodríguez, Boris E. Acevedo, Luis H. Martínez.

Havana - April 4. The U.S. Patent and Trademark Office has granted a patent to the Center for Genetic Engineering and Biotec hnology (CIGB), Havana, Cuba, claiming for the invention of a one-step immunochromatographic assay for screening and follow up of celiac disease. The novelty of this innovation consists of a simple15-minutes and highly accurate assay for diagnosis of celiac disease based on transglutaminase antigen. The CIGB is offering an out-license agreement to commercialize the strips into the US market.

According to a peer-reviewed paper published by Cuban scientists in Lancet 2002, 359 : 945-946, this test is highly accurate for detection of untreated patients with celiac disease and prevent misdiagnosis of patients with a deficit of IgA, a frequent trait of celiac disease. The assay can be done in a doctor's surgery, and seems to be a useful alternative way to screen for celiac disease, especially in patients with few or with untypical symptoms, and in risk groups, i.e. people with insulin dependent diabetes, Down's syndrome, autoimmune diseases, and first degree relatives of patients with celiac disease.

Celiac disease is caused by intolerance to gluten, which is found in wheat, barley and rye. It causes bloating, diarrhea, stomach pain, fatigue and weight loss. Damage to the intestine can lead to vitamin deficiency. The only remedy is to avoid foods such as breads, cereals and any other products that contain gluten. In a test of 90 people, by using the Cuban assay, it correctly identified 50 with celiac disease and produced negative results for those without it. The patent granted by the USPTO claims for the invention of a novel method for detecting IgA or IgG anti-transglutaminase antibodies in blood, plasma and serum samples. T his method is the easiest and fastest assay yet developed to detect anti-TG antibodies for celiac disease diagnosis. The only operation is to add the sample in the indicated place and wait out for the result of the test.

The CIGB has opened a project for negotiations to develop and commercialize a visual assay for anti-transglutaminase antibodies detection useful in celiac disease diagnosis, based on the general immunochromatographic assay principles. Competitive advantages of the CIGB to perform this project are: more than 15 years experience in diagnosis research and development, highly skilled staff and self-reliant laboratories. The project " Visual assay for anti-transglutaminase antibodies detection useful in celiac disease diagnosis" has been included within a project portfolio along with other 18 biomedical projects and published in the web site http://gndp.cigb.edu.cu , to facilitate the access of the medical community, companies and research institutions to the most up to date R&D results at CIGB.

For information: http://gndp.cigb.edu.cu or http://www.cigb.edu.cu

Contact: ernesto.lopez@cigb.edu.cu

Phone: (53-7) 2712397.

 
     
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