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Immunologic Activity Measure(s) for T ‘Helper’ One Diseases

Organization:Boston University, MA, US
I.P. Brief:This invention measures immunologic activity of T \'helper\'1 (Th1) diseases. The test provides data to clinicians to assit them in monitoring and maintaing chronic inflammatory diseases such as Crohn\'s disease, rheumatoid arthritis, lupus and solid organ transplant rejection
Summary of I.P.:The test is in ELISA format that measures pro-inflammatory chemotactic cytokines CXCL9 (MIG), CXCL10 (IP-10) and CXCL11 (ITAC, I-TAC) levels in the blood. By tracking the levels of these chemokines over time and comparing to a patient’s relative disease state, a clinician can more precisely control dosing of immunosuppressive medications. Human data has been generated and additional samples are being tested. The test would be administered by the patient\'s themselves, in much the same way diabetes patient\'s monitor their insulin levels. Individual\'s, with their clinician, would monitor their chemokine levels and determine the appropriate type and amount of immunosupressive medications
Patent:U.S. utility pending
Keywords:diagnostic, inflammatory disease, Crohn\'s disease, ELISA
Primary Industry:Pharma & Biotech
Specific Market:Medical diagnostics
Market Size:500,000 Crohn’s disease sufferers in the U.S. 2.5 million with rheumatoid arthritis. 1.9 million in the U.S. with Lupus and tens of thousands of solid organ transplants every year. Thus the number of patients who would benefit from this monitoring test
State of the Art:Currently, there are non-specific inflammation-associated blood tests available, such as the erythrocyte sedimentation rate (ESR) or c-reactive protein (CRP. These tests are not clinically useful as they do not change management or cannot be used as an accurate measure of immune system modulation.
Competition:Educating clinicians to use this new data; explaining to potential licensees (diagnostic companies) that there is not a clinically relevant reference range as the data are particular to each patient and his or her disease, and a skilled clinician will be able to use the information to improve care.
Figures of Merit:This test will help clinicians and patients manage chronic diseases. This will lead to more efficacious dosing, resulting in better disease management (flare-ups anticipated, drug effectiveness monitored), fewer drug side effects (powerful steroids are used), and fewer hospital admissions and surgeries. This will lead to savings for HMO’s.
Tech.  Obstacles:There are no key technical obstacles
Market Obstacles:A large, multi-center, longitudinal clinical study is required.
Patent Landscape:PCT/US04/026236, which has entered the national phase in the US only. Other intellectual property which may be needed includes IP around the individual chemokines selected for measurement and perhaps components that will be incorporate into the ELISA kit.
Publications:No publications to date, beyond abstracts for meetings.
Research Team:Dr. Francis Farraye, Associ. Professor, Gastroenterology, BUSM Dr. Lawrence Saubermann, Assoc. Prof of Medicine, University of Rochester Medical Center Dr. Farraye has an ongoing practice, focusing on Crohn\'s patients while Dr. Saubermann\'s laboratory focuses on developing and analyzing the clinical samples.


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