Human guanylate binding protein-1 (GBP-1) ELISA

Reference Number TO 01-00330

The Challenge

In many conditions diagnosis as early as possible is important for the outcome of the disease by helping to take appropriate measures very early, e.g. determining a therapy regimen in disease progression. In some cases early diagnosis is essential for survival of the patient. Inflammatory processes and tumor diseases have to be diagnosed as early as possible, best before onset of clinical symptoms to achieve successful treatment.

GBP-1 is a marker protein for inflammatory reactions which is secreted, inter alia, by endothelial cells and monocytes. GBP-1 characterizes endothelial cells exposed to inflammatory cytokines in vitro and in vivo and mediates potent anti-angiogenic effects of these cytokines.


	Description of illustration Source: www.medizin.fu-berlin.de

The Technology
The invention discloses an ELISA specific for a protein which expression is early and tightly regulated exclusively through specific inflammatory parameters. Inflammatory processes, sepsis and intoxication with bioterrorism agents like Staphylococcus Enterotoxin B cause upregulation, AIDS-progression causes downregulation of this protein. Changes in the protein´s expression pattern allow early diagnosis of the conditions mentioned.

Commercial Benefit and Opportunity

The world market for in vitro diagnostics is one of the fastest growing markets and is estimated to reach a volume of US$34 billion in 2007 and is expected to grow around 9% annually. ELISA based kits alone account for approximately 12% of the global market.

Advantages of the invention are:

· novel diagnostic tool: quantitative ELISA of secreted GBP-1 specific for severe and/or life threatening conditions serves as disease-associated parameter/marker

· fast and early diagnosis, ideally before the appearance of first clinical symptom

· cost effective compared to other methods, e.g. RT-PCR

License is being offered world-wide on a co-exclusive basis for the diagnostic market.

Developmental Status

Proof-of-principle has been demonstrated using clinical samples (serum, liquor) from patients with inflammatory processes caused by different diseases (e.g. rheumatoid arthritis, lupus erythematodes, systemic sclerosis, bacterial meningitis). In addition, GBP-1 had been shown to have an impact on survival and perspectives for antiangiogenic therapy in colorectal carcinoma.

Patent situation

An US patent is issued (7,498,144), patent applications are pending in EP, CA and JP.

Relevant Publication

Naschberger et al. (2008), Int. J. Cancer 123, 2120-2129; Naschberger et al. (2006), Am. J. Pathol. 169, 1088-1099; Lubeseder-Martellato et al. (2002), Am. J. Pathol. 161, 1749-1759.