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Scientists at the University of Bonn, Germany, have identified the main target antigen for the atypical antineutrophil cytoplasmic antibodies pANCA in autoimmune liver disorders and chronic inflammatory bowel diseases. BT-50 can be produced by recombinant means and used for the quantification of atypical pANCA in serum probes.

So far, atypical pANCA have been detected on ethanolfixed neutrophils by indirect immunofluorescence microscopy. This complex and expensive method represents the "gold standard" by now.

In order to develop a simple screening method for atypical pANCA, there have been several attempts to establish an ELISA for use in any routine laboratory. Up to now the sensitivity of these commercially available test systems has always been less than 50%, irrespective of the used antigen (e.g. myeloperoxidase (MPO), cathepsin G, bactericidal/ permeability increasing protein etc.), as the responsible antigen was unknown up to the present.

Now that BT-50 has been identified as the main target antigen for atypical pANCA, highly specific solid phase tests, e.g. ELISA, can be established for the detection of atypical pANCA. In contrast to immunofluorescence microscopy, ELISA tests can be easily performed in routine laboratories. Pivotal clinical studies have revealed that BT-50 is reactive with more than 93% of all atypical pANCA-positive sera.

Commercial Opportunities

While classical pANCA are serum markers for systemic vaculitides, atypical pANCA (also known as pANCA or xANCA) are associated with autoimmune hepatitis, primary sclerosing cholangitis, and chronic inflammatory bowel disease, such as ulcerative colitis and Crohn's disease. At the moment, only elaborate and costly diagnostic tests are available for detecting atypical pANCA. BT-50 opens up the chance to establish a simple and reliable kit for routine laboratory use.

Competitive Advantages

• Suitable for establishing a routine diagnostic test recognizing >93% of pANCA-positive sera 
• Recombinant production of main antigen 
• Less complex and highly specific compared to conventional test systems 
• Ready to be investigated in vivo 
• Further scientific and clinical collaboration possible 
• IP-protection in USA and Germany

This technology is offered by PROVendis the transfer office of the state of Northrhine-Westfalia.  

Contact

Kordula Kruber, Dipl.-Biol.
Tel.: +49(0) 208/94105-30
kk(at)provendis.info

About PROvendis

PROvendis offers companies certified and patented innovations from 24 North Rhine-Westphalian universities. The core function of the enterprise is to market patentable and commercially exploitable inventions. PROvendis GmbH was founded in 2001 as a wholly owned subsidiary of Zenit GmbH, a management consultancy firm in cooperation with the state of North Rhine-Westphalia. Since January of 2002, PROvendis has been the service provider for the universities of the state of North Rhine-Westphalia. Within the scope of the BMBF commercialization campaign, the Federal Ministry for Education and Research (BMBF) supports the activities of PROvendis.

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