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N9

Peptides for the differential diagnosis of Ulcerative Colitis and Chrohn's Disease

Prof. Margherita Morpurgo, University of Padova; Prof. Giacomo Carlo Sturniolo, University of Padova; Dr Sonia Facchin, University of Padova; Dr Libona Digiglio, University of Padova; Dr Renato D'Incà, University of Padova; Dr Andrea Buda, University of Padova

University of Padova


Challenge

To provide doctors an effective (highly specific and sensitive) and convenient diagnostic tool for distinguishing ulcerative rectocolitis (UC) from Crohn’s disease (CD) in patients with indeterminated inflammatory bowel disease (IBD), in order to administer the right therapy.


Technology

We identified two peptides able to recognize selectively biopsies of inflamed mucosa of either CD or UC patients. We developed an ELISA-like or a fluorescent based test capable to discriminate between the two clinical conditions using patient colonoscopy biopsies. The method complements and expands the diagnostic armamentarium in IBDs, especially when discrimination between these CD and UC is not straightforward. In detail, we developed:

1. a peptide (peptide 1) with the ability to bind inflamed UC patient biopsies but non CD ones;

2. a peptide (peptide 2) with the ability to bind inflamed CD patient biopsies but non UC ones;

3. a method comprising the use of peptide 1 with the ability to discriminate UC from CD with 88.5% specificity and 76.9% sensitivity;

4. a method comprising the use of peptide 2 with the ability to discriminate UC from CD with 88.9% specificity and 100% sensitivity;

5. a method comprising the combined use of peptides 1 and 2 with the ability to discriminate UC from CD with 100% specificity and 100% sensitivity.


Commercial Opportunity

Discrimination between Crohn Disease (CD) and Ulcerative Colitis (UC) is an unsolved clinical issue in up to 10-15% of inflammatory bowel disease (IBD) patients (in industrialized countries CD+UC IBD patients are about 6.5 million). The combined use of the two patents constitutes the basis for the creation of a diagnostic kit applicable to all IBD patients. Early stage accurate diagnosis will provide patients with correct therapies, reduce disease morbidity and reduce costs. The test may become an important asset for any in vitro diagnostics (IVD) company interested in the inflammatory bowel disease market.


Development Status

The method has been validated on about 100 patients.


Patent Situation

Italian priority applications and PCT applications filed


Further Reading

Facchin S., Digiglio L., D’Incà, R., Casarin E., Dassie E., Dettin M., Zamuner A., Buda A. De Boni M., Della Libera D., D’Urso A., Sturniolo G.C. and Morpurgo M. (2017) Discrimination between Ulcerative Colitis and Crohn’s Disease using Phage Display identified Peptides and Virus-mimicking Synthetic Nanoparticles, Nanomedicine: Nanotechnology, Biology, and Medicine, doi: 10.1016/j.nano.2017.04.007


 

Peptides for the differential diagnosis of Ulcerative Colitis and Chrohn's Disease