Ulcerative colitis and Crohn’s disease are inflammatory bowel diseases that affect about 1% of the world’s population, especially young adults and children. These diseases are severe, chronic and often lead to complications such as cancer. Symptoms are often alike, are common to other benign diseases that affect about 30% of the population. This causes a delay in diagnosis in many cases: the tests that are available today aren’t specific for the disease and require lengthy processing.
My team at the University of Padua has developed a new lab test so that patients get the right treatment, and no precious time and money are wasted. All it takes is a stool sample. Any lab equipped with a MALDI TOF analyzer can quickly and automatically analyze a large number of samples in a short time. Thanks to the innovative algorithm that can identify the specific profile for each disease, doctors can now rely on a fast, precise result, and patients can forget painful, invasive tests.
The number of people in Industrialized countries that are affected by IBDs is on the rise: (diagnostics will play a crucial role in rationalizing the burden of therapeutic costs on our health care systems).
We’re seeking a leading international medical diagnostic company to bring this tool to hospitals and labs worldwide: our successful prospective phase has proven this technology to be ready for certification. This diagnostic method is covered by an international patent application.
Patent Status
DEPOSITATO
Priority Number
IT102018000005689
Priority Date
24/05/2018
License
INTERNATIONAL
Market
Since UC and CD are chronic, treatment costs per patient are high and burden healthcare systems. Better diagnosis with this inexpensive test will help to not waste precious time and money on improper treatments.
This patented test covers the same market area as faecal calprotectin.
This translates into an estimate of around 5000 tests per 100,000 inhabitants per year, a number destined to grow in the near future.
Problem
Crohn’s disease (CD) and Ulcerative colitis (UC) are the two main Inflammatory bowel diseases (IBDs), whose onset occurs mainly in adolescents and young adults, although in 20-25% of cases they first appear in childhood. Despite low prevalence (approximately 1%), IBDs represent a relevant healthcare problem, because they are lifelong diseases with a chronic course, characterized by flares and remissions, and complications such as stenosing and/or fistulizing in CD (16% of patients) and increased colorectal cancer risk, especially in UC. At onset symptoms are often aspecific, and this could lead to an underestimation of the disease for a long time, thus worsening prognosis. Moreover in a subset of cases is not easy to distinguish CD from UC, which might share clinical, imaging and histologic patterns. The current lack of precise and reliable diagnostic tools makes it difficult to carry out a specific and timely diagnosis, necessary to mitigate complications and decrease the chances of developing colorectal cancer over time. Since IBDs are chronic diseases, they require continuous monitoring to verify not only the stages of remission and exacerbation, but also the response to drug treatment.
With this test method it will be possible to offer a more sensitive, specific and reliable diagnostic kit based on faecal markers for the correct diagnosis of IBDs.
Current Technology Limitations
The clinical symptoms of IBD often overlap those due to irritable bowel syndrome, a functional syndrome very common in the population (about 30%). Non –invasive screening of subjects with abdominal symptoms (swelling, diarrhea or constipation, abdominal pain) currently makes use of the determination of faecal calprotectin, which has significant limitations in specificity, since it increases in the presence of any cause of gastro-intestinal inflammation (e.g. drugs such as NSAIDs or PPIs, infections, intolerances or food allergies).
Currently the diagnosis of IBDs are carried out on the basis of the results of a complex set of invasive instrumental (e.g. entero-MRI), endoscopic (e.g. colonoscopy) and histological investigations.
This approach does not always distinguish the two main IBDs, Crohn's disease and Ulcerative Colitis, which need a different pharmacological and surgical treatment.
The only non-invasive laboratory tests useful for diagnostic purposes are faecal calprotectin, serum antibodies to Saccaromices cerevisiae (ASCA) and anti-neutrophil cytoplasm (pANCA).
However the sensitivity and specificity of these tests does not exceed 75%.
Killer Application
The key applications of this technology are:
• Diagnosis of Inflammatory Bowel Diseases from faeces
• Possibility of distinguishing with a high specificity rate Crohn's disease from Ulcerative colitis
Our Technology and Solutions
This highly automated analytical system can obtain a diagnostic peptidomic profile for IBDs from a faecal sample using MALDI-TOF / MS mass spectrometry. Starting from a small amount of stool (about 100 mg), of any consistency, the system uses a limited number of simple and quick pre-analytical steps: dilution, extraction of proteins, desalination and preparation of the MALDI plate.
The peptidomic analysis can be performed on any MALDI-TOF / MS instrumentation equipped with the reflectron mode, even on the bench. The peptidomic profile generated by the patented algorithm will be classified automatically to detect not only the presence or absence of IBDs, but also to distinguish Crohn's disease from Ulcerative colitis. The diagnostic performance of this analytical system, already in the advanced validation phase, is higher than that of faecal calprotectin: in fact the sensitivity of this test is 81% vs 78% and the specificity 97% vs 65%.
Advantages
This technology allows an early and differential diagnosis between the different types of intestinal inflammation. A correct and early diagnosis of the IBDs will reduce time and costs for treatment.
The initial investment costs for MALDI-TOF / MS mass spectrometry instrumentation can be quickly amortized considering the very low cost of the reagents and consumables necessary for each analysis. Sample processing can be easily automated.
Specifically the technology:
Does not require biopsy or other invasive techniques because it relies on any faecal sample;
Identifies specific biomarkers for Ulcerative Colitis and Chron’s disease;
Low analytical cost;
Fast results;
Potentially widespread application because it is based on common MALDI-TOF / MS mass spectrometry.
Roadmap
Validation and production of a marketable diagnostic kit will require further investments, specifically:
Further prospective phase analysis.
Implementation of an automated platform for stool preparation, which could be used in the future also for other fecal tests.
Regulatory/Certification
Marketable kit requires a company for production (raw material, packaging) and distribution.
TRL
Il team
