Bladder cancer is a common cancer, with over 429,000 new cases diagnosed globally in 2012, and it is an expensive cancer, costing the UK alone over £50 million per year. Currently, the gold standard diagnosis and management tool for bladder cancer is cystoscopy, which is expensive, uncomfortable and carries a risk of infection. Because of the high recurrence rate of bladder cancer (up to 35% in the first 3 years), these shortcomings are exacerbated by the need for repeated surveillance, which may extend to quarterly cystoscopies for 1-2 years post-surgery, every 6 months in year 3-4, and annually thereafter.
By transforming urine cytology, a complementary adjunct to cystoscopy, Cytosystems is developing technology to reduce the number of cystoscopies required for bladder cancer patients. The monoclonal antibody at the core of Cytosystems' assay is specific for minichromosome maintenance protein-2 (MCM2), licensed by Cancer Research Technology. Enabling technologies have been developed to create an integrated bladder cancer risk stratification package BladderLightTM. The three components of BladderLightTM are as follows, which correlate as the three aims of the project:
• A low-cost, single-use cell collection device which both preserves cells and optimises the quality of cell capture
• Patented MCM2 biomarker technology stain
• Digital imaging and diagnostic algorithms. The automated analysis highlights cancer cells for clinical viewing.
The first objective of the project is to design, evaluate, and manufacture pre-prototype devices, in conjunction with a specialist medical device design company. These devices will be subject to full clinical evaluation for regulatory purposes. Our results to date have been equivalent to the cell capture of centrifugation – the laboratory ‘gold’ standard. The final prototype will then be subject to a larger trial in 2017 as part of the full BladderLightTM package.
The second project objective is to define the procedure of slide preparation and staining. Several optimisation experiments have been informed in-house and renowned consultant cytopathologists have advised. Such slide preparation has paved the way for developing the automated analysis.
The third objective of the project is to analyse the images of the stained slides which has been done in collaboration with a university. The analysis concerns staining of cells with our patented proliferative biomarker MCM2, and also concerns morphometric features. The first set of results are very encouraging, proving our algorithms to have the potential to be very robust.
Underpinning the objectives of the project is the regulatory path. Before market placement and an extensive programme of clinical evaluation, Cytosystems is aiming for CE-marking and FDA approval.
