Applicable tests in the Market
- Urinary cytology is the most common non-invasive urinary based examination associated, however, with very high inter-observer variability and low sensitivity particularly for low-grade tumours.
- NMP22 (NMP22 Bladder Chek Test). The test could not be effectively marketed by Matritech due to its sub-optimal performance, and is currently distributed by Alere Inc. (Waltham, MA, USA).
- The UroVysion Bladder Cancer Kit (UroVysion Kit) is designed to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus via fluorescence in situ hybridization (FISH) in urine specimens from persons with hematuria suspected of having bladder cancer. The test was FDA approved in 1998. The test kit is marketed by Abbott Molecular Inc., a global company engaged in molecular diagnostics.
Although NMP22 Bladder Chek Test and UroVysion FISH assay received the FDA approval, none of these markers is generally applied, and their value in clinical routine is limited. Therefore, a novel non-invasive urine test for early detection of recurrent BC would be highly innovative.
Treatment and Clinical Trials on Bladder cancer
ClinicalTrials.gov has registered more than 900 clinical trials in the field of BC. Regarding the bladder cancer treatment, novel monoclonal antibody based therapy approaches have been described, e.g. Amgen’s Vectibix® (Plantinumumab), Roche’s Avastin® (Bevacizumab), and kinase inhibitors, e.g. Pfizer’s Receptor-Tyrosinkinase-Inhibitor Sutent® (Sunitinib), Bayer’s Multi-Kinase-Inhibitor Nevaxar® (Sorafenib) or GSK’s TyrosinkinaseInhibitor Tyverb® (Lapatinib). But also innovative immunosuppressors, such as Novartis’ Afinitor® (Everolimus), are applied. These data underline the importance of the drug discovery and development.
Costs for Bladder Cancer patient management
Bladder Cancer has the highest per patient treatment costs, and the 5th highest overall cost. Monitoring generates ~75% of post-diagnosis costs, including post-surgical complications, tri-annual examinations and semi-annual diagnostic and laboratory testing. Progression from NMIBC to MIBC clearly increases overall treatment costs. Early detection of incident and recurrent disease plays a key role in reducing the risk of disease progression. The MIBC patient treatment costs are nearly three times those for patients with stage Tis/Ta.
Within BioMedBC Project, we investigate the application of non-invasive urine based tests to guide therapeutic intervention. Moreover, based on the identified proteomic findings, new drug targets are proposed in order to be further explored as treatment options in future clinical trials.
BioMedBC is a Marie Sklodowska Curie Actions (MSCA) Individual Fellowship programme (H2020-MSCA-IF-2016)
funded by the European Union under the Horizon2020 Framework Programme (Grant Agreement:752755) and
coordinated by Mosaiques diagnostics