Urine test for bladder cancer detection and monitoring
Bladder cancer has the highest lifetime per-patient cost of any cancer type due to its high recurrence rate. Cystoscopy, the gold standard for detection and monitoring, is an invasive, uncomfortable, and costly procedure. This accurate urine-based test has the potential to reduce the need for cystoscopies by more than 50%, offering a more comfortable and cost-effective solution for both patients and healthcare systems.
Business Opportunity
Our urine-based test offers a non-invasive, accurate, and cost-effective alternative to cystoscopy for detecting and monitoring bladder cancer. It addresses a significant unmet need in a large and growing market, with potential to reduce procedures, lower costs, and improve patient experience. Developed by a team of scientists at Oslo University Hospital, the test represents a significant advancement in bladder cancer care. Inven2 AS seeks partners for co-development and/or licensing of the technology.
Technology Description
Based on a robust discovery and validation workflow, the researchers have identified eight methylome biomarkers with an optimized Digital droplet PCR analysis platform for urine-based detection of bladder cancer.
High performance validated by robust clinical studies:
- Detection: Analyzed in a prospective series of 273 hematuria patients; sensitivity of 92% (85% for Ta tumors), specificities of 92% and a NPV of 98%.
- Monitoring of recurrence: Analyzed in a prospective study with 47 NMIBC patients followed for 2 + 1 years: sensitivity of 91% (83% for Ta and 100% for CIS, T1 and T2) and NPV of 99%.
Key benefits
- Highly competitive: Accurate detection across tumor grades and stages compared to existing tests
- Non-Invasive: Urine-based test offering a comfortable, and cost-saving alternative to cystoscopy
- Robust clinical study design: Ensuring reliable development and validation
- Actionable Outcomes: Fills critical gaps in care standards, enabling informed decision-making
Intellectual Property
The product integrates methylated markers from two biomarker panels, with the first panel covered by granted US and EP patents while the second is pending US and EP application approval. US patent applications are also pending for optimized digital droplet PCR controls.