Orion is developing a urine based screening test for bladder cancer. The test will diagnose bladder cancer in patients at high-risk (~ 5.1 million people in the US), and will detect recurrent cancer in bladder cancer survivors (~0.5 million in the US).
Orion has patents pending on over 42 novel bladder cancer biomarkers discovered by Orion scientists using our genome-wide biomarker discovery and validation technology, MethylScope. Each biomarker demonstrated greater than 80% sensitivity and 80% specificity, and 7 biomarkers demonstrated 100% sensitivity and 100% specificity in pilot, retrospective, and tissue-based studies, (see Leading Bladder Cancer Screening Biomarkers figure).
In the figure above, the methylation scores of 7 leading bladder cancer biomarkers are plotted for normal lung samples (green circles) and lung tumor samples (red triangles). Each biomarker correctly identified more than 90% of the tumors and normal patient samples evaluated.
|US DX screening population:||5.1 million|
|US recurrence testing population:||0.5 million|
|New cases this year:||67,160|
|Stage||5 Yr Survival||% Cases|
More than 5.1 million (or 15%) men over the age of 50 years old in the US present with symptoms such as blood in their urine or discomfort while urinating. Approximately 10% of these high-risk patients have bladder cancer. We are developing a test to detect bladder cancer in urine of these high-risk patients.
Cancer will recur in 60-80% of the 500,000 bladder cancer survivors in the US. Currently, patients are monitored 2 to 4 times a year, and the combined cost of monitoring and treatment for bladder cancer exceeds $13,000 per patient for a total of $2.9 billion annually. Published studies estimate that the future incorporation of urine based biomarkers into the diagnostic strategy for bladder cancer is estimated to reduce bladder cancer monitoring costs by up to 50%, (J Urol 2003; 169:917-920). We are developing a test to detect cancer recurrence in urine sediments of bladder cancer survivors.