Bladder cancer is the fifth most commonly diagnosed cancer in the United States. Three quarters of the nearly 75,000 men and women diagnosed with bladder cancer just this year will have a less aggressive form of the disease which, after treatment, will require frequent visits to the urologist for invasive, painful cystoscopy procedures for the remainder of their lifetimes to determine if the cancer has returned. And the disease will recur in about half of these patients. This is a significant contributing factor to why bladder cancer is considered the most expensive cancer to treat per case and why there exists a compelling need to make the surveillance of bladder cancer recurrence less invasive for patients and more cost-effective for the healthcare system. Unfortunately, the current methods of detecting bladder cancer in urine specimens, an ideal alternative to cystoscopy, are not sufficiently accurate to replace cystoscopy. SynderBio Inc. is developing a device that could be placed at the point of care in the urologist's clinic to rapidly process urine specimens in a way that improves the diagnostic accuracy of routine urine cytology preparations that have been used for decades, but that lack the sensitivity to detect low-grade bladder cancers. SynderBio's first-in-class technology is based on findings that intrinsic biophysical properties can distinguish benign and malignant cells. SynderBio achieves a rapid enrichment of malignant cells by a patented application of brief pulses of very high level fluid shear stress that destroys benign cells, leaving malignant cells that are resistance to this stress and remain intact and viable. SynderBio's approach is innovative because, unlike its use of a unique biophysical biomarker, all of its competitors use specific molecular biomarkers to identify cancer cells in urine specimens. The long-term goal of this project is to improve significantly the detection of bladder cancer recurrence in urine specimens using SynderBio's product. The Phase I hypothesis is that resistance to fluid shear stress is a biomarker that can be used to enrich malignant urothelial cells.
The Aims of the Phase I STTR feasibility project are to: 1) Determine if bladder carcinoma cell lines exhibit greater resistance to FSS in vitro compared to benign urothelial cells; and 2) Determine the feasibility of FSS to improve cytology from bladder cancer patients. Phase II objectives are to 1) transform SynderBio's current pre-prototype device into a commercial-ready product; and 2) expand the clinical testing of this device to determine the extent to which it will improve the accuracy of urine-based testing for bladder cancer. The commercial opportunity for SynderBio's product is significant. Over 2.7 million people worldwide are living with bladder cancer. In the US, bladder cancer surveillance is estimated to be a billion dollar market by 2020. SynderBio's cell separation technology can also be applied to other cancer diagnostic and research purposes, including solid-tissue biopsies. Thus, there is significant commercial potential for SynderBio to build a business to address bladder cancer and other unmet clinical diagnostic needs, thereby improving human health and quality of life.
Bladder cancer is a common, often treatable disease for which most patients must spend their lifetimes after initial diagnosis and treatment regularly returning to the clinic for invasive cystoscopy procedures to determine if the cancer has recurred. There is an unmet medical need to improve significantly the accuracy urine-based diagnosis of bladder cancer to minimize the pain and cost of invasive cystoscopy procedures. SynderBio proposes to demonstrate the feasibility of developing a first-in-class device to use a biophysical biomarker to produce a practical and accurate point-of-care urine-based diagnostic for bladder cancer.
