Improved detection of bladder cancer recurrence using a biophysical biomarker

膀胱癌是美国第五种最常见的癌症。近四分之三的人 仅今年就有75,000名被诊断患有膀胱癌的男性和女性将患上侵袭性较低的膀胱癌 这种疾病在治疗后需要经常去看泌尿科医生，进行侵入性的、痛苦的膀胱镜检查 为他们的余生进行手术，以确定癌症是否复发。而这种疾病会 这些患者中约有一半复发。这是为什么膀胱癌被认为是一个重要的因素 每个病例治疗的最昂贵的癌症，以及为什么有迫切的需要进行监测 减少膀胱癌复发对患者的侵袭性更小，对医疗保健系统更具成本效益。 不幸的是，目前在尿样中检测膀胱癌的方法是一种理想的替代 膀胱镜检查的准确性不足以取代膀胱镜检查。SynderBio Inc.正在开发一种设备， 可以放在泌尿科医生诊所的护理点上，以快速处理尿液样本的方式 提高了已经使用了几十年的常规尿液细胞学准备的诊断准确性，但 缺乏检测低级别膀胱癌的敏感性。SynderBio一流的技术基于 发现固有的生物物理特性可以区分良性和恶性细胞。SynderBio实现了 应用获得专利的极高水平流体切应力短脉冲快速浓缩恶性细胞 这会破坏良性细胞，留下对这种压力具有抵抗力的恶性细胞，并保持完好 可行。SynderBio的方法是创新的，因为与其使用独特的生物物理生物标记物不同，它的所有 竞争对手使用特定的分子生物标记物来识别尿样中的癌细胞。长期目标 这一项目的目的是显著提高尿液标本中膀胱癌复发的检测能力 SynderBio的产品。第一阶段假设是对流体剪切力的抵抗力是一种生物标志物，可以 用于浓缩恶性尿路上皮细胞。STTR第一阶段可行性项目的目标是：1)确定 如果膀胱癌细胞株在体外对FSS表现出比良性尿路上皮细胞更大的耐药性；以及 2)探讨FSS改善膀胱癌患者细胞学的可行性。第二阶段的目标是 1)将SynderBio目前的预原型设备转化为商业化产品；2)扩展 对该仪器进行临床测试，以确定它将在多大程度上提高尿液检测的准确性 治疗膀胱癌。SynderBio的产品商机巨大。超过270万人 全世界都患有膀胱癌。在美国，对膀胱癌的监测估计有10亿 到2020年美元市场。SynderBio的细胞分离技术也可以应用于其他癌症诊断 和研究目的，包括固体组织活组织检查。因此，有很大的商业潜力 SynderBio将建立一项业务，以解决膀胱癌和其他未得到满足的临床诊断需求，从而 改善人类健康和生活质量。

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.