Improved detection of bladder cancer recurrence using a biophysical biomarker

使用生物物理生物标志物改进膀胱癌复发的检测

• 批准号: 9988591
• 负责人: Michael D Henry
• 金额: $ 0.2万
• 依托单位: SYNDERBIO, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-18 至 2020-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9988591
• 关键词: Address; Aftercare; Benign; Biological Markers; Biological Sciences; Biophysics; Biopsy; Bladder; Businesses; Cancer Diagnostics; Cancer Patient; Cancer cell line; Cell Line; Cell Separation; Cells; Characteristics; Clinic; Clinical Research; Cystoscopy; Cytology; Cytopathology; Data; Detection; Devices; Diagnosis; Diagnostic; Diagnostic Procedure; Diagnostics Research; Disease; Elements; Environment; Exhibits; FDA approved; Future; Goals; Gold; Growth; Health; Healthcare; Healthcare Systems; Human; In Vitro; Interobserver Variability; Iowa; Label; Legal patent; Life; Liquid substance; Location; Malignant - descriptor; Malignant Neoplasms; Malignant neoplasm of urinary bladder; Marketing; Medical; Methods; Monitor; Morphologic artifacts; Newly Diagnosed; Outcome; Pain; Patient Triage; Patients; Performance; Phase; Physiologic pulse; Preparation; Procedures; Process; Quality of life; Recurrence; Research; Resistance; Sales; Sampling; Side; Site; Small Business Technology Transfer Research; Solid; Specificity; Specimen; Statistical Study; Stress; Technology; Testing; Tissues; United States; Universities; Urine; Urologist; Urology; Urothelial Cell; Visit; Woman; Work; base; biophysical properties; bladder Carcinoma; cancer cell; cancer diagnosis; cancer recurrence; cancer type; clinical diagnostics; clinical practice; commercial application; commercialization; cost; cost effective; design; diagnostic accuracy; improved; innovation; innovative technologies; instrument; instrumentation; men; molecular marker; non-muscle invasive bladder cancer; novel; off-patent; phase 2 study; point of care; preservation; prototype; research clinical testing; response; sample fixation; shear stress; urinary

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.

膀胱癌是美国第五大最常见的癌症。近四分之三的 仅今年就有75，000名男性和女性被诊断患有膀胱癌， 治疗后需要经常到泌尿科医生处进行侵入性、疼痛性膀胱镜检查的疾病 在他们的余生中进行手术，以确定癌症是否已经复发。疾病会 这些患者中约有一半复发。这是一个重要的促成因素，为什么膀胱癌被认为是 每例治疗最昂贵的癌症，以及为什么迫切需要进行监测 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，目前的方法检测膀胱癌的尿液标本，一个理想的替代， 膀胱镜检查不足以准确地取代膀胱镜检查。SynderBio公司正在开发一种设备， 可以放置在泌尿科医生诊所的护理点，以快速处理尿液样本， 提高了已经使用了几十年的常规尿细胞学准备的诊断准确性，但是 缺乏检测低度膀胱癌的灵敏度。SynderBio的一流技术基于 研究发现，内在的生物物理特性可以区分良性和恶性细胞。SynderBio实现了 通过专利的极高水平流体剪切应力的短暂脉冲应用快速富集恶性细胞 破坏良性细胞，留下恶性细胞抵抗这种压力并保持完整， 可行的SynderBio的方法是创新的，因为与其使用独特的生物物理生物标志物不同， 竞争对手使用特定的分子生物标志物来识别尿液样本中的癌细胞。远景目标 该项目的主要目的是利用尿液样本显著提高膀胱癌复发的检测， SynderBio的产品第一阶段的假设是，对流体剪切应力的抵抗是一种生物标志物， 用于富集恶性尿路上皮细胞。第一阶段STTR可行性项目的目标是：1）确定 与良性尿路上皮细胞相比，膀胱癌细胞系是否在体外表现出对FSS更大的抗性;以及 2)确定FSS改善膀胱癌患者细胞学检查的可行性。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 对该器械进行临床试验，以确定其将在多大程度上提高尿液检测的准确性 治疗膀胱癌SynderBio产品的商业机会非常重要。超过270万人 全世界都患有膀胱癌。在美国，膀胱癌监测估计为10亿 2020年的美元市场。SynderBio的细胞分离技术也可应用于其他癌症诊断 和研究目的，包括固体组织活检。因此，具有巨大的商业潜力， SynderBio将建立一个业务，以解决膀胱癌和其他未满足的临床诊断需求，从而 改善人类健康和生活质量。