A Scalable Blood-based Pancreatic Cancer Test for High-Risk Screening

用于高风险筛查的可扩展的基于血液的胰腺癌检测

• 批准号: 9347998
• 负责人: David Freedman
• 金额: $ 22.5万
• 依托单位: NANOVIEW DIAGNOSTICS, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-05-02 至 2019-10-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9347998
• 关键词: Affinity; Age; Biological Assay; Biological Markers; Blinded; Blood; Blood Tests; Blood Volume; Cancer Etiology; Cells; Cessation of life; Clinical; Coupled; Data; Detection; Diagnosis; Diagnostic; Disease; Disease Progression; Early Diagnosis; Excision; Glypican; Goals; Inherited; Institution; Israel; Malignant Neoplasms; Malignant neoplasm of pancreas; Medical center; Methods; Minority; Monitor; Multi-Institutional Clinical Trial; Nature; Neoplasm Circulating Cells; Non-Insulin-Dependent Diabetes Mellitus; Operative Surgical Procedures; Optics; Pancreas; Pancreatic Adenocarcinoma; Pancreatic Diseases; Patients; Performance; Phase; Plasma; Positioning Attribute; Procedures; Process; Production; Protocols documentation; Publications; Quality Control; Reproducibility; Research; Running; Sampling; Screening for cancer; Sensitivity and Specificity; Small Business Innovation Research Grant; Specificity; Survival Rate; Symptoms; System; Techniques; Testing; Time; Translating; Translations; Ultracentrifugation; Ultrasonography; Validation; Variant; Work; base; biobank; cancer cell; cell free DNA; chronic pancreatitis; circulating biomarkers; clinical Diagnosis; clinically translatable; commercialization; cost effective; density; diagnostic assay; early detection biomarkers; exosome; high risk; high risk population; improved; improved outcome; innovation; mortality; nanoparticle; neoplastic cell; novel marker; outcome forecast; particle; research and development; screening; sensor; specific biomarkers; success; therapy development; tool

SUMMARY PI: Freedman, David Scott Institution: nanoView Diagnostics Inc. Pancreatic cancer is the fourth leading cause of cancer death in the US and is estimated to become the second leading cause of cancer deaths in the US by 2020. The high mortality rate is a direct result of early clinical diagnosis being difficult because initial symptoms of the disease are often nonspecific. If pancreatic cancer is detected early, the average five-year relative survival rate increases 11-fold. Tools to detect the disease at the early stage are needed to improve outcomes. There are no clinically validated biomarkers for early detection of pancreatic cancer but studies have shown that exosomes can serve as a perfect blood- based test that and that this biomarker has the potential to be used for pancreatic cancer screening. Despite the identification of this powerful biomarker, tools to translate this test into a scalable workflow are still lacking. nanoView Diagnostics (NVDX) has developed an optical sensing technique that can enumerate these circulating biomarkers directly from sample. The NVDX platform is capable of detecting many different targets from a small volume of blood using a simple workflow and inexpensive consumables. NVDX will establish that a pancreatic test can achieve high sensitivity and specificity in a relatively large number of early-stage pancreatic cancer samples and also demonstrate that the assay is reproducible across a number of sensor manufacturing runs. The second aim test the developed assay with blinded samples to detect early-stage pancreatic cancer and results will be compared to clinical diagnosis. Completion of the phase I work will position NVDX to pursue clinical validation of the exosome based PDAC assay. In a phase II proposal, NVDX will establish standard operating procedures for the assay for user independent performance. The automated NVDX platform will be tested with 300 patients to validate performance and demonstrate clinical utility. The success of the SBIR research would enable nanoView Diagnostics to run multi-center clinical trials for commercialization of a pancreatic screening test.

摘要 派：弗里德曼，大卫·斯科特 机构：NanView诊断公司。 胰腺癌是美国癌症死亡的第四大原因，据估计将成为 到2020年，美国癌症死亡的第二大原因。高死亡率是早期死亡的直接结果 临床诊断很困难，因为该病的初始症状通常是非特异性的。如果是胰腺 癌症发现得早，五年的平均相对存活率提高了11倍。用于检测 需要在早期阶段患病才能改善结果。目前还没有经过临床验证的生物标志物 早期发现胰腺癌，但研究表明，外切体可以作为完美的血液- 该生物标记物具有用于胰腺癌筛查的潜力。尽管 对于这种强大的生物标志物的识别，将这一测试转化为可扩展的工作流程的工具仍然缺乏。 NanView诊断公司(NVDX)已经开发出一种光学传感技术，可以列举这些 直接从样本中循环使用生物标志物。NVDX平台能够探测到许多不同的目标 从少量的血液使用简单的工作流程和廉价的耗材。NVDX将确立 胰腺检测在较大数量的早期胰腺癌中具有较高的敏感性和特异性。 胰腺癌样本，也证明了该分析在许多传感器上是可重复性的 制造业在运转。第二个目的是用盲法检测早期阶段的样品 并将结果与胰腺癌的临床诊断结果进行比较。完成第一阶段的工作将 定位NVDX以寻求基于外切体的PDAC试验的临床验证。在第二阶段提案中，NVDX 将为化验建立标准操作程序，以供用户独立执行。自动化的 NVDX平台将在300名患者中进行测试，以验证性能并展示临床实用性。这个 SBIR研究的成功将使NanView诊断公司能够进行多中心临床试验 胰腺筛查测试的商业化。