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.

概括 PI：弗里德曼，大卫·斯科特 机构：nanoView Diagnostics Inc. 胰腺癌是美国癌症死亡的第四大原因，预计将成为美国癌症死亡的第四大原因。 到 2020 年，癌症将成为美国第二大癌症死亡原因。高死亡率是早期癌症的直接结果 临床诊断很困难，因为该疾病的初始症状往往是非特异性的。如果是胰脏 癌症若能及早发现，平均五年相对生存率可增加 11 倍。检测工具 需要在疾病的早期阶段进行治疗才能改善结果。目前尚无经过临床验证的生物标志物 胰腺癌的早期检测，但研究表明外泌体可以作为完美的血液 基于测试，该生物标志物有潜力用于胰腺癌筛查。尽管 这种强大的生物标志物的识别，以及将该测试转化为可扩展工作流程的工具仍然缺乏。 nanoView Diagnostics (NVDX) 开发了一种光学传感技术，可以枚举这些 直接从样本中循环生物标志物。 NVDX平台能够检测许多不同的目标 使用简单的工作流程和廉价的耗材从少量血液中提取。 NVDX 将确定 胰腺测试可以在相对大量的早期阶段获得较高的敏感性和特异性 胰腺癌样品，还证明该测定在许多传感器上是可重复的 制造运行。第二个目标是用盲样测试开发的检测方法以检测早期阶段 胰腺癌及其结果将与临床诊断进行比较。第一阶段工作的完成将 NVDX 致力于对基于外泌体的 PDAC 检测进行临床验证。在第二阶段提案中，NVDX 将建立独立于用户性能的检测标准操作程序。自动化的 NVDX 平台将在 300 名患者身上进行测试，以验证性能并展示临床实用性。这 SBIR 研究的成功将使 nanoView Diagnostics 能够针对以下疾病开展多中心临床试验： 胰腺筛查测试的商业化。