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

总结 PI：Freedman，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，估计将成为美国癌症死亡的第三大原因。 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。 临床诊断困难，因为疾病的初始症状通常是非特异性的。如果胰腺 癌症早期发现，平均五年相对存活率增加11倍。工具来检测 疾病的早期阶段，以改善结果。没有临床验证的生物标志物 胰腺癌的早期检测，但研究表明，外泌体可以作为一个完美的血液， 该生物标志物有可能用于胰腺癌筛查。尽管 这种强大的生物标志物的鉴定，将这种测试转化为可扩展的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 直接从样本中提取循环生物标志物。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获得。NVDX将确定， 胰腺试验可以在相对大量的早期胰腺癌中实现高灵敏度和特异性， 胰腺癌样本，也证明了该测定在许多传感器上是可重复的 生产运行。第二个目的是用盲法样本测试开发的检测方法，以检测早期 胰腺癌和结果将与临床诊断进行比较。第一阶段工作完成后， 定位NVDX以追求基于外泌体的PDAC测定的临床验证。在第二阶段的提案中，NVDX 将为用户独立性能的测定建立标准操作规程。自动 NVDX平台将在300名患者中进行测试，以验证性能并证明临床实用性。的 SBIR研究的成功将使nanoView Diagnostics能够进行多中心临床试验， 胰腺筛查试验的商业化。

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.