NANOCYTOMICS LLC — Department of Health and Human Services SBIR Phase I: NCI

Description

DESCRIPTIONprovided by applicantThe goal of this SBIR project is to develop a minimally intrusivehighly sensitive risk stratification tool to determine the need for invasive pancreatic cancerPCscreeningPC is theth leading cause of cancer deaths in the USWhile early stage disease is generally curablethe vast majority of patients are diagnosed in advancedunresectable stages due in large part to the lack of a suitable candidate screening technologyUnfortunatelyall current screening modalitiesERCP or EUSsuffer from a very high false positive ratehigh costinvasivenessand risk of serious complicationsThis underlines the urgent need for developing an effective test that targets PCat an early stageThe present project is based on a novel biophotonics technology that is exclusively licensed to NanoCytomics by Northwestern UnivPartial Wave SpectroscopicPWSmicroscopyandapos nanocytologyandaposthat has been shown to sense and quantify nanoscale early stage tumorigenic alterations within histologically normalappearing cellsPWS uses the phenomenon of field carcinogenesisthe concept that the genetic epigenetic alterations that lead to PC are also reflected in endoscopically normal periampullary duodenal mucosa either through shared risk factors or secreted factorscytokines etcfrom the pancreatic juiceAlthough the duodenal cells in PC patients appear endoscopically and microscopically normalthere are profound epigenetic alterationse gmethylationmicroRNA etcwhose nanoscale corollarye ghigh order chromatinare detectable by partial PWSThe detection of nanoscale structural alterations of the fertile tumorigenic field may allow to risk stratify patients with early stage cancers or precancerous lesions located anywhere in duodenumThusour preliminary data showed that the PWS detectable nano morphological alterations of periampullary duodenal cells are a highly sensitive and specific biomarker for PCTo perform the academic to commercial transition and establish duodenal nanocytology as a commercially viableminimally intrusiveand highly sensitive pre screen for PCseveral steps must be completedIn the present Phase I SBIR projectstandard operating proceduresSOPthat are optimized for stabilityreliability and diagnostic potential will be developed and validatedThe future steps of this project will include refinement and optimization of the PWS markers in Phase IIthus enhancing its diagnostic powerfollowed by a multi center clinical trial critical for the eventual regulatory approvalWe envision that PWS analysis of cells brushed from the periampullary duodenal mucosa of high risk patientsnew onset diabeticsfamily historychronic pancreatitisetcas well as those undergoing EGD for other indications will serve as a gauge of risk probability and can be used to risk stratify and hence tailor screening surveillance decisions thus identifying the subset of patients who may benefit from further screeningsuch as a pancreatic CT MRI or EUS ERCPIn the long termduodenal PWS can be combined with the existing upper GI screening by ultrathin EGDthus allowing for a pan upper GI cancer screening PUBLIC HEALTH RELEVANCEPancreatic cancer is theth leading cause of cancer deaths in the US with no effective screening procedures availableThis SBIR project proposes a minimally intrusive and highly sensitive screening tool for patients who are at a higher risk for pancreatic cancerThis involves sampling of the duodenal mucosa during ultrathin esophago gastroduodenoscopythus avoiding the complications and costs of the currently used techniques