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

SUMMARY PIFreedmanDavid Scott InstitutionnanoView Diagnostics IncPancreatic 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 byThe high mortality rate is a direct result of early clinical diagnosis being difficult because initial symptoms of the disease are often nonspecificIf pancreatic cancer is detected earlythe average five year relative survival rate increasesfoldTools to detect the disease at the early stage are needed to improve outcomesThere are no clinically validated biomarkers for early detection of pancreatic cancer but studies have shown that exosomes can serve as a perfect bloodbased test that and that this biomarker has the potential to be used for pancreatic cancer screeningDespite the identification of this powerful biomarkertools to translate this test into a scalable workflow are still lackingnanoView DiagnosticsNVDXhas developed an optical sensing technique that can enumerate these circulating biomarkers directly from sampleThe NVDX platform is capable of detecting many different targets from a small volume of blood using a simple workflow and inexpensive consumablesNVDX 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 runsThe second aim test the developed assay with blinded samples to detect early stage pancreatic cancer and results will be compared to clinical diagnosisCompletion of the phase I work will position NVDX to pursue clinical validation of the exosome based PDAC assayIn a phase II proposalNVDX will establish standard operating procedures for the assay for user independent performanceThe automated NVDX platform will be tested withpatients to validate performance and demonstrate clinical utilityThe success of the SBIR research would enable nanoView Diagnostics to run multi center clinical trials for commercialization of a pancreatic screening test