Rapid Test for Pancreatic Cancer: Biomarker Selection, Assay Development and Clinical Validation

Pancreatic cancer represents an unmet medical need for many reasons. The prognosis is still extremely poor and this can largely be attributed to the lack of methods for early detection.

At the time of diagnosis, most patient with pancreatic cancer have advanced-stage disease for which treatment options are limited.

Our goal is to develop a method that can detect pancreatic cancer in localized stages when curative treatment is still possible. In the first phase of the project, we evaluated 20 different biomarkers in clinical samples (n=300). The data obtained from this evaluation was used to select 5 biomarkers and define a diagnostic algorithm.

A proof-of-concept assay was successfully developed for the 5 selected biomarkers using ultra-sensitive, multiplex, lateral flow technology (Patent Filed).

The next step is to optimize the lateral flow platform and evaluate the analytical and clinical performance of the test on blood samples across multiple different settings and different demographics.

The final test is intended for high-risk patients, including those with hereditary/familial pancreatic cancer or new onset diabetes mellitus >50-years, as well as for patients with diffuse abdominal symptoms, to rule out pancreatic cancer.