Workshop for Continued Harmonization of Beta Cell Death Assays
Contact PI: Carmella Evans-Molina, MD, PhD
Three funded groups within the Human Islet Research Network Consortium on β Cell Death and Survival (CBDS) have developed assays that detect circulating unmethylated preproinsulin (INS) DNA, which is proposed as a marker of dying β cells. The goal of this project is to support a workshop effort to compare these distinct assays. Specifically, samples will be obtained immediately after islet transplantation to provide insight into the comparable sensitivity and specificity of each assay to detect the spike in β cell death that has been demonstrated immediately after islet transplantation. This exercise will also allow for a comparison of the relative specificity and the kinetics of clearance of each specific assay. The successful validation of a robust assay of β cell death has the potential to be paradigm shifting for the field, enabling earlier diagnosis of Type 1 diabetes, better timing of immunomodulatory therapies to prevent loss of β-cell mass and function, as well as improved understanding of clinical trials that test immunomodulatory therapies in established or presymptomatic Type 1 diabetes. Moreover, samples generated as part of this effort will support future workshop efforts to cross-compare other biomarker assays generated in the CBDS.
Opportunity Pool Project Sponsored by CBDS.