Background & Purpose

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PURPOSE

JDRF is soliciting applications for the optimization and/or clinical validation of existing islet autoantibody (AAb) assays. Several newly developed islet AAb assays provide a platform for general population screening for type 1 diabetes (T1D) risk. JDRF intends to support investigators and organizations with assays that have the potential to alter the current islet AAb screening paradigm and have plans to commercialize or distribute their assay for wide-spread adoption and use.

BACKGROUND

The ability to screen for risk and stage of T1D prior to the onset of disease-related symptoms presents a valuable opportunity to delay, and ultimately prevent, stage 3 T1D. Several screening protocols initially focused on screening individuals who have close relatives with T1D, but only about 10% of people who develop T1D fall into this category. JDRF believes that screening all children for islet AAbs, which are prognostic biomarkers for progression to stage 3 T1D, during well-child visits is feasible and should be implemented as part of public health policy. This will not only enable enrollment into T1D prevention trials, but in the short-term, aims to reduce hospitalization and life-threatening diabetic ketoacidosis (DKA) incidents at onset of stage 3 T1D. Current AAb detection assays are not a viable option for T1D risk screening in the general population due to high cost, blood volume requirements and various assay platform considerations. Therefore, new approaches that minimize cost and sample volume requirements are needed to facilitate implementation of general population screening for T1D.

Several new approaches to detect islet AAbs have been developed, which not only increase the sensitivity and specificity of AAb detection, but are poised to support general population screening for T1D risk due to their relatively low cost and minimal blood volume requirement. JDRF has actively supported the development of several of these assays and is dedicated to supporting the continued optimization of such assays.

In order to advance these assays to wide-spread research and ultimately clinical use, validation in real-world clinical research studies is necessary. Therefore, in addition to supporting optimization of the assays, this RFA intends to support clinical research teams already invested in screening populations for T1D AAbs to investigate the utility of the existing assays.