Point of Care Technology Research Center in Primary Care - ITAP

Project Summary/Abstract The goal of the NIH Independent Test Assessment Program (ITAP) is to create an accelerated pathway to provide FDA evaluation of tests to assist with large-scale manufacturing. Working closely with the NIH and FDA, CIMIT will provide dedicated ITAP resources and manage the processes for independent laboratory validation, clinical studies, and streamlined

data collection in support of FDA emergency use authorization (EUA) applications. CIMIT will create a process workflow and establish a streamlined process to manage the documentation and tracking of ITAP projects. Applicants to ITAP will be evaluated for participation based on several criteria surrounding EUA for point-of-care (CLIA-Waived), high

volume test kit manufacturing capacity, and a demonstrated capability for reproducibly manufacturing and distributing high quality products. Applicants accepted into the program will move through the developed ITAP workflow, including a “DASH,” and the potential for Phase 2 Testing, OTC Clinical Study or Fast Track Clinical Study.

CIMIT will leverage existing relationships between RADx and regulatory authorities to make regulatory input available for project teams and ensure that teams utilize well-established quality systems methods in the course of their work, in order to accelerate the availability of more high- quality and reliable OTC tests to the public as quickly as possible.