# Point of Care Technology Research Center in Primary Care - ITAP

> **NIH NIH U54** · MASSACHUSETTS GENERAL HOSPITAL · 2022 · $204,471

## Abstract

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.

## Key facts

- **NIH application ID:** 10520518
- **Project number:** 3U54EB015408-09S4
- **Recipient organization:** MASSACHUSETTS GENERAL HOSPITAL
- **Principal Investigator:** John A Parrish
- **Activity code:** U54 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $204,471
- **Award type:** 3
- **Project period:** 2022-04-01 → 2023-09-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10520518

## Citation

> US National Institutes of Health, RePORTER application 10520518, Point of Care Technology Research Center in Primary Care - ITAP (3U54EB015408-09S4). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10520518. Licensed CC0.

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