Here’s a concise summary of the RADx® Tech Independent Test Assessment Program (ITAP) for Hepatitis C Virus (HCV) RNA Near-Patient Diagnostics (2026):
Executive Summary
The NIH/NIBIB RADx® Tech Independent Test Assessment Program (ITAP) is seeking to accelerate the development, regulatory authorization, and commercialization of near-patient (point-of-care) HCV RNA diagnostic tests. The program is managed by CIMIT in partnership with NIH and FDA and is modeled after the highly successful COVID-19 RADx program that rapidly brought dozens of diagnostic tests to market.
Program Objectives
The program is designed to help manufacturers:
- Validate the analytical and clinical performance of HCV RNA tests.
- Generate the evidence needed for FDA regulatory submission.
- Speed commercialization of high-quality point-of-care molecular diagnostics.
- Reduce the time between HCV diagnosis and treatment initiation through rapid, decentralized testing.
What Technologies Are Eligible?
The opportunity is aimed at companies developing near-patient HCV RNA tests that are:
- Near or at design lock (not early-stage research).
- Capable of entering manufacturing relatively quickly.
- Intended for use outside of traditional central laboratories.
- Able to meet FDA performance and quality requirements.
What Support Does ITAP Provide?
Unlike a traditional research grant, ITAP provides an intensive commercialization support program that may include:
- Independent analytical and clinical testing
- Regulatory strategy and FDA interaction
- Study design and execution
- Quality systems guidance
- Manufacturing and commercialization planning
- Access to clinical and technical experts throughout development
The goal is to reduce both technical and regulatory risk while accelerating FDA clearance or authorization.
Why This Matters
Traditional HCV diagnosis often requires:
- Antibody screening
- Referral for laboratory RNA confirmation
- A second patient visit before treatment
Many patients are lost during this process.
Rapid point-of-care HCV RNA testing enables diagnosis in approximately one visit, making same-day or rapid treatment initiation feasible. This is considered a key strategy for achieving U.S. and global HCV elimination goals.
Why NIH Is Investing
The program builds on the success of RADx COVID-19, which:
- Reduced review times from months to about 35 days.
- Helped bring dozens of diagnostic tests to market.
- Created an innovation process that combines technical, clinical, commercial, and regulatory expertise to rapidly mature promising technologies.
Potential Relevance for LiverRight
This initiative aligns closely with LiverRight’s mission of identifying and treating patients with liver disease at scale. Point-of-care HCV RNA diagnostics could:
- Support “test-and-treat” workflows in primary care, FQHCs, addiction medicine, and emergency departments.
- Shorten the time from screening to antiviral treatment.
- Reduce patient loss to follow-up.
- Integrate well with LiverRight’s Find42™ population identification platform by enabling immediate confirmatory testing after identifying high-risk individuals.
For organizations focused on HCV elimination, these technologies could significantly improve linkage-to-care rates and increase treatment completion.
