Our Initiatives
Advancing Platforms for HIV Viral Load Testing and Monitoring
About
Cimit helps to manage and accelerate the regulatory clearance and commercialization of innovative HIV viral load testing and monitoring platforms. Thus far, two solicitations have been issued and several projects have been selected to move forward and are progressing toward regulatory approval and, ultimately, commercialization.
Overview
To rapidly advance the development and regulatory approval of innovative point-of-care HIV viral load testing and monitoring platforms that:
- facilitates monitoring of antiretroviral therapy (ART) effectiveness.
- accurately assesses potential for transmission.
At the end of 2021, approximately 1.2 million adults and adolescents in the US were living with HIV, and about 13 percent were unaware of their HIV status. Ninety-two percent of new transmissions resulted from people who were unaware of their status.
Significant work will be required to meet UNAIDS 2025 AIDS targets, including increased testing and status awareness, improved viral monitoring technologies, and better access to holistic treatment.
Viral monitoring is critical to improved treatment and outcomes. The National Institutes of Health (NIH)-funded clinical trials have demonstrated that ART enhances quality of life, and durable viral suppression virtually eliminates the chance of sexual transmission of the virus (a concept known as Undetectable = Untransmittable).
Low-cost, accessible viral load monitoring is an important tool to prevent transmission of HIV.
Core Leads
Michael Dempsey
Subprojects Core Lead for CINTA; Entrepreneur-in-Residence, Consultant Innovator, Cimit
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Penny Ford-Carleton, RN, MS, MPA, MSC
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CINTA Staff
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
John Collins, PhD
Director Innovation Platforms, Cimit and CINTA
Challenge
In late spring 2024, the National Institute of Biomedical Imaging and Bioengineering (NIBIB) in conjunction with the NIH Office of AIDS Research and the National Institute of Allergy and Infectious Diseases, announced a RADx® Tech program soliciting proposals to rapidly drive forward commercialization of point-of-care HIV viral load detection technologies to meet unmet national and international needs.
In particular, NIBIB sought proposals for technologies with a level of analytical performance, especially for viral load limit of detection, that facilitated monitoring ART effectiveness (i.e. viral rebound) and accurately assessed the potential for transmission.
This program is based upon the success of the 2022 NIBIB Independent Test Assessment Program (ITAP) that solicited proposals to accelerate the validation and prototyping of innovative HIV viral load testing platforms.
Cimit helped to:
- design both programs
- manage outreach and solicit proposals
- engage experts to review applications, work with teams, and propose the strongest projects to NIBIB and its partners
For award recipients, Cimit oversaw the innovation process, facilitated teams through a milestone-driven approach to development, and provided teams with mentors on product development and business and regulatory processes, as well as other resources.
Impact
In December 2024, three diagnostic technology developers were selected to advance based on evaluation against project criteria and were ultimately awarded more than $4 million in funds and support services.
Activities
Projects are ongoing.