Advanced Platforms for HIV Viral Load Monitoring - CIMIT MAIN

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null Advanced Platforms for HIV Viral Load Monitoring

Advanced Platforms for HIV Viral Load Monitoring at the Point-of-Care

Overview

According to the FY 2021-2025 NIH Strategic Plan for HIV and HIV-Related Research coordinated by the NIH Office of AIDS Research (OAR) HIV persists as one of the world’s most serious public health, development, and economic challenges. As new acquisitions continue to affect communities and augment disparities, HIV remains a major global public health issue that requires immediate attention. In 2022, an estimated 39 million people worldwide were living with HIV, an increase of more than 14 percent from 33.4 million people in 2010.

Further, at the end of 2021, approximately 1.2 million adults and adolescents were living with HIV in the United States. About 13 percent of these were unaware of their HIV status. Of those who were aware of their HIV status, 75 percent were engaged in care, 54 percent of those were retained in care, and only 66 percent of those in care achieved viral suppression. Importantly, 92% of the new transmissions resulted from people who were unaware of their status. Significant work lies ahead to achieve UNAIDS 2025 AIDS targets that aim for 95% of people with HIV to know their status, 95% of people who know their status to initiate antiretroviral therapy (ART), and 95% of those on treatment to have viral suppression (95-95-95). Keys steps to be taken to achieve this goal include increased testing and status awareness, improved access to treatment, strengthened laboratory infrastructures and development of improved viral load (VL) monitoring technologies, and a holistic approach to care.

Overwhelming evidence from NIH-funded clinical trials in multiple settings demonstrates that ART enhances health and quality of life, and that durable viral suppression virtually eliminates the chance of sexual transmission of HIV – a concept known as Undetectable = Untransmittable (U=U), or Treatment as Prevention (TasP). U=U is an essential component for ending the epidemic. When people learn that U=U, they are more likely to get tested and to start and stay on a treatment. Affordable and accessible HIV VL monitoring is a critical tool to prevent HIV transmission and empower people with HIV to take charge of their own health care.

As reviewed by McFall et al. (Current Opinion in Biomedical Engineering 2019, 11:9–15), HIV VL monitoring is generally performed at treatment initiation, then again after three to six months of ART, and at least once annually when VL is undetectable. Clinicians often check after one month of treatment to evaluate for alpha decay of the virus on therapy and to assess early adherence.

Since monitoring VL detects viral rebound and any detectable VL may indicate potential for HIV transmission, VL monitoring plays an important role in monitoring ongoing effectiveness of therapy and assessing the potential for transmission. However, there is a significant unmet need across the United States to provide VL testing at the point-of-care with a platform that is sufficiently sensitive and simple to use so that people with HIV can readily assess ART effectiveness and potential for transmission in their communities.

Therefore, in collaboration with the NIH OAR and National Institute of Allergy and Infectious Diseases (NIAID), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) announces that its Rapid Acceleration of Diagnostics (RADx®) program is soliciting proposals to further advance HIV viral load detection technologies to fill specific unmet national and global needs. Under this solicitation, NIBIB is seeking proposals to accelerate the regulatory clearance and commercialization of innovative HIV VL testing platforms that are designed for use at the point-of-care that fill unmet national and global needs with a level of analytical performance, especially for VL limit of detection, that facilitates monitoring ART effectiveness (i.e., viral rebound) and accurately assessing potential for transmission.

NIH has assembled a national network of expert technical, clinical, manufacturing, and regulatory advisors who will provide individualized assistance for projects. NIBIB plans to support analytical and clinical testing to accelerate test validation and regulatory review of POC tests. These efforts will facilitate rapid production and commercialization of POC HIV VL tests in the U.S.

Submissions will follow a staged review process

Project proposals will be accepted and reviewed online via Cimit's CoLab platform. Innovators can access the online portal here.

To register, Applicants must establish an account in the portal. Once registered, Applicants will be asked to provide a submission Title and Executive Summary, the latter of which should include a brief description of the technology and how it will improve viral load testing at the point-of-care for people with HIV. Do not include any proprietary or confidential information in the Title and Executive Summary sections as they may be publicly shared if selected. Applicants will then need to respond to a series of specific prompts across different evaluation criteria that will include details of technical capability and readiness, clinical impact, commercialization pathway, and regulatory feasibility. In brief, Applicants will be asked to provide:

Applications must respond to all the following:

  • Detail the limitations of the currently available solutions and describe how the proposed approach will advance upon current technology.
  • Clearly define the current state of the art and highlight how the proposed technology will advance clinical care and be adapted to the workflow at the point-of-care.
  • Include data showing the proposed solution is at/near design lock.
  • Detail the advantages of the proposed solution, i.e., how the assay will be able to detect any major circulating HIV types in the target population with high specificity. For monitoring viral suppression, the assay should appropriately consider the need to prevent the detection of cell-associated HIV DNA and RNA.
  • Demonstrate consideration for the cost of goods for the platform and suggest whether it appears feasible that the diagnostic test could be implemented at the point-of-care.
  • Demonstrate capacity for manufacturing and distributing high-quality in vitro diagnostic tests
  • Describe sample prep and processing from whole blood or plasma and how the technology can achieve detection limits under 1000 copies/ml.
  • Provide an estimated budget and proposed high-level milestones for the project.

Responsive applications may also pivot and refine existing technologies toward new intended use at the point-of-care. Applicants with technology that could eventually be adapted for multiplex detection of common cooccurring infections (e.g., Mycobacterium tuberculosis [TB], hepatitis B and C viruses [HBV, HCV], human papillomavirus [HPV] and other sexually transmitted infections [STIs]) and in-home use are strongly encouraged to apply.

Applicants are encouraged to use people first language consistent with the NIAID HIV Language Guide. This guide includes person-centered language suggestions for communicating about HIV and related topics. The guide was designed to help those working in HIV-related research to communicate about their work using empowering rather than stigmatizing language, especially as it relates to HIV.

Applications will not be considered for:

  • Device technologies that do not significantly advance upon the state of the art.
  • Animal model development: all in vivo models must be well established and characterized, and available to the applicant.
  • Efforts to develop technology for fundamental study of HIV.
  • Fundamental/basic research projects.
  • Device technologies not regulated by the FDA.

Review Process

Proposals will be reviewed by an external panel of experts for technical, clinical, commercialization and regulatory feasibility based on the Project Review Criteria stated below. NIH will make the final determination about which proposals will advance based on stated criteria and potential for commercialization

Project Review Criteria

Each application will be reviewed by an independent external expert panel to assess the potential of the proposed solution to meet each of the following criteria.

  • The technology fulfills an unmet national and global testing need (as described above), including how the approach improves upon the state of the art.
  • The technology is at or near design lock and can be independently validated during the performance period.
  • The technology uses sample volumes compatible with POC collection and can achieve a limit of detection of 1,000 copies/mL or better.
  • Ability of the solution to serve/deploy to underserved, hardly-reached communities is highly desirable.
  • Demonstrated capacity for manufacturing and distributing high-quality in vitro diagnostic tests under an established Quality Management System.
    • Viable plans are provided for eventual production including forecasts, timeline,
      milestones, supply chain needs, product cost, and other ramp-up considerations.
    • Critical commercial partners, contractors, vendors, and service providers have
      been identified or secured.
  • Applicants must have a permanent U.S. address.
  • The projected cost for the platform will not be a barrier to its implementation at the point-of-care.
  • Price of the proposed product is competitive with alternatives and aligned with reimbursement.
  • Appropriateness of the platform to be employed at the point-of-care setting and potentially CLIA-waived.

Timeline and Award Information

Applications must be submitted by June 14, 2024, 11:59pm ET. It is anticipated that proposal review will occur in June 2024 with one or more awards being made shortly thereafter. Up to 4 organizations will be selected to advance based upon the Project Review Criteria. Each of the advancing organizations will receive a milestone-based fixed-price award of up to $1,000,000 total cost. Final budgets and detailed milestones to be negotiated at time of award.

FAQs about this program can be found here.

For other programmatic or technical questions please contact cimitcommunications@partners.org.

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About Point-of-Care Technology Research Center (POCTRN)

The goal of POCTRN is to develop technologies with clinical applications using a network model that enhances complementary strengths and builds multidisciplinary partnerships. NIBIB created POCTRN in 2007 to facilitate the development of a pipeline of point-of-care technologies with commercialization potential, to utilize a center structure that enables the incorporation of clinical and user needs in the development process, and to provide expertise and resources to address early barriers to commercialization and implementation.

About National Institute of Biomedical Imaging and Bioengineering (NIBIB)

The mission of NIBIB is to improve health by leading the development and accelerating the application of biomedical technologies. The Institute is committed to integrating the physical and engineering sciences with the life sciences to advance basic research and medical care.

About Office of AIDS Research (OAR)

OAR is part of the Office of the Director, NIH, and works in partnership with the NIH Institutes, Centers, and Offices to coordination of the NIH HIV Research Program to ensure that HIV/AIDS research is aligned with the NIH Strategic Plan for HIV and HIV Related Research. OAR does not award grants but co-funds HIV-related applications and research projects that have received an award from NIH Institutes and Centers (ICs). Projects must align with at least one of the strategic goals and objectives outlined in the NIH Strategic Plan for HIV and HIV Related Research. The NIH provides the largest public investment in HIV/AIDS research globally. As HIV crosses nearly every area of medicine and scientific investigation, the response to the HIV pandemic requires a multi-Institute, multidisciplinary, global research program. OAR provides scientific coordination and management of this research program. The vision of the NIH OAR is to advance research to end the HIV pandemic and improve health outcomes for people with HIV.

About National Institute of Allergy and Infectious Diseases (NIAID)

NIAID conducts and supports basic and applied research to better understand, treat, and ultimately prevent infectious, immunologic, and allergic diseases. For more than 60 years, NIAID research has led to new therapies, vaccines, diagnostic tests, and other technologies that have improved the health of millions of people in the United States and around the world.

About Cimit

Cimit’s mission is to drive the future of health innovation. We work alongside groups dedicated to advancing groundbreaking solutions by delivering the expertise needed every step of the way.