VentureWell manages a network of expert consultants and vendors within many RADx® programs, including COVID-19 and RADx® Tech innovation funnel–style projects for other health challenges. Read more about the our current portfolio of work, including the COVID-19 Program and other RADx® Tech–type programs:
COVID-19
The goal of the RADx® Innovation Funnel for COVID-19 is to accelerate the development of next-generation COVID-19 diagnostic technologies with a focus on performance and accessibility innovations. People with disabilities such as visual or motor impairments may struggle to independently use any of the widely available at-home tests. To inform the modification or development of more accessible tests, RADx® Tech companies are working with manufacturers to address device design, packaging, and modes of instruction, among other challenges. They are also rapidly iterating these tests to align with current public needs and challenges, such as combining COVID-19 and Flu A/B. The program provides support for expedited authorization for emergency use, 510(k) approval, and future development of point-of-care and at-home diagnostics.
Visit the POCTRN RADx® Tech III sites and read about outcomes of the program at RADx® Tech: Delivering COVID-19 Diagnostic Technologies at Unprecedented Speed and Scale.
Maternal Health
The National Institutes of Health (NIH) offered up to $8 million in cash prizes to accelerate development of technologies to improve maternal health outcomes for those who live in areas lacking access to maternity care. The Rapid Acceleration of Diagnostics Technology (RADx® Tech) for Maternal Health Challenge prioritized home-based or point-of-care diagnostic devices, wearables, and other remote sensing technologies to improve postpartum healthcare in these regions. The Eunice Kennedy Shriver National Institute of Child Health and Development (NICHD), the National Institute of Biomedical Imaging and Bioengineering (NIBIB), and the NIH Office of the Director co-sponsored this challenge as part of NIH’s Implementing a Maternal health and Pregnancy Outcomes Vision for Everyone (IMPROVE) Initiative. VentureWell provided programmatic support to help expedite funding and support for teams in this challenge-focused program.
HIV
The NIH Strategic Plan for HIV and HIV-Related Research (FY 2021-2025) organized by the NIH Office of AIDS Research (OAR) serves as a framework to support research for technologies aimed at preventing, treating, and curing HIV and AIDS. This initiative has led to the launch of numerous programs targeting the advancement of technologies in the HIV space.
Viral Load Detection
The National Institute of Biomedical Imaging and Bioengineering (NIBIB), through the Point-of-Care Technology Research Network (POCTRN), solicited proposals to further advance HIV viral load (VL) detection technologies in order to fill specific unmet national and global needs. Under this solicitation, NIBIB sought proposals to accelerate the validation and prototyping of innovative HIV VL testing platforms. These technologies were designed for use at the point of care and fill unmet national and global needs with a level of analytical performance. The program was funded and a company has been supported in the commercialization of their technology.
Diagnostics
The success of the HIV Viral load detection program led to a new innovation program focused on HIV diagnostics. The National Institute of Biomedical Imaging and Bioengineering (NIBIB) is seeking to accelerate the development of point-of-care and home-based HIV diagnostic technologies. This strategy also supports goals from the FY 2021–2025 NIH Strategic Plan for HIV and HIV-Related Research (coordinated by OAR), including to “advance rigorous and innovative research to end the HIV pandemic and improve the health of people with, at risk for, or affected by HIV across the lifespan, and to ensure that the NIH HIV research portfolio remains flexible and responsive to emerging scientific opportunities and discoveries”. The program will provide support to bring technologies in the HIV diagnostic space to a commercial readiness stage for undergoing regulatory review and approval.
Mpox
In July of 2022, the World Health Organization (WHO) declared the Mpox Public Health Emergency of International Concern (PHEIC). The public health crisis further emphasized the need for advancement of technology in the Mpox space. This ultimately led to the launch of several funded programs to support the development of direct diagnostics technology of MPox and similar diseases. Two of these programs that VentureWell has been involved in to date are discussed below.
Diagnostics
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) mobilized and expanded the focus of the RADx®-like Independent Test Assessment Program (ITAP) to increase availability of high-quality, accurate, and reliable Mpox virus diagnostic tests. NIBIB provided in-kind analytical and clinical testing required by the U.S. Food and Drug Administration (FDA) to accelerate test validation and regulatory review of molecular and antigen-based point-of-care (POC) or home diagnostic tests and home collection tests. These efforts facilitated rapid production and commercialization of Mpox Virus assessment healthcare tools in the United States.
Lesion Panel
The goal of the RADx® ITAP for Mpox lesion panel is to accelerate regulatory review and availability of high-quality, accurate, and reliable diagnostic tests to the public. Specifically, the goal of this program is to provide technical, clinical, and commercialization expertise and resources to this RADx® effort seeking to accelerate the deployment of point-of-care, multiplex, lesion-based tests that may include detection of Mpox, Herpes simplex 1 and 2, Varicella zoster, and T. pallidum.
Hepatitis C
In collaboration with the U.S. Food and Drug Administration (FDA), the NIH RADx® Tech–like program solicited proposals to accelerate the validation, regulatory authorization, and commercialization of innovative point-of-care (POC) tests for Hepatitis C virus (HCV) RNA detection and quantitation. The Independent Test Assessment Program (ITAP) will help accelerate the validation, regulatory authorization, and commercialization of select HCV RNA POC diagnostics.
Cancer Screening Research Network
The National Cancer Institute (NCI) established a new Cancer Screening Research Network (CSRN) to conduct clinical trials and studies focused on cancer screening. The network will consist of three Hubs: Accrual, Enrollment, and Screening Site (ACCESS); a Statistics and Data Management Center (SDMC); and a Coordinating and Communication Center (CCC). The CSRN will conduct rigorous, multi-center cancer screening trials and studies with large heterogeneous populations in a variety of healthcare settings, with the ultimate goal of reducing cancer incidence and cancer-related morbidity and mortality. Early screening provides a unique opportunity to diagnose cancers and pre-cancerous lesions before symptoms develop.
New emerging technologies, including Multi-Cancer Detection assays (MCDs), are rapidly gaining traction for commercial availability. As an initial effort, the CSRN will develop a feasibility study (the Vanguard study), to inform the future design of a platform trial to evaluate multiple different technologies for cancer screening in a flexible yet rigorous manner. This study will set the framework for future large-scale clinical trials and other studies developed to assess a variety of cancer screening modalities. The CSRN will utilize the NCI Clinical Trials Infrastructure, which includes a variety of integrated electronic systems, applications, and processes—which together facilitate the conduct of cancer clinical trials.
Read more about the Cancer Screening Research Network.
What Is VentureWell’s Role in RADx®-Style Programs?
VentureWell serves as a critical facilitator within the NIH’s RADx® and RADx® Tech–type program initiatives by leveraging its network and expertise to identify, assess, select, and contract vendors and professional service consultants across many areas in the healthcare space.
Our support services provide vital infrastructure and commercialization expertise for RADx® innovators, aiding in the development of home-based or point-of-care diagnostic devices, wearables, and other remote sensing technologies to improve healthcare across the country.
VentureWell also provides award management support. Through our award management program, VentureWell negotiates, executes, and manages awards to qualified COVID-19 innovator companies and helps them move closer to commercialization of their diagnostic technologies.