SUMMARY - OVERALL The Center for Innovation in Point-of-Care Technologies for HIV/AIDS and Emerging Infectious Diseases at Northwestern (C-THAN) proposes to remain a member in the Point-of-Care Technologies Research Network (POCTRN) as a Technology Research and Development Center (TRDC). C-THAN will catalyze innovation in diagnostic technologies through a model that enhances complementary strengths to build multidisciplinary partnerships across technology platforms, clinical, regulatory and commercialization domains with a specific focus on HIV/AIDS and emerging infectious diseases in low- and middle-income countries (LMICs). The C-THAN structure will incorporate clinical, and user needs in the development process while providing expertise and resources to address early barriers to technologic development, validation, and commercialization. The scope of work entails: 1) assessment of unmet clinical needs in POC testing for HIV/AIDS, its co-morbidities, and emerging infectious diseases; 2) develop relevant solicitation topics to address unmet clinical needs; 3) award and manage sub-award projects made by C-THAN; 4) collaborate with relevant scientists, physicians, researchers and engineers; 5) develop essential technical, clinical, industrial and regulatory partnerships; 6) conduct clinical studies and/or provide access to specimens for validation testing of prototype devices; and 7) create training opportunities for technical developers and other stakeholders related to the development of POC and home-based devices. The range of technologies will include POC devices for detection of infection and monitoring of HIV/AIDS and its common potentially fatal co- morbidities including tuberculosis (TB), non-tuberculous mycobacterium (NTM), hepatitis B (HBV), hepatitis C (HCV) and HIV-associated malignancies. Furthermore, emerging, and re-emerging infectious diseases will be addressed by applying our strategy of addressing the urgent diagnostic need of POC testing for SARS-CoV-2 and other emerging infections such as mpox virus, Ebola, Lassa Fever, and Rift Valley Fever, among others. The United Nations Program on HIV and AIDS (UNAIDS) has set the ambitious goal of achieving a 95% detection rate for HIV, placing 95% of those individuals on treatment, and achieving 95% viral suppression in those that are treated. The major premise of this renewal proposal is that these goals will not be met without augmenting the current diagnostic platforms for HIV, its co-morbidities, and emerging infectious diseases with POCs that are affordable, rapid, and easy to use in LMICs requiring minimal skill and maintenance. An emphasis will be directed to specific technologic domains by establishing four working groups (WG) in molecular, lateral flow, synthetic biology, and product engineering. We will leverage the dynamic and productive collaborations established by Northwestern in Africa at nine academic centers in Nigeria, Mali, Senegal, Tanzania, and South Africa.

The Center for Point-of-Care Technologies for HIV/AIDS and Emerging Infectious Diseases at Northwestern (C-THAN) will catalyze innovation in diagnostic technologies through a model that enhances complementary strengths to build multidisciplinary partnerships across technology platforms, clinical, regulatory and commercialization domains relevant to the needs of low- and middle-income countries.