Solicitations - C-THAN

Solicitations

2021 Award Competition: Development of Point-Of-Care Testing for HIV and Co-Morbidities for Use in Low and Middle Income Countries

The application deadline has passed for this solicitation.

Date: 1/18/2021
C-THAN Contact: Sally McFall, Ph.D., Director of Technology Development/Refinement Core

Email: s-mcfall@northwestern.edu

CHICAGO, IL – The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN) seeks collaborative research projects to develop novel point-of-care technologies (POCT) aimed at improving diagnosis and treatment monitoring of HIV/AIDS in low- and middle-income countries (LMIC).  If successful, projects should be viable candidates for commercial development.

About C-THAN

C-THAN was funded in 2018 for a five-year period by the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Point-of-Care Technologies Research Network (POCTRN), Fogarty International Center (FIC) and the Office of AIDS Research. C-THAN’s mission is to support the development and facilitate commercialization of a pipeline of POCT designed to meet the clinical needs of people who live with HIV/AIDS in LMIC.

Background

HIV disproportionately impacts low- and middle-income countries (LMICs) with the heaviest burden in sub-Saharan Africa.  In 2019, 67% of people living with HIV/AIDS (PLWHA), 57% of new HIV infections and 64% of HIV-related deaths were from this region of the world. The Center for Innovation in Point-of-Care Technologies for HIV/AIDS at Northwestern University (C-THAN) was founded to support the development of vital point-of-care technologies (POCT) specifically designed for patient management of PLWHA in LMICs with emphasis on the diagnostic needs of sub-Saharan Africa.

We seek to support projects designed for settings with limited medical infrastructure including restricted access to electricity, refrigeration and/or central water supply. Relevant projects considered for funding include, but are not limited to, diagnostic assays or technologies for HIV/AIDS disease and its comorbidities (e.g., tuberculosis, viral hepatitis, related cancers, related cardiovascular diseases), treatment-related diagnostics, technologies that can be self-administered for either diagnosis or treatment monitoring, and/or technologies that improve or enable POC test performance.

The focus of this solicitation is to develop POCTs that address one or more of the AIDS Office of Research High Priority Research Areas. The requirements for the test are summarized in the table below:

Design requirements for POCTs

The proposed project must focus on a specific need related to HIV prevention, treatment, or management in an LMIC setting and must show promise for improved health outcomes for those at high risk or living with HIV.

The proposed project may consist of one or more product development activities including: developing and/or refining technology, clinical field testing, establishing test characteristics, obtaining feedback on user steps from end users, obtaining end user assessments, conducting market research on product concepts or working prototypes with distributors, implementers, procurement agencies, policy makers, or other relevant stakeholders, evaluating test implementation, and assessing feasibility.

Relevant technologies that will be considered for funding include, but are not limited to, in vitro diagnostic assays or technologies, treatment-related diagnostic technologies, technologies that can be self-administered, and/or technologies that improve or enable POC test performance. Microfluidic and nanotechnology platforms that are capable of multiplex testing to measure multiple analytes are welcomed.

Maturity

Applicants with a working prototype or an existing assay/device (not necessarily used for the proposed application) and preliminary data to demonstrate its potential for detection, diagnosis, or treatment guidance for HIV and/or its co-morbidities in LMICs will have priority. Minimum preferred maturity levels in the four product development cycle domains:

Technology: proof of concept (3) or preferably proof of feasibility (4)

Regulatory: proof of concept (3) or preferably proof of feasibility (4)

Marketing/Business: proof of concept (3) or preferably proof of feasibility (4)

Clinical: proof of concept (3) or preferably proof of feasibility (4)

Applicant Eligibility

Applications from all sources will be considered including domestic or foreign, public or private, or non-profit or for-profit. Applicants from low- and middle-income countries either independently or in collaboration with developers in high resource countries are encouraged to apply. Teams consisting solely of applicants from low- and middle-income countries will be given special consideration.

Justification

Our mission is to support the development and facilitate commercialization of a pipeline of POCT designed to meet the clinical needs of PLWHA in LMICs. In order to achieve our goals, we will support projects from both US and foreign institutions with preference for those with collaborations/connections that could facilitate eventual field testing, implementation evaluations, and manufacturing within LMICs.

Applicants are encouraged to contact C-THAN to discuss potential collaborations within the network.

Preferred applications will:

  • Be based upon a working prototype (for new technologies) or an existing device (which will serve as the base for adaptation)
  • Generate preliminary data to demonstrate its potential for detection, diagnosis, or treatment guidance for HIV and/or its co-morbidities in LMICs
  • Demonstrate test characteristics such as clinical sensitivity and specificity, feasibility or usability for a chosen clinical need comparable to an existing technology, device, or assay in clinical practice.

General characteristics

Usable for patient management in LMIC clinic conditions, non- to minimally-invasive, low cost (the cost of test should be comparable to or lower than the local median daily income, the local cost of HIV medication dose, etc.) user friendly (can be operated by health care workers that receive local training in its operation and maintenance)

Specific Attributes

Portability, operable in locations with limited or no medical infrastructure (limited access to electricity, land-line communication, refrigeration or central water supply)

C-THAN is also receptive to proposals from industry with commercially available testing devices that have not been optimized to address the requirements listed above. The application must detail the limitations of the currently available system relative to use in LMIC or in HIV/AIDS priority topics and describe the proposed approach to resolution of these limitations.

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The application deadline has passed for this solicitation.