Funding Opportunity

The Johns Hopkins University Center for Innovative Diagnostics for Infectious Diseases (the Center) is seeking to facilitate the development of novel detection technologies for point-of-care tests (POCT). The targets for these POCT are limited to sexually transmitted infections (STIs) including infections diagnosed in blood such as Hepatitis C virus (HCV), syphilis, and Human Immunodeficiency virus (HIV).

*In 2024, we especially encourage applications that focus on the blood detection of HIV, syphilis, and/or HCV RNA, though we will review all applications that fit the solicitation.

Successful applicants will describe improvements to proposed devices which minimally meet or exceed the current clinically accepted assays (i.e., “gold standard”). The proposed device should have achieved a Technology Readiness Level > 3 (greater than proof of concept) as described by CIMIT's GAITS (Guidance and Impact Tracking System). Technological criteria associated with this domain include development of a prototype(s), supportive experimental results, and institutional IP disclosure. 

Successful applicants will describe the developmental goals of their device with relevance to a “use case”. A “use case” is defined by the population of patients who would benefit from the device and the end user needs for which development is intended. For example, a “use case” could be a public health clinic with limited funds available for reimbursement of a test. The end user needs and support for reimbursement cost could vary based on whether the clinic is inside or outside the US.  

While the types of POC technologies considered will include both novel detection technologies and novel enabling technologies, this solicitation is seeking primarily to provide “tactical” funding to accelerate development of novel detection technologies. Detection technologies are defined as technologies in which the device can identify and discriminate the infectious agent using a clinically relevant sample. Enabling technologies are defined as technologies, which can be used with currently available diagnostic rapid tests to improve and simplify sample preparation or rapid development of new specific reagents (antibodies, aptamers, etc.) for use in existing detectors with potential to be transferred into a health care setting or home use. 

“Tactical” funding is directed to a critical experiment(s) which, if successful, would 1) provide preliminary data, 2) enable first demonstration, 3) verify proof of principle/concept or 4) complete a seedling effort to enable organizations to seek additional funding for more robust technology development. These de-risking awards are narrow in scope but should open the path to more robust and detailed development or integration of detection and/or enabling technology.  

Minimum Technological Requirements for Application

Successful applications will describe the development of tests which minimally meet the following requirements:

• Affordable: Test should be affordable with retail cost to “use case” not to exceed $30/test, preferably cost of goods < $5.
• Sensitive: Diagnostic will have a sensitivity of at least 90% of a current clinically accepted assay.
• Specific: Test will have a specificity of at least 95% of a current clinically accepted assay.
• User-friendly: Diagnostic will have a low labor burden, be CLIA waivable, and include no more than three steps.
• Rapid: Test will have a sample to result time of less than 30 min, preferably <20 min.
• No additional equipment needed: Diagnostic will include a low power (battery operated to 120V) reader with little to no sample prep. (i.e., sample-to-answer)
• Portable: Test must consist of a small benchtop to handheld device < 5lb and be deliverable to those in need. 

Diagnostic Targets

Proposed POCT can detect single or multiple targets, however, multiplex assays which can detect Treponema pallidum (syphilis), symptomatically related STDs such as Chlamydia trachomatis (Ct), Neisseria gonorrhoeae (Ng), and Trichomonas vaginalis (Tv), or multiplexed bloodborne pathogens including HIV and HCV RNA are preferred. While preference is given to the targets named above, we welcome proposals that target other STDs or bloodborne pathogens.

Proposed test can detect any of the following: 

• genetic or protein-based components of the organism,
• general optical or electrical characteristics unique to the organism, and/or
• surrogate markers with established clinical significance. 

Acceptable Use Cases

The four use cases listed below are acceptable for proposals if they adhere to the following conditions:

• Emergency Department in which the average patient visit time is > 4 hr and the proposed test requires up to 120V commercial power with cold storage down to -20C possible.
• Urgent Care or Community Clinics where the average patient visit time is < 1 hr (20 min to be within clinical encounter) and the proposed test requires up to 120V commercial power with variable cold storage possibilities (-20° C, 4° C, or none).
• Home (over the counter) testing with an average patient visit time < 25 min with the proposed diagnostic requiring rechargeable battery power and unreliable cold storage below 4° C.
• Low Resource Setting Clinic where patient visit times are < 1 hr and proposed test must be powered by non-rechargeable batteries and use temperature stable reagents as no reliable cold storage is available. 

Regardless of the target(s) or platform proposed, proposals should limit the work to tasks that can be completed within 6-9 months.

Submissions

Access to the application is posted here.  

Expression of Interest (EOI) letters are required and open to all applicants. EOI letters will be evaluated to determine which applicants will be invited to submit full proposals. Only invited full proposals will be accepted and reviewed. EOI forms, invited full proposal forms, and associated PDF files may be accessed at the funding page link noted above. Only electronic submissions will be accepted. EOI letters and full proposals must be submitted online through CoLab. Submissions must be time-stamped by the submission system prior to or at the cut-off date and time listed in the timeline section.

Please note that all deadlines are end of day. Information that is relevant to your organization’s intellectual property should be marked “Business Sensitive” or “Proprietary.” Classified information or markings such as the word “Sensitive” alone must not be used in any part of the submission.

Sponsoring Organizations

All awards will be contracted by the Johns Hopkins University School of Medicine Center for Innovative Diagnostics for Infectious Diseases.

Mechanism of Support

All sub awards to successful applicants will use funding from the National Institutes of Health (NIH), National Institute of Biomedical Imaging and Bioengineering (NIBIB), under the authority of the parent grant mechanism administered under the Point-of-Care Technologies Research Network Centers U54. All NIH guidelines, terms, and conditions of award stated in this parent RFA apply to this funding opportunity. Foreign entities may apply to this solicitation as permitted by NIH.

Funds Available

We anticipate funding three sub awards for this solicitation. Each subaward will be funded at $150,000 (direct and indirect costs) for the duration for the proposal. The Center may award up to three $50,000 USD sub awards with a period of performance not to exceed six months for a recipient who successfully completes research milestones for their first award. The amount of total funding available for a recipient in a 12-month period will not exceed $200,000 USD.

Eligibility

Applications from all sources, including domestic or foreign, public, or private, and non-profit or for-profit, will be considered. Awards under this solicitation may be made only to NIH-eligible applicants. Details regarding specific requirements can be found in the NIH Grants Policy Statement Part II: Terms and Conditions of the NIH Grant Awards. Foreign parties (governments, universities, corporations, or individuals) will be screened against the various US government restricted party lists as required by NIH guidelines.

Solicitation Policies

Please note that secondary subcontracts under this funding program are not permitted. However, proposals that split award funding directly between two institutions are permitted. Each co-applicant institution must submit budget information under the same proposal submission. Proposals accepted for award may be required to provide additional budget information.

Animal studies may not be proposed under this solicitation.

Testing of human clinical samples is permitted. De-identified clinical materials can be requested from Johns Hopkins Medical Institutions under existing approved institutional research protocols. The need for de-identified clinical material should be noted in the proposal and associated with a specific task. Both benchtop evaluations and pre-clinical clinical prospective pilot studies can also be requested and budgeted which will be done at Johns Hopkins University. Applicants should contact the Center to discuss use of clinical samples and pre-clinical pilot prior to submission of their application.

General Award Information

Awardees will regularly meet with Center leadership to review progress and achievement of critical milestones and deliverables. As required by NIBIB, the Center will track the progress of awards using CIMIT's GAITS.