Purpose

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 diagnostic tests to be used in clinical settings or for home use (over the counter). The targets for these POCTs are limited to sexually transmitted infections (STIs) and bloodborne infections –particularly bloodborne infections which may be sexually transmitted (e.g. hepatitis, syphilis).

*In 2026, we especially encourage applications that focus on: 

1. A point of care test for syphilis with emphasis on lipoidal (non-treponemal) antibodies including quantitative outputs for diagnosing adult and congenital syphilis.
2. A molecular point of care test for detection of bloodborne pathogens.
3. A point of care device for processing whole blood into plasma without centrifugation to facilitate point of care diagnosis of bloodborne infections.
4. Incorporating Neisseria gonorrhoeae (NG) antimicrobial resistance markers in an existing multiplex point of care test for detection of a combination of NG, Chlamydia trachomatis, or Trichomonas vaginalis.

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 the 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. It is suggested that applicants utilize the online System Analysis Systems Engineering tool on the JHU CIDID website to confirm the TRL of their device.

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 or an over-the-counter test intended for use at home. The end user needs and support for reimbursement cost could vary based on where the clinic is located.    

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 collection and 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. 

Funds Available

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 not apply to this solicitation.  

Number of Projects Anticipated

We anticipate funding three sub awards for this solicitation. Each subaward will be funded at $100,000 (direct and indirect costs) for the duration of 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 $150,000 USD.

Clinical Need Addressed and Patient Persona(s)

POC technologies for diagnostics of sexually transmitted and blood-borne infections have undergone a massive transformation within the past decade. The FDA has recently approved two CLIA-waived POC tests for chlamydia and gonorrhea, and there has never been a greater need for more testing for STIs. Adult syphilis rates are very high and congenital syphilis rates have increased alarmingly.¹ Despite modest decreases, chlamydia and gonorrhea rates remain very high. Recent declines may represent insufficient screening for these infections. 

Young people are disproportionately affected by STIS; half of chlamydia, gonorrhea, and syphilis diagnoses given to young adults aged 15-24.¹ Women and their babies are severely impacted by syphilis, other STIs are among the leading causes of infertility in women. MSM are also disproportionately impacted with co-infections of HIV and syphilis common.¹ Traditionally, diagnosis for STIs has focused on swabs for women and urine for men, however expanding to bloodborne pathogens such as Hepatitis B and C would target populations at risk for both STIs and bloodborne pathogens, in addition to aiding HIV and Hepatitis C elimination by 2030. Stigma is associated with infections of both STIs and bloodborne pathogens. By bringing tests to patient side as CLIA-waived or over the counter, it may be possible to make a diagnosis within one clinical encounter. This is crucial to initiation of treatment and management.

Scope

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

1. Affordable. Test should be affordable with retail cost to “use case” not to exceed $30/test, preferably cost of goods < $5.
2. Sensitive. Diagnostic will have a sensitivity of at least 90% of a current clinically accepted assay.
3. Specific. Test will have a specificity of at least 95% of a current clinically accepted assay.
4. User friendly. Diagnostic will have a low labor burden, be CLIA waivable, and include no more than three steps.
5. Rapid. Test will have a sample-to-result time of less than 30 min, preferably <20 min.
6. 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).
7. Portable. Test must consist of a small benchtop to handheld device < 5lb and be deliverable to those in need. 

Maturity

Technologies should be at a Technology Readiness Level of 3 or above. At a minimum, proof of concept should be demonstrated. Concepts which are at the ideation stage are too immature to advance development and benefit from this level of funding. Our Center recommends these applicants to seek funding from NIH and other scientific organizations which support basic science efforts at this level.

Applicant Eligibility

Applications from domestic sources, 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. 

Unique Review Criteria

A separate reviewer’s guidance document and scoring document is provided to external reviewers which allows them to include more narrative inputs for their proposal reviews. 

Unsuccessful applicants will be offered a debrief with comments about application, notified of upcoming new solicitations and center offerings and followed for a year after application. 

1. Center for Disease Control and Prevention. Sexually Transmitted Infections Surveillance, 2024. September 24, 2025.

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