Solicitations - JHU

Improvements to Rapid Simple Point-of-Care Tests (POCT) For Sexually Transmitted Diseases (STDs)

2020 Tactical Funding Solicitation


The Johns Hopkins University Center for Point-of-Care Technologies Research for Sexually Transmitted 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 diseases (STDs). Other infectious diseases will not be considered for this award.

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 level of technological maturity equivalent to proof of concept at a minimum. The three technological criteria associated with this domain are 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.  

Successful applications will describe the development of tests which minimally meet the ASSURED criteria.

Description of POCT requirements based on ASSURED criteria1

ASSURED criteria1 Assay Criteria Criteria Description
Affordable Low cost
  • “Use case” dependent but not to exceed $30 USDa/test
Sensitive Sensitivity
  • Within 90% of current clinically accepted assay

Specific

Specificity
  • Within 90% of current clinically accepted assay
User-friendly Low labor burden/CLIA waivable
  • As few manual steps as possible/must be 3 steps or less for CLIA waived test
Robust and rapid Turn-around time (TAT)
  • TAT < 30 min (sample to result)
Equipment-free Low power reader +no/little sample prep
  • “Use case” dependent: Reader (120v to battery operated) / sample prep integrated into reader
Deliverable to those in need Portable device
  • Use case” dependent: Small bench top to hand held (<5 lbs.)

a United States dollars

Proposed POCT can detect single STDs or multiple STD targets, however, multiplex assays which can detect symptomatically related STDs such as Chlamydia trachomatis (Ct), Neisseria gonorrhoeae (Ng), Trichomonas vaginalis (Tv), and Mycoplasma genitalium (Mg), are preferred. This solicitation is not limited to the four targets named. Proposals are encouraged which detect STDs other than those listed above, particularly syphilis.

Proposals should limit the work to tasks that can be completed within 6 months.

Overview Information Funding Opportunity Description Application Process

Key Dates for Application and Anticipated Award Deadlines

Solicitation Release January 22, 2020
Expression of Interests Due March 2, 2020, 5 pm EST
Invitations for Full Fast Track Proposals April 1, 2020
Full Fast Track Proposals Due September 1, 2020, 5 pm EDT
Notification of Successful Applicants TBD
Review Notification to all Applicants TBD
Funds Awarded (anticipated) Approximately 60 days following notifications of successful application
 
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