Solicitations - JHU

Solicitations

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

Purpose

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. These criteria are derived from the GAITS (Guidance and Impact Tracking System).

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.

*In 2022, we especially encourage applications that focus on the detection of syphilis (Treponema pallidum), though we will review all applications that fit the solicitation.

Minimum Requirements for POCT for STDs

Successful applications will describe the development of tests which minimally meet the  criteria in Table 1.

Table 1: 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.

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

Submissions

The solicitation and access to the application are posted on the Center’s Point-of-Care Technologies Research Network (POCTRN) funding page.

Expression of Interest (EoIs) applications are required and open to all applicants. EoIs will be evaluated to determine from which applicants full proposals will be invited. Only invited full proposals will be accepted and reviewed.

Expression of Interest 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. Submissions must be time-stamped by the submission system prior to or at the cut-off date and time listed in Table 2: Key Dates for Application and Anticipated Award Deadlines. Please note that all deadlines are in Eastern Standard Time (EST) or Eastern Daylight Time (EDT). The Center will not consider proposals which are in the process of submission but not yet submitted prior to the cut-off and not stamped as received in time. 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.

Table 2: Key Dates for Application and Anticipated Award Deadlines:

Solicitation Release

January 19, 2022

Expression of Interests Due

March 14, 2022, 5 pm EDT

Invitations for Full Fast Track Proposals sent

April 4, 2022

Full Fast Track Proposals Due

May 16, 2022, 5 pm EDT

Notification of Successful Applicants

July 18, 2022

Review Notification to all Applicants

July 25, 2022

Funds Awarded (anticipated)

Approximately 60 days following notifications of successful application

Questions regarding this solicitation may be sent to: POCT-STD@jhuapl.edu up to 48 hours before the submission date and time. Please include the words “Solicitation POCT4STD” in the subject line and allow up to 48 hours for responses.

The deadline for applications has passed

Overview Information Funding Opportunity Description Print Solicitation