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Developing Point-of-Care Tests for Chlamydia and Other STDs
The Johns Hopkins Center for Point-of-Care Tests for Sexually Transmitted Diseases is seeking the development of novel sampling and detection technologies for point-of-care tests.
Dr. Joany Jackman is looking at promising new technologies in various stages of development.
Send Dr. Jackman and Dr. Charlotte Gaydos an email by selecting this link.
This document ( PDF ) describes the types of engagement support and interaction offered by the Johns Hopkins University Center for Point-of-Care Tests for Sexually Transmitted Diseases to organizations (which include commercial or corporate businesses, academic institutions, research or technology developers, not-for-profit organizations, nonprofit organizations, and foreign entities), and describes the decision structure used to determine the types of support for which an organization qualifies.
The Johns Hopkins University (JHU) Center for Point-of-Care Tests (POCT) for Sexually Transmitted Diseases (STDs) is a participant in the National Institute of Biomedical Imaging and Bioengineering (NIBIB) Point-of-Care Technologies Research Network. "The NIBIB created the Point-of-Care Technologies Research Network (POCTRN) in 2007. POCTRN's purpose is to drive the development of appropriate point-of-care diagnostic technologies through collaborative efforts that merge scientific and technological capabilities with clinical need." 2
A summary of the POCTRN's mission can be found on our Center's website page1, Point-of-Care Technologies Research Network, and more detailed information about NIBIB, the POCTRN, and resources for researchers3 involved in NIH funded research may be found at the following websites:
Organizations involved with POCT development are encouraged to review information on these sites in addition to the information on the JHU Center for POCT for STDs website pages.
B. Types of Engagement and Qualifications:
The Center provides seven types of formal interaction with organizations. As organizations engage the Center, each will meet with the Director and staff members for an entry interview. The purpose of this interview is to determine the level of maturity of the technology and its applicability to STDs, and to determine the immediate needs of the organization. This information may be used in real time to provide interaction with organizations. Further descriptions of the seven engagement types are described below.
1. Consultation with Center members in order to provide design, assay implementation or product placement guidance for a particular technology. This type of interaction is offered to provide candid analysis and expert opinion regarding a particular sampling approach or detection strategy as well as potential market placement. Consultation is available to early through late stage technology development, as well as fully commercialized systems. A Non-Disclosure Agreement (NDA) may be required for this interaction. No costs are associated with this interaction.
How to Qualify: An NDA may be required for this interaction. An organization will contact the Center for specific technical guidance in development. Support in the form of recommendations for critical design features and technology transition characteristics will be provided through formal meetings (inclusive of teleconferences). Design interactions and assay optimization for integration of specific features is available, which is funded directly from the Center. No funds can be taken from companies or organizations to support consultation by Center staff in order to prevent conflict of interest (COI) issues. Other mechanisms to support more detailed development will be funded through mechanisms external to Center funding.
2. De-identified clinical specimens and/or laboratory-grown organisms for testing POC devices. These materials are available to companies with working prototype devices. Device subsystems need not be fully integrated though a plan for full integration should be available. A Material Transfer Agreement (MTA) will be required for this interaction following an assessment of testing and recommendation for samples to be approved by the Center Director or her designee.
How to Qualify: An NDA and MTA will be required for this interaction in addition to an assessment and recommendation for samples approved by the Center Director or her designee. Organizations needing access to proof of concept for clincal samples for their early stage sample preparation technologies or late stage verification of detection technologies may receive up to 10 archival samples for free with application for Center support. More samples as may be required for validation and/or optimization will be provided at a low cost under the Center's JHU Institutional Review Board (IRB)-approved Exempt Research protocol. Similarly, samples which cannot be provided from archival samples due to limitations of the technology may be provided at low cost if they can be provided under the current IRB-aproved protocol. More extensive sampling, which would require a new IRB-approved protocol, is beyond the scope of Center funding, but these samples may be provided under another funding mechanism such as a Small Business Innovation Research (SBIR) award. A limit of 100 samples will be instituted for each organization's development process. All organizations must provide a report of the distribution and/or destruction of specimens and results obtained. Unused samples remaining after 12 months must be returned to the Center or destroyed. Additional samples may be made available based on proof of progress provided by the organization to Center Director and staff for evaluation. Data generated fromo these studies will be the property of the participating organization; however, the Center will be included in any open source publications of these data. Data generated will be required to be included in any limited distribution formal government documents as required by Federal Acquisition Regulation (FAR) standards. These will include but are not limited to final reports required at the conclusion of IRB approved studies and annual or final FOUO reports to government sponsors.
3. Collaboration for external funding such as an SBIR or other funding agencies. An NDA, IRB-approved protocol, and MTA may be required for these interactions. An organization meeting the requirements to apply for government or private funding may request these interactions in order to establish a link between the organization and expertise in the area of sexually transmitted infection (STI) diagnosis. Letters of support will be provided. No costs are associated with this interaction.
How to Qualify: An NDA, IRB-approved protocol, and MTA may be required for these interactions. The Center Director will make the decision on a case by case basis regarding participation and letters of support for SBIR and other funding applications. Organizations should contact the Center with at least one month of lead time before requesting this type of support.
4. Participation in focus groups or WALEX activities to support technology development and commercialization. The Warfare Analysis Laboratory Exercise (WALEX) is a mechanism unique to the JHU Center which has been used to obtain, prioritize, and integrate technology needs across professional disciplines. In this way it differs from a focus group which typically samples opinion leaders from the same discipline. WALEX allows interaction and recording of the total program through voice and compupter input and application of forced choice surveys in order to down-select the most practical technology formats. Organizations requesting this type of collaboration should be prepared to provide sufficient information regarding a prototype and its function to allow focus groups and WALEX participants to effectively evaluate the needs and anticipated use (market placement) of the technology. Very early stage pre-prototype development is not a candidate for this type of support. No costs are associated with this interaction.
How to Qualify: Organizations may request this type of collaboration from the Center. The Center may pool companies into a single effort involving focus groups, a WALEX, or both. Funding support for these activities will derive from the Center's funding or supplemental funding. The results of these efforts will be candidates for publication by the Center and participating companies. Qualification for this support will be determined from the initial interview and the maturity of the product under development. Solutions to critical developmental decisions which may help in the commercialization of the technology should be the outcome of these efforts.
5. POC or other device testing in the research laboratory or pilot testing in clinics associated with the Center. An NDA and IRB-approved protocol will be required for these interactions. Devices which are more mature in their development are candidates. Enabling technologies which do not include a detection device are candidates; however, organizations must identify the detection technology or platform to be paired with their technology. Additional financial support in the form of patient incentive/sample collection reimbursements, reagents, devices and training may be required depending on the level of effort requested from the Center.
How to Qualify: An NDA and IRB-approved protocol(s) will be required for these interactions. Minimally, the JHU IRB must approve the study though organizations may have requirements for their own approvals. Organizations are encouraged to provide the reagents and devices to the Center for evaluation in the research laboratory or clinical settings. Companies qualifying for this support should have a similar device which is 510K approved, US Food and Drug Administration (FDA) approved, or in the path for FDA approval and/or European Community also known as European Compliance (CE) marking. Limited funds (< $5K) to support reagents may be provided, but the Center will not purchase devices or other non-disposable materials. Publications from these studies will be encouraged. Data generated from these studies will be the property of the participating organization; however, the Center will be included in any open source publications of these data. Data generated will be required to be included in any limited distribution formal government documents as required by FAR standards. These will include but are not limited to final reports required at the conclusion of IRB approved studies and annual or final FOUO reports to government sponsors.
6. Access to the Technology Watch Database (TWD). Access will be provided to all companies, organizations, and individuals with interest in POCT for STDs. Other Centers within the Point-of-Care Technologies Research Network (POCTRN) will also be candidates for access. Registration will be required for access. There is no charge to access this database.
How to Qualify: Registration will be required for access. This will be offered free to all organizations that request access from the Center. The intent is that this database will identify comparable technologies for organizations with which to develop their proposals and technology design. In some cases, the TWD will assist companies by providing a potential teaming resource for complementary technologies. No specific developmental requirements are needed to qualify for this type of assistance. The TWD is intended to provide a central information source regarding companies and individuals. Integrated into the database is open source information on device characteristics, company contact, and developmental stage. Access to TWD will provide users the ability to find and understand competing technologies, locate collaborative technologies for which integration between organizations may benefit, and provide a mechanism to follow multiple technologies as they advance their development towards full commercialization as POCT.
7. Center derived funding of critical experiments. Companies and organizations must be able to receive funding through a federally regulated subcontract mechanism. Companies or organizations which are restricted from receiving federal grants or contracts may not compete for this type of support. Funding is open to all stages of technology development beyond concept stage but is narrow in its focus and is intended to provide tactical support for critical path experiments. An NDA, a formal application and legal contract will required for these interactions. There is no fee required to apply for funding support.
How to Qualify: Companies and organizations in need of critical funding will be evaluated on a case by case basis. A key requirement to receive this type of support is a formal application and legal contract with a budget request. Additionally, this application will require the identification of a likely path to obtain significant funding, which will enable development or transition of the technology to further application or commercialization. A pre-application quad chart may be presented to the Center by organizations receiving consultation support prior to making an application. Details regarding the format of the proposal are described in Section C. The decision to fund an organization may include one of the following critical path indicators:
a) A rejected SBIR proposal which scores in the top 50% of submitted proposals that details an essential gap. A clear experimental plan which addresses the minimal experimental proof required and a path for resubmission of SBIR or identification of new funding source is required.
b) Need for STD demonstration. This involves transition of a device or application shown to be successful for other infectious disease detection applications and adapted to detection of an STD, in which modest re-engineering is required. This support is beyond the support offered for samples or reagents outline above.
c) Initial interactive funding in which a team of companies (two or more) have identified a path to integrate their respective technologies into a single POC application. Future pathways to funding using intra-organizational support and future pathways to licensing decisions based on anticipated results should be defined in the proposal for this type of funding support.
d) Other efforts in which critical experiments are defined that will lead to future significant funding pathways which cannot be predicted. Justification must be included in these proposals which define the critical path, sources of future funding, and description of efforts to obtain funding. Proof of concept and other basic research are very early efforts and beyond the scope for this type of funding.
C. Required Components Proposal for Center Derived Funding
1. General Information. Proposals must be limited to 8 pages exclusive of the cover page. The cover page should include the title of proposal, contact information (address, email, phone[s]) for the Principal Investigator, Organization and Financial or Contracting Officer.
Funds are limited to $50,000 and a period of performance (POP) not to exceed 12 months. Shorted POP (i.e. 6 month or less) is encouraged. Companies may not receive more than two consecutive awards (each no more than 6 months in a calendar year).
A running title should be included as a header on all pages. All pages but the title page should be numbered in the footer.
Proposals will be reviewed as received. Submitters will receive contact regarding their proposal within 21 days of submission.
2. Format of Proposal:
I. Cover Page
II. Project Objectives
III. Impact Statement
IV. Impact on the JHU Center for POCT for STDs
V. Tactical Funding Path forward towards Commercialization
VI. Innovative Claims, Technical Rationale and Approach
VII. Prior Work and Background
VIII. Detailed Technical Approach and Statement of Work
IX. Project Milestones and Deliverables
X. Budget and Timeline Schedule
XI. Organization Background and Future Development Pathway
3. Rules for "Go/No Go" Decision for Progress-based Funding. After initial funding, the decision as to whether to fund any follow-on requests will be made after deliverables are discussed with the members of the POC Center.