JOHNS HOPKINS UNIVERSITY
CENTER FOR POINT-OF-CARE TESTS
FOR SEXUALLY TRANSMITTED DISEASES
ANNOUNCEMENT OF FUNDING OPPORTUNITY
PART 1. OVERVIEW INFORMATION
1. A. Solicitation Title
POINT OF CARE TESTS FOR CHLAMYDIA AND OTHER STDS
1. B. Sponsoring Organizations
Johns Hopkins University Applied Physics Laboratory, member of the Johns Hopkins
Center for STD Point-of-Care Tests.
1. C. Solicitation Release Site
http://www.hopkinsmedicine.org/Medicine/std/2015_funding_announcement/index.html
1. D. Key Dates and Deadlines
Application and Anticipated Award Deadlines:
Solicitation Release
On or before July 1, 2015
Full Fast Track Proposals Due
July 23, 2015; October 7, 2015;
December 16, 2015 by 4 pm EST/ET
Approximately 112 days following
submission
Approximately 120 days following
submission
Approximately 30 days following
notification of successful application
(anticipated)
Notification of Successful Applicants
Review Notification to all Applicants
Funds Awarded
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1. E. Purpose
The Johns Hopkins Center Point-of-Care Tests for STDs (JHU C POCT STD) is seeking
to facilitate the development of novel detection technologies for Point of Care Tests.
Successful applications will describe the development of tests which minimally:
 can detect less than 5,000 elementary bodies of chlamydia/ml
 are rapid (time from sample to result under 4 hours)
 have low-labor burden for sample preparation and assay, and
 will be low cost (under $30/test).
Multiplex assays which can detect chlamydia as well as other sexually transmitted
diseases are encouraged.
1. F. Submissions
The solicitation will be posted at http://www.hopkinsmedicine.org/Medicine/std/.
Look for the link on the menu labeled ANNOUNCEMENT OF 2015-2016 FUNDING
OPPORTUNITIES for the 2015 solicitation. Past solicitations and descriptions of
winning proposals are also posted on the website. It is strongly suggested that applicants
review information on past awardees and past announcements when preparing their
proposal.
Potential applicants are invited and encouraged to discuss their proposals with Center
staff prior to the solicitation closing date. Proposals are not reviewed for funding by
Center staff but are reviewed by external scientific consultants who are independent from
the Center.
PDF files may be uploaded and sent by email to: POCT-STD@jhuapl.edu. Only
electronic submissions are accepted. Proposals must be electronically time stamped as
received prior to or at the time listed above under 1. D. Key Dates and Deadlines. JHU
APL is not responsible for proposals which are sent before but not time-stamped as
received by the time listed. These proposals will be considered late and not considered
for review. The subject line should state “Proposal for POCT-STD” and follow the
requirements listed in this solicitation. Files must be submitted as a single PDF and may
not exceed 48 Megabytes including the message text and all attachments. Information
which is critical to your organization should be marked “Business Sensitive” or
“Proprietary”. Classified information or markings must NOT be used in any part of the
submission.
1. G. Mechanism of Support
The Johns Hopkins Center for Point-of-Care Tests for STDs will subcontract to
successful applicants using funding from the National Institute of Biomedical Imaging
and Bioengineering, NIH, under the authority of the parent RFA-EB06-002, Point-ofCare Technologies Research Network U54 (https://grants.nih.gov/grants/guide/rfafiles/RFA-EB-11-002.html) ). All NIH guidelines, terms and conditions of award stated
in this parent RFA apply to this funding opportunity.
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1. H. Funds Available
APL anticipates awarding at least one contract with a period of performance of six
months at each announcement deadline (see above), dependent of Center funds, for a
maximum single award not to exceed $50,000. A second award for technologies that
successfully complete their first award will be considered, if needed. Organizations may
not be considered for a second award until completion of their first award. The amount of
total funding available for a project will not exceed $100,000 in total for all awards.
1. I. Eligibility
Applications from all sources will be considered including domestic or foreign, public or
private, or non-profit or for-profit. 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 NIH Grant Awards
(http://grants.nih.gov/grants/policy/nihgps_2013/nihgps_2013.pdf).
Foreign parties (governments, universities, corporations, or individuals) will be screened
against the various US Government restricted party lists. These lists include persons that
have been debarred from exporting or US government contracting, Government-known
terrorists and their supporters, narcotics traffickers, proliferators of weapons of mass
destruction, and other parties. The JHU APL Contracts and Procurement Groups screen
companies prior to entering into a contract with a foreign company, and prior to sending a
request for proposal to foreign vendors.
1. J. Solicitation Policies
Please note that NIH regulations prohibit secondary subcontracts under this funding
program. While sub-awards of any type are prohibited, proposals that split award funding
directly to two institutions are permitted under one proposal. Each co-applicant institution
must submit budget information under the same proposal submission.
Details describing the full proposal processes for this application can be found under
sections 3.B and 3.C below, respectively. All budget information prior to final proposal
award must be consistent with the original NIH award guidelines for this solicitation
which can be found at: http://grants.nih.gov/grants/guide/rfa-files/RFA-EB-11-002.html.
Proposals accepted for award will be requested to provide additional budget information.
Animal studies and human clinical trials may not be proposed under this solicitation.
Testing of human clinical samples is not permitted for assays developed under this
protocol with the exception of use of de-identified clinical materials provided by Johns
Hopkins Medical Institutes under their protocol. Due to the rigorous development
schedule anticipated for proposals, the time to gain approval for animal and human
studies at both proposer’s home institutions and by The Johns Hopkins Medicine
Institutional Review Board would be incompatible with the needs and anticipated funding
levels of this program.
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PART 2: FUNDING OPPORTUNITY DESCRIPTION
2. A. Background
Under an award from the National Institute of Biomedical Imaging and Bioengineering
(NIBIB) to establish a Center to coordinate development, clinical evaluation, and
reduction to practice of new POC devices, the Johns Hopkins University School of
Medicine has created the Johns Hopkins Center for Point-of-Care Tests for STDs (JHU C
POCT STD). This Center is a collaboration between the Johns Hopkins University
School of Medicine (SOM), the Johns Hopkins University Applied Physics Laboratory
(JHU/APL), the University of Maryland Baltimore County (UMBC), and the University
of Cincinnati. The technologies are intended to bridge the gap in current biomedical
sensors used in laboratory or research settings for use at the bedside, in the clinic or in the
home care scenario. The goal of the Center is the development of integrated systems that
address unmet POC testing clinical needs for Sexually Transmitted Disease (STDs). The
need to develop acceptable and more easily available POCT for diagnosing sexually
transmitted diseases for all high-risk populations is highly significant. These infections
are particularly hazardous to women since many, if not most, infections are asymptomatic
and only detected through screening or presentation by infected women for testing if they
are notified of sexual contacts to infected partners or they perceive themselves at-risk.
Five of the top ten reportable diseases to the Centers for Disease Control and Prevention
(CDC) in the United States are STDs.
Point of Care diagnostics can include tests for rapid diagnosis in the Emergency
Department (ED) in which the time from sample to result is four hours or less,
diagnostics for rapid diagnosis in a community clinic or non-traditional health care
setting in which the time from sample to result is less than one hour and for the home
testing market in which the time from sample to result should be less than 15 minutes.
There is an additional need for POCT for resource-limited settings, such as developing
countries. It should be noted that the user (the person conducting the test) is significantly
different in each of these scenarios and may encompass the medical doctor, trained health
professional, or lay person with no medical background.
2. B. Research Objectives
While the types of POC technologies considered will include both novel detection
technologies and novel enabling technologies, this initial solicitation is seeking primarily
to provide “tactical” funding to develop or improve on novel detection technologies.
“Tactical funding” is described as funding directed to a critical experiment(s) which if
successful would 1) provide preliminary data, 2) enable first demonstration, 3) verify
proof of principal/concept or 4) complete a seedling effort to enable organizations to seek
additional funding for more robust technology development. These awards while narrow
in scope if successful should open the path to more robust and detailed development of a
detection or enabling technology or integration of both.
Detection technologies are defined as technologies in which the device is able to 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
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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.
2. B. 1. Technologies considered for award will include the following features:
a) Currently able to detect Chlamydia trachomatis
or
b) Demonstrated ability to rapidly detect pathogens similar to Chlamydia, in
addition to other important sexually transmitted infections such as Neisseria
gonorrhoeae, Trichomonas vaginalis, Treponema pallidum, Haemophilus
ducreyi and Herpes Simplex Virus.
or
c) Detect genetic or protein based components of the organism
or
d) Detect combinations of general optical or electrical characteristics which can
be determined to be unique to the organism.
or
e) Detect surrogate markers as long as the clinical significance of the surrogate
marker is well established.
2.B.2. Wherever possible and appropriate, applicants should address how the institution
currently achieves or expects to achieve performance metrics required for POCT for
STDs. Evaluation of detection technologies under consideration for award will include
an assessment of the following technology performance metrics:
a) Achieves an analytic detection of less than 5,000 Chlamydia trachomatis
elementary bodies/ml in standard diluents
b) Achieves a sensitivity ≥80% when compared to the current clinical reference
standard.
c) Demonstrates enhanced specificity of the target organism compared to
expected confounding or commensal organisms
d) Demonstrates a detection time from sample collection to result in less than
four hours
e) Performed by experienced user such as a medical professional.
f) Should not include more than 4 steps exclusive of sample acquisition.
g) Must be prepared for storage at room temperature or 4oC for at least 6
months.
h) Assay readout must not be subjective.
i) Provides single sample format for at least one organism (Chlamydia
trachomatis)
j) Tests must include all necessary controls for quality assurance and assay
performance.
Other General Notes about the Research Objectives

Proposals which describe conceptual ideas or theoretical detector data are not
within the scope of this proposal.
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
Proposals that describe component systems which have not been integrated or
breadboard systems with preliminary results are eligible under this solicitation but
must describe specifically how they intend to reach the developmental level
required to participate in clinical studies in future years.

Proposals which describe devices based on detection of surrogate markers will be
considered as long as the clinical significance of the surrogate marker is well
established or supported in the proposal.

Proposals using component based systems where some of the components are
already in use in food, medical or environmental markets should emphasize which
components are under development and which are novel developments.

While preference is given to proposals which can meet the needs of the point of
care test market and limited resource settings as described in the solicitation,
proposals which can meet the needs of other intended user markets, i.e.
Emergency Department, doctor’s offices, or community health clinic will also be
considered.

The development award can be modified for improvement of existing rapid
laboratory tests for use in the clinic or home market.

Batched assays which can be developed for single use assays are acceptable under
this proposal.

Size, weight and storage conditions of assay reagents are not restricted for entry
into clinical evaluation

All devices must work with standard power (115V) or batteries.

Devices which work from batteries should be able to be recharged.
Further details about successful test characteristics
Successful technologies must demonstrate detection of Chlamydia trachomatis (or other
important STDs, as described above). Comparative measures of sensitivity will vary by
organism, however, for the example of Chlamydia, a successful technology would be
expected to achieve an analytic detection of less than 5,000 elementary bodies/ml when
presented in relevant diluents, which include phosphate buffered saline, DEPC treated
water, or TRIS borate buffer. Other acceptable measures of sensitivity would be
technologies that achieve a sensitivity ≥80% when compared to the current clinical
reference standard. For Chlamydia, the current accepted clinical reference standard is an
endocervical NAAT test. The test must show specificity of the organism compared to
expected confounding or commensal organisms. For the example of Chlamydia, the
technology would be expected to differentiate between C. trachomatis, C. pneumoniae
and C. psittaci. Another measure of specificity is a technology that achieves >90%
specificity compared to the current clinical reference standard. It is expected that the preclinical development will include testing the device versus known dilutions of cultured
organisms
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Desired are multiplex detection technologies which can discriminate Chlamydia from
other important STDs including Neisseria spp. and Trichomonas spp. Additional second
tier infections of interest to distinguish include Treponema pallidum, Haemophilus
ducreyi and Herpes Simplex virus (HSV). Successful technologies will achieve an
analytic detection limit for Chlamydia of less than 5,000 organisms/ml when presented in
relevant diluents. If required for the success of the detection technology, concentration
methods for samples must be included as part of the assay protocol. The test must show
specificity of Chlamydia trachomatis when tested against other organisms including, but
not limited to: Neisseria gonorrhoeae, N. lactamica, Escherichia coli, Trichomonas
vaginalis Staphylococcus spp., Acinetobacter spp. Candida albicans
The test must have a detection time from sample collection to result in less than four
hours and have a protocol developed for an experienced user such as a medical
professional. Protocols should be written to eventually accommodate users with at least
an 8th grade reading level. Protocols may be supplemented by up to one day of training
for experienced users. The assay from sample collection to result should not include more
than 4 steps exclusive of sample acquisition. The detector and assay reagents must be
prepared for storage at room temperature or 4oC for at least 6 months. Assays must be
single test assays not batched for multiple subject analysis. Assay readout must not be
subjective but be easy to read using color change readout, digital or graphic formats.
Tests which require the user to interpret single color variations are not acceptable. Tests
must include controls for interpretation of positive and negative values and a control for
verification of assay performance. Proposers should have the ability to provide at least
500-700 individual tests and at least two testing (i.e. reading) devices (if required by the
assay) for clinical evaluation. There are no requirements regarding the final size or
packaging of the device at completion of funding.
2. C. Review Process and Criteria
Proposals which are responsive will specifically address the items noted in 2.B.1 and
2.B.2 as appropriate.
Full proposals will be evaluated for the following:
 Scientific and technical merit
 Appropriately scoped to the amount of funding and period of performance requirements
of this solicitation
 The ability to fulfill the specific research objectives as stated above
• Significance and relevance to the JHU C POCT-STD mission
• Pre-analytical efficiency and rapid analytical speed of assay using laboratory strains
• Sensitivity and specificity compared to gold standard results
• Potential to apply technology to Chlamydia and other STDs using multiplex diagnostic
testing
• Limit of detection
• Ability of the POCT to require storage not lower than 4o C.
• Appropriate quality assurance (e.g. assay and device controls, within
performance/calibration controls for devices)
• Competence and experience of the investigative team
• Bioengineering and research environment in which the work will be performed
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• Likelihood of success when used in one of the scenarios identified as physicians’
offices, Emergency rooms, low resource medical facilities, home care or community
clinics by minimally trained staff
• Practical suitability for use in near-patient applications in ED, clinic or home care
settings
• Incorporation of testing principles or assay improvements that can be reduced to one or
more operating prototypes within the two-year term
• Plan for effective evaluation of the diagnostic method using archived clinical samples
2. D. General Award Information
Awards will be for six months or less. A second 6-month award for technologies that are
successful in their first period of performance will be considered if needed. A technology
monitor from JHU/ APL will meet with successful awardees regularly to review progress
and achievement of critical milestones and deliverables. Awardees are expected to
provide a project update every 30 days of the sub-award period to the technology monitor
and a detailed final report at the end of the sub-award.
PART 3: APPLICATION PROCESS
3. A. General Application Information
The format of the full proposal must include the following:
Format item
Page
Limit
Cover page
(not included in proposal page limit)
1
Technical Proposal and Short Budget
Critical Information
Title, Technical and Financial
Contact and Address Information,
Solicitation Number & Submission
Date, Total Cost
(Section limited to 8 pages)
Suggested Page Limits
Concise statement of technology
development needed and approach
I. Project Objectives
II. Impact Statement
1.5
III. Impact on the JHU Center for
POCT for Sexually Transmitted
Diseases
IV. Tactical Funding Path forward
towards Commercialization
1
V. Innovative Claims, Technical
Rationale and Approach
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How does technical innovation
improve overall diagnosis of STDs?
How does technical innovation
complement mission of JHUCPOCT for STD?
Document successful use or
potential use of technology in
diagnostics
These
two
sections
VII. Detailed Technical Approach and should
Statement of Work (SOW)
not
exceed
4 pages
VIII. Organization Background and 0.5
Future Development Pathway
IX. Project Metrics Plan and Timeline
0.5
of Milestones and Deliverables
VI. Prior Work and Background
X. Summary Budget by Year &
Budget Justification
0.5
Describe scientific or technical
methods used to carry out aims
Describe goal and specific aims
proposed
List expected Milestones and
Deliverables by month as they
apply to the goals and aims
described in the SOW (see below)
Follow form listed (see below)
Pages will be 8.5 x 11 and in a font no smaller than 11 point with 1 inch margins.
Figures and tables are included in the page limits.
Project Milestones, Deliverables and Timeline Schedule Table (sample)
Milestone (M) or Deliverable (D)
Budget Table (sample)
Project Month (not
to exceed Month
6)
Measure of
Success/Completion
Total Budget by Fiscal Year(s)
Period
Category
Total
(all months)
(Oct-Dec 2014)
Period
(Jan- July 2015)
Labor *
Materials
Consumables
Indirect Costs
Total Direct
and Indirect
*In budget narrative list all staff and the number of staff months assigned to this effort.
Note: Subcontracts and equipment are not permitted under this award. Travel may be
permitted if justified as essential to the completion of the work proposed. Travel must be
justified by number of personnel, location and time period.
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3. B. Submission Information
All documents must be uploaded as a single PDF document electronically before the date
and time indicated in the table above (Section 1D). Applicants (and co-applicants if
splitting award between two institutions) may only submit a single proposal under this
announcement but institutions may submit multiple proposals from different applicants at
their facilities.
Questions regarding this solicitation or proposal process can be directed electronically to
joany.jackman@jhuapl.edu at least 7 business days prior to the submission date. If
needed, questions and answers and/or clarifications of the announcement will be posted
as supplemental information regarding this proposal under the” Funding 2015” tab at the
JHU C POCT STD website: http://hopkinsmedicine.org/medicine/std.
The JHU C POCT STD encourages and considers it the responsibility of intended
applicants to review solicitation site for any updates to this announcement prior to
submission deadlines. All efforts will be made to provide information in a timely manner
prior to the submission deadline. The review dates and dates for informing applicants of
the outcome of their proposals are estimated and may be extended as needed.
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