Opportunity Information: Apply for RFA FD 17 002
This funding opportunity from the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA), focuses on improving Zika virus diagnostics by identifying short, highly specific Zika peptide sequences that can be used to build a more accurate IgM-based serology test. The work is framed by the public health urgency that emerged during the 2015-2016 Zika outbreak in the Americas, which led the World Health Organization (WHO) to declare a Public Health Emergency of International Concern in early 2016. Although WHO later ended that emergency designation, the announcement stressed that Zika and its consequences remain a long-term public health problem. In the United States, the HHS emergency declaration related to Zika was still in effect at the time of this announcement, underscoring the need for sustained diagnostic readiness.
The core problem the FDA is trying to solve is that existing diagnostic options have major limitations depending on when a patient is tested. Molecular tests such as RT-PCR are most useful during the brief period of viremia, since Zika virus typically circulates in blood for only about a week. After that window closes, viral RNA may no longer be detectable, including in cases where a newborn was infected in utero. That makes nucleic acid testing unreliable for many real-world diagnostic situations. Serology can fill that gap because IgM antibodies persist longer and can indicate recent infection, but current Zika IgM tests often produce false positives due to antibody cross-reactivity with other closely related flaviviruses such as dengue, West Nile, and yellow fever. Because of this, a positive Zika IgM result frequently requires confirmatory testing, adding time, complexity, and burden to public health and clinical decision-making.
To address this, the opportunity calls for a research plan that uses well-established methods with a high likelihood of success, supported by a team with demonstrated experience in the proposed technology. The recommended approach is peptide microarray (peptide chip) technology, where large sets of peptides are displayed on a solid surface (often glass or plastic) and probed with patient or reference sera to determine which peptides are bound by antibodies. This method is widely used to map antibody epitopes, profile immune responses over time, discover serologic biomarkers, and support diagnostic and vaccine development. In the Zika context, the aim is to create an epitope map across the Zika proteome to identify the most immunogenic and, most importantly, Zika-specific peptides. The announcement notes prior work in dengue showing that some conserved dengue peptides overlap with other viruses, while others do not, suggesting that uniquely Zika-specific targets should be discoverable with systematic screening.
A key deliverable is a set of differential peptide targets that can discriminate Zika IgM responses from responses generated by other common, cross-reactive arboviruses. The intended outcome is that these peptide targets could be incorporated into serological diagnostic assays that reduce or eliminate the need for burdensome confirmatory testing after an initial positive IgM result. From a regulatory and public health standpoint, the FDA highlights that the peptide information generated would be broadly shared, either via an FDA website posting or publication in peer-reviewed literature, so that companies, test developers, and public health institutions can use the findings to design, refine, or evaluate targeted diagnostic products. The broader value is improved medical countermeasure preparedness: being able to rapidly distinguish an emerging pathogen from a group of similar viruses that commonly confuse serologic testing.
The opportunity also emphasizes why better Zika diagnosis matters clinically, especially for pregnant women. Early and accurate identification of infection is tied to assessing risk for congenital outcomes such as microcephaly, a condition where an infant’s head is smaller than expected for age and sex and which can lead to lifelong disabilities and, in severe cases, life-threatening complications. The FDA positions the lack of highly specific Zika diagnostic tools as a critical readiness gap that hampers outbreak response and ongoing surveillance, particularly in areas where multiple arboviruses co-circulate.
In practical terms, the solicitation specifies sample expectations to ensure the peptide screening effort tests specificity against relevant confounders. It calls for approximately 10 Zika viral samples and recommends inclusion of potential co-infection or cross-reactivity comparators: 10 samples each for dengue virus types 1 through 4, yellow fever virus, West Nile virus, and chikungunya virus, plus two uninfected samples from collaborators. This panel is meant to help identify peptide targets that remain reliable even in the realistic clinical setting where patients may have prior exposure to related viruses or where multiple viruses circulate in the same region.
Administratively, the program is offered as a discretionary cooperative agreement under Funding Opportunity Number RFA-FD-17-002 (CFDA 93.103). The agency anticipated a single award, with an award ceiling of $299,150. The posting lists a creation date of March 31, 2017, and an original closing date of June 1, 2017, indicating it was a targeted, time-bound effort to quickly generate actionable peptide data for the diagnostic community.Apply for RFA FD 17 002
- The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Identification of Target Peptide Sequences for Zika IgM Diagnostic Device" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
- This funding opportunity was created on Mar 31, 2017.
- Applicants must submit their applications by Jun 01, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $299,150.00 in funding.
- The number of recipients for this funding is limited to 1 candidate(s).
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
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Frequently Asked Questions (FAQs)
What is the goal of this FDA funding opportunity?
The goal is to improve Zika virus diagnostics by identifying short, highly specific Zika peptide sequences that can be used to build a more accurate IgM-based serology test. The intent is to find peptide targets that are immunogenic (recognized by antibodies) and, critically, specific to Zika so they can help distinguish Zika infections from related viruses that commonly cause cross-reactive antibody responses.
Which agency is offering this opportunity?
This opportunity is offered by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number is RFA-FD-17-002.
What is the CFDA number listed for this program?
The CFDA number listed is 93.103.
What type of funding mechanism is being used?
The program is offered as a discretionary cooperative agreement.
How many awards did the agency anticipate making?
The agency anticipated a single award.
What is the maximum award amount (award ceiling)?
The award ceiling listed is $299,150.
When was the opportunity posted, and what was the closing date?
The posting lists a creation date of March 31, 2017, and an original closing date of June 1, 2017.
Why did the FDA identify Zika diagnostics as a public health priority?
The opportunity is framed by the public health urgency that emerged during the 2015-2016 Zika outbreak in the Americas, when the World Health Organization (WHO) declared a Public Health Emergency of International Concern in early 2016. Although WHO later ended the emergency designation, the announcement emphasizes that Zika and its consequences remain a long-term public health problem. In the U.S., the HHS emergency declaration related to Zika was still in effect at the time of the announcement, reinforcing the need for sustained diagnostic readiness.
What diagnostic limitation is this project trying to overcome?
The key limitation is that existing diagnostic options depend heavily on the timing of patient testing. Molecular tests (such as RT-PCR) are most useful during a short period of viremia, because Zika virus typically circulates in blood for only about a week. After that, viral RNA may no longer be detectable. This creates real-world gaps where nucleic acid testing can be unreliable, including situations like newborns infected in utero.
Why focus on IgM serology for Zika?
Serology can help after the viremia window closes because IgM antibodies persist longer and can indicate a recent infection. That makes IgM-based testing an important diagnostic approach when molecular detection is no longer reliable.
What problem do current Zika IgM tests commonly have?
Current Zika IgM tests often produce false positives due to antibody cross-reactivity with closely related flaviviruses, including dengue, West Nile, and yellow fever. Because of this, an initial positive Zika IgM result frequently requires confirmatory testing, which adds time, complexity, and burden for public health and clinical decision-making.
What is the proposed technical approach highlighted in the opportunity?
The recommended approach is peptide microarray (peptide chip) technology. Large sets of peptides are displayed on a solid surface (commonly glass or plastic) and probed with patient or reference sera to see which peptides are bound by antibodies. The project aims to create an epitope map across the Zika proteome to identify peptides that are both strongly immunogenic and highly Zika-specific.
How does peptide microarray technology support better Zika diagnostics?
By systematically screening many peptide sequences and measuring antibody binding, peptide microarrays can help identify differential peptide targets that discriminate Zika IgM responses from responses caused by other viruses. Those targets could then be incorporated into serology assays designed to reduce or eliminate the need for confirmatory testing following an initial positive IgM result.
What is meant by an "epitope map" in this context?
In this context, an epitope map is a detailed picture of which parts of the Zika proteome are recognized by antibodies in sera. Using peptide screening across the proteome helps identify the specific short sequences (peptides) most associated with Zika-specific antibody recognition.
Why is cross-reactivity with other viruses such a central concern?
In regions where multiple arboviruses co-circulate, patients may have prior exposure to related viruses or may be infected with a different virus that triggers antibodies capable of binding similar viral features. This cross-reactivity can confuse serologic testing and lead to false positives. The opportunity is explicitly designed to find peptide targets that remain reliable even with these confounders.
Which viruses are specifically mentioned as common sources of cross-reactive or confusing antibody responses?
The announcement specifically mentions dengue, West Nile, and yellow fever as closely related flaviviruses that can produce cross-reactive antibodies leading to false-positive Zika IgM results. Chikungunya is also included in the sample expectations as a comparator virus in the screening panel.
What deliverable is the FDA seeking from the funded project?
A key deliverable is a set of differential peptide targets that can discriminate Zika IgM responses from responses generated by other common, cross-reactive arboviruses. The practical aim is to provide peptide targets that can be used to improve serological diagnostic assays and reduce burdensome confirmatory testing.
How will the resulting peptide information be shared?
The FDA indicates that the peptide information generated would be broadly shared, either via an FDA website posting or through publication in peer-reviewed literature. The intent is for companies, test developers, and public health institutions to be able to use the findings to design, refine, or evaluate targeted diagnostic products.
Who is expected to benefit from the published peptide targets?
Companies, test developers, and public health institutions are explicitly identified as likely users of the shared peptide information. The broader diagnostic community is intended to benefit through improved readiness and better tools to distinguish Zika from similar viruses.
Why does the opportunity emphasize "well-established methods" and "high likelihood of success"?
The announcement calls for a research plan that uses well-established methods with a high likelihood of success and is supported by a team with demonstrated experience in the proposed technology. This reflects a practical, readiness-oriented goal: quickly generating actionable peptide data that can support improved diagnostics.
What sample panel does the solicitation expect or recommend for screening?
The solicitation calls for approximately 10 Zika viral samples. It also recommends including comparator samples to test specificity and rule out cross-reactivity: 10 samples each for dengue virus types 1 through 4, yellow fever virus, West Nile virus, and chikungunya virus, plus two uninfected samples from collaborators.
Why does the sample panel include multiple dengue virus types (1 through 4)?
Dengue virus has multiple types (1 through 4), and the solicitation explicitly recommends including 10 samples for each type. This supports specificity testing against a range of dengue-related antibody responses that could otherwise be mistaken for Zika in IgM-based assays.
What is the purpose of including uninfected samples?
The two uninfected samples from collaborators provide a baseline comparison to help interpret antibody binding patterns and support identification of peptide targets associated with infection rather than non-specific binding.
How is this work connected to improving confirmatory testing burdens?
The opportunity is designed to identify Zika-specific peptide targets that could be incorporated into serological assays. If an assay can more specifically identify Zika IgM responses, it can reduce or eliminate the need for additional confirmatory testing that is currently common after an initial positive IgM result.
How does this opportunity support medical countermeasure preparedness?
The broader value emphasized is improved preparedness: being able to rapidly distinguish an emerging pathogen from a group of similar viruses that commonly confuse serologic testing. The shared peptide targets are meant to enable faster development, refinement, and evaluation of diagnostic products.
Why is accurate Zika diagnosis especially important for pregnant women?
The opportunity highlights the clinical importance of early and accurate identification of infection for assessing risk for congenital outcomes, including microcephaly. Microcephaly is described as a condition where an infant's head is smaller than expected for age and sex and can lead to lifelong disabilities and, in severe cases, life-threatening complications.
What diagnostic scenario is mentioned where RT-PCR may fail even if infection occurred?
The announcement notes that after the brief period of viremia, viral RNA may no longer be detectable, including in cases where a newborn was infected in utero. This illustrates why nucleic acid testing can be unreliable for many real-world diagnostic situations.
What does the FDA identify as the critical readiness gap?
The FDA positions the lack of highly specific Zika diagnostic tools as a critical readiness gap that hampers outbreak response and ongoing surveillance, particularly in areas where multiple arboviruses co-circulate.
Does the opportunity specify where the peptide targets should be applied?
The intended outcome is that identified peptide targets could be incorporated into serological diagnostic assays (specifically IgM-based serology testing) to improve specificity and reduce false positives caused by cross-reactivity.
Is this opportunity focused on discovering biomarkers, mapping epitopes, or building a final commercial test?
Based on the description provided, the focus is on creating an epitope map and discovering differential peptide targets (serologic biomarkers) that can be used by others to design, refine, or evaluate diagnostic products. The opportunity emphasizes generating and sharing peptide information rather than describing development of a final commercial test as the primary deliverable.
What prior research example is used to support the idea that Zika-specific peptides can be found?
The announcement references prior work in dengue showing that some conserved dengue peptides overlap with other viruses while others do not. This is used to suggest that uniquely Zika-specific targets should be discoverable through systematic screening.
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|---|
| Food Safety Preventive Controls and Produce Safety Standards: Building Competency in Latin America in Support of the U.S. Food Safety Modernization Act Apply for RFA FD 17 011 Funding Number: RFA FD 17 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,100,000 |
| Creation and Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) Apply for RFA FD 18 002 Funding Number: RFA FD 18 002 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $30,000 |
| Global Pediatric Clinical Trials Network Apply for RFA FD 17 014 Funding Number: RFA FD 17 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,000,000 |
| Academic Development of a Training Program for Good Laboratory Practices in High Containment Environments (U24) Apply for RFA FD 17 013 Funding Number: RFA FD 17 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,500,000 |
| Building Research Capacity in Global Tobacco Product Regulation Program (U18) Apply for RFA FD 18 003 Funding Number: RFA FD 18 003 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $450,000 |
| Vet-LIRN Network Capacity-Building Projects Apply for PAR 18 604 Funding Number: PAR 18 604 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $225,000 |
| National Laboratory Curriculum Framework Development Apply for RFA FD 18 005 Funding Number: RFA FD 18 005 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Cooperative Agreement to Support the Western Center for Food Safety (U19) Apply for RFA FD 18 008 Funding Number: RFA FD 18 008 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $2,500,000 |
| Data Standards for Clinical Research and Drug Development (U24) Apply for RFA FD 18 015 Funding Number: RFA FD 18 015 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $750,000 |
| Bioequivalence of Topical Products: Elucidating the Thermodynamic and Functional Characteristics of Compositionally Different Topical Formulations (U01) Apply for RFA FD 18 010 Funding Number: RFA FD 18 010 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Formulation drug product quality attributes in dermal physiologically-based pharmacokinetic models for topical dermatological drug products and transdermal delivery systems (U01) Apply for RFA FD 18 019 Funding Number: RFA FD 18 019 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Three-Dimensional Approach for Modeling Nasal Mucociliary Clearance via Computational Fluid Dynamics (CFD) (U01) Apply for RFA FD 18 020 Funding Number: RFA FD 18 020 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $280,000 |
| Computational fluid dynamics (CFD) and discrete element modeling (DEM) approach for predictions of dry powder inhaler (DPI) drug delivery (U01) Apply for RFA FD 18 014 Funding Number: RFA FD 18 014 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $380,000 |
| Bioequivalence of Topical Products: Evaluating the Cutaneous Pharmacokinetics of Topical Drug Products Using Non-Invasive Techniques (U01) Apply for RFA FD 18 012 Funding Number: RFA FD 18 012 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Renewal Applications: Centers of Excellence in Regulatory Science and Innovation (U01) Apply for RFA FD 18 011 Funding Number: RFA FD 18 011 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $5,000,000 |
| Assuring Radiation Protection (U18) Apply for RFA FD 18 021 Funding Number: RFA FD 18 021 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $400,000 |
| Exploration of HL7 FHIR Standards for Clinical Research and Post-market Surveillance (U24) Apply for RFA FD 18 016 Funding Number: RFA FD 18 016 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $250,000 |
| Development of a virtual bioequivalence trial simulation platform that integrates population pharmacokinetic modeling algorithms into physiologically-based pharmacokinetic models (U01) Apply for RFD FD 18 018 Funding Number: RFD FD 18 018 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,800,000 |
| Cooperative Agreement to Support the Food and Agriculture Organization (FAO) (U01) Apply for RFA FD 18 009 Funding Number: RFA FD 18 009 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $1,000,000 |
| Cooperative Agreement to Support Regulatory Research Related to the 2018 Prescription Drug User Fee Act and the 21st Century Cures Act Apply for RFA FD 18 013 Funding Number: RFA FD 18 013 Agency: Department of Health and Human Services, Food and Drug Administration Category: Agriculture, Consumer Protection, Food and Nutrition Funding Amount: $4,200,000 |
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