Non-Dilutive Funding Program
High interest focus areas include, but are not limited to:
- Advanced Assays and Reagents for omics, cell-based, and imaging applications to speed up medical countermeasure development
- Drug Candidate Identification Technologies (including in silico models) that can identify new or repurposed candidates that address health security threats
- AI-Based Tools/Algorithms and Automation to develop predictive analytics and/or model process parameters to expedite biopharmaceutical manufacturing of medical countermeasures
- Novel Sample Prep, Automation, or Miniaturization Tools to speed up development of medical countermeasures and biomanufacturing capabilities
- Analytical Platforms applicable to multiple Vaccines/Therapeutic Products with a focus on rapid Critical Quality Assurance analytical testing technologies for Drug Substances and Drug Products to harmonize release assays and potency assays
- Digital Twin Approaches using Multimodal Clinical Data, including AI (e.g., EHR, imaging, unstructured notes) to enable early identification, endotyping, or treatment guidance for disease severity to enable early intervention
- Integrated Bioprocess Optimization combined with modeling to establish control strategy and expedite manufacturing of medical countermeasures
- Novel Approaches for Generation of Polyclonal Recombinant Antibodies to treat infectious diseases
For more information on BARDA areas of interest, visit https://drive.hhs.gov/partner.html. You may also find BARDA’s strategic priorities by visiting the pages for each of BARDA’s medical countermeasure programs: https://medicalcountermeasures.gov/
BARDA also recently released TPPs relevant to some of its areas of interest: https://medicalcountermeasures.gov/barda/tpp.
We are accepting proposals from early-stage biotech companies as well as academic and other innovators globally.
We are accepting proposals from early-stage biotech companies as well as academic and other innovators globally. Companies and individuals are welcome to submit an application for the Accelerator Program and a proposal for non-dilutive (DEV) funding from BTI VANGUARD. Applications and proposals will be reviewed independently. Solicitations for both the Accelerator Program and non-dilutive (DEV) funding opportunities will be open on an annual basis.
No, SAM.gov registration is not required.
- Preliminary Proposal Deadline: September 30, 2025
- Invitation to Submit Full Proposal: By November 15, 2025
- Program Start: March 2026
Proposals will be evaluated with a particular focus on 1) the ability of the technology in the proposal to support BARDA’s mission, 2) the uniqueness of the innovation and its ability to address unmet needs, and 3) the capacity for the proposed use of funds to advance the technology to the next value inflection point.
It is anticipated that project milestones will be completed in 6 months from the start of the project, and that the funding will be spent during this time period. Project management and mentor support will be provided during this 6-month period. BTI VANGUARD and BARDA also understand that unforeseen and unpredicted events happen during development, evaluation and validation activities.
There will be reporting requirements on a monthly basis, upon milestone achievement, a mid-project meeting with BARDA, and a final report and presentation.
Allowable expenses for the non-dilutive funds from BTI VANGUARD include: direct costs for development, evaluation, or validation activities, and labor for personnel and subcontractors/CRO partners contributing to the milestone completion. We recommend that the budget is well-distributed across expense categories (e.g. not spending the full budget on a piece of equipment) and keeping personnel costs below 60%.
Companies and individuals that receive funding from BTI VANGUARD will have access to BARDA subject matter experts and other related BARDA resources. Access to these BARDA resources will be managed and coordinated by the BTI VANGUARD Team.
A technology that aligns to the BTI VANGUARD Hub might also be aligned to some of the other BAN Hubs, including Therapeutics/Vaccines and Diagnostics/Medical Devices. Organizations should also look into open Areas of Interest for the BARDA DRIVe EZ-BAA funding opportunity and other BARDA funding and partnership opportunities. The decision about which Hub or program to apply to is up to the organization.
- BARDA DRIVe: https://drive.hhs.gov/partner.html
- BARDA BAA funding: https://medicalcountermeasures.gov/barda/barda-baa/
- BARDA’s main page: www.medicalcountermeasures.gov
ReadyDetect: Blood Sampling Competition
General Overview
ReadyDetect is a $5 million prize competition focused on advancing next-generation blood sample collection and processing devices for use in decentralized settings, including the home, field, and resource-limited environments.
The prior competition was through another hub called ReadyDetect Antigen Prize competition, and that was meant to support the development of novel attitudes. This Blood Sampling Competition focuses on the blood sample collection and processing side, for use with a broad range of diagnostics within BARDA’s mission space.
BARDA has identified gaps in existing devices: they are not cost-effective enough for broad field deployment and often require extra manual transfer steps rather than integrating smoothly with diagnostic tests. This competition is seeking more cost-effective, more seamlessly integrated alternatives.
The competition consists of two stages:
- Stage I (Concept): Concept paper submission; up to five (5) winners, each receiving $100,000.
- Stage II (Prototype): Completion report & data submission detailing prototype development, testing, and validation; up to three (3) winners, each receiving $1,500,000.
No. The two stages are independent. Applicants may apply to either stage or both, depending on their level of development.
Eligibility & Teaming
U.S.-based commercial, academic, and non-profit organizations are eligible. Academic and non-profit entities must partner with a commercial entity and provide evidence of such partnership.
The focus of this specific competition is on the development of the device itself.. If there are companies in your network that provide local services related to this area, this could potentially be a good opportunity for them to explore.
Yes. The primary entrant must be a U.S.-based entity at the time of submission and through prize award.
Yes. Teams may include subcontractors, consultants, CROs, and partners. The primary entrant must lead the technical effort.
Yes, provided each submission represents a distinct technology or approach.
Collaboration intent is not an absolute requirement. Applicants should include partnerships when they strengthen feasibility, evaluation, development, manufacturing, regulatory strategy, or commercialization. Strong collaborations may be viewed positively as part of team strength and overall feasibility. Partnership is only required for non-commercial entities who will need to identify a relevant commercial entity in their application.
Concept Stage
Applicants must submit a concept paper (maximum 10 pages) describing their innovation, development plan for the prototype stage, including plans to recruit patients and functional compatibility demonstration with an antigen or molecular diagnostic test. This should include supporting evidence of the technology development and performance to date. Additional publications and supporting documents can be supplied as supplementary documentation.
Yes. Submissions must include quantitative preliminary data generated by the applicant and a Technology Readiness Level (TRL) assessment.
No specific TRL is required. Applicants at all stages are encouraged to apply, but must provide sufficient technical justification and supporting data.
No. The Concept Stage is focused on evaluation of proposed concepts, development plans, and future prototype strategies and does not fund execution of experimental or prototype development work. Up to five (5) winners will be selected after evaluation and each will receive a $100,000 prize.
No. The program is structured as a competition and will offer designated webinars to answer questions from potential applicants. To ensure fairness, feedback on submissions and technologies will not be provided between stages.
Yes. Applicants may present work from an existing prototype as part of a Concept Stage application. Having a prototype does not make an applicant ineligible.
No. The Concept Stage is a research strategy or proposal documented in a concept paper. No work on the device is planned for the Concept Stage of the competition. If applying to the Prototype stage, the Concept stage plan can be used as the research plan to be executed during that stage of the competition.
Applicants are required to provide existing preliminary data from their own team or collaborations on sample collection and separation performance. Applicants will also need to identify the diagnostic test for a relevant BARDA threat that they plan to demonstrate compatibility within later work. The requirement to run the diagnostic with the specific sample collection prototype device begins at the Prototype Stage.
Prototype Stage
Applicants must submit a letter of intent and required regulatory documentation, including a clinical collection protocol, informed consent forms, a federal-wide assurance (FWA) number, and IRB approval. Additionally, applicants must obtain written approval from the VANGUARD ReadyDetect team prior to officially entering the competition.
Prototype Stage prizes are awarded after completion of the prototype work and evaluation of final submissions. Prizes are expected to be awarded in the summer of 2028.
No. The Prototype Stage is not funded upfront. Up to three winners are selected after evaluation and each will receive a $1,500,000 prize.
No. All Prototype Stage submissions will be reviewed together following the submission deadline. The winners will be announced after all submissions have been evaluated.
No. Pathogen data is not required for the application. If accepted into the Prototype stage competition, applicants will need to demonstrate functional compatibility with a specified diagnostic.
Yes. Applicants may apply to the Concept Stage or Prototype Stage with an existing prototype device.
Technical Requirements
Devices that enable self- or caregiver-administered blood collection, support plasma and/or serum separation, and integrate with antigen or molecular diagnostic tests.
No. FDA approval is not required at the prototype stage. However, applicants should demonstrate a clear path toward regulatory approval and CLIA waiver as part of future development.
Yes. Devices must be functionally compatible with at least one antigen or molecular diagnostic test for a blood-borne pathogen on the PHEMCE Priority Threats List, preferably FDA-cleared.
Yes. Prototype Stage submissions must include data from at least 75 human subjects, including both pediatric and adult populations.
Yes. Applicants must provide a Cost of Goods (COGs) analysis at a 100,000-unit manufacturing scale, supported by vendor quotes.
Cost targets are intentionally ambitious to encourage breakthrough innovation. Applicants should provide well-supported assumptions and justification.
The program’s intent is field-deployable individual diagnostics, not centralized pooled testing.
The Desired Product Attributes (DPA) outline the threshold (essential) and optimal performance goals for ReadyDetect technologies, including usability, safety, cost, shelf life, sample handling, and diagnostic compatibility. These attributes are intended to guide development and will inform evaluation across both competition stages. Additionally, solutions should support adult self-administration and be appropriate for pediatric use, where an adult or healthcare worker may administer the device to a child. Applicants should address usability across all relevant age ranges.
The target applies to the device. It is a target (longer is better) rather than a fixed requirement, and current materials do not specify a shelf-life requirement for the collected sample itself.
The required volume depends on the diagnostic test selected by the applicant. Please review desired product attributes here. If a technology requires a different starting volume, applicants should explain and justify that approach in their submission.
No. For the Blood Sampling Competition, the focus is on the physical device for self-collected blood with integrated or compatible plasma or serum separation. The device should be functionally compatible with a test and may integrate a diagnostic test or be used with an external one. Applicants must select a diagnostic test relevant to BARDA and demonstrate functional compatibility in the Prototype stage, but the competition is not focused on developing the diagnostic test itself.
No. Applicants are not required to obtain infectious clinical samples or perform testing on actual infected blood, including for high-risk pathogens, at any stage of the competition. The requirement is to demonstrate functional compatibility: the sampling and separation device should provide the required sample volume, transfer appropriately, and allow the diagnostic test to run without error. High-containment collaborations may be included if they strengthen the development or evaluation plan, but they are not required at the Concept Stage or Prototype Stage of the competition.
Yes. The DPA lists an integrated safety lancet (or acceptable microneedle alternative) as an essential requirement. Therefore, a standalone blood collection device without an integrated lancet/microneedle is not acceptable. An integrated, streamlined design is required rather than merely preferred.
The Desired Product Attributes describe a self-contained, integrated device for whole blood self-collection that keeps the sample contained during transfer to help prevent accidental exposure to biohazardous material. The cost-of-goods target, ideally ≤$1.00 at scale, applies to the entire device, including blood collection and integrated plasma/serum separation components. These are desired attributes rather than absolute requirements. Applicants proposing reusable and disposable components should clearly explain how the system aligns with the competition goals, including usability, safety, cost, manufacturability, and commercialization.
Intellectual Property (IP) & Confidentiality
Entrants retain ownership of their IP. Applicants must demonstrate access to all IP required to develop and commercialize their solution.
Submissions will be reviewed by authorized evaluators and covered under nondisclosure agreements. Non-confidential information about selected winners may be publicly disclosed, following appropriate review.
Submission Process
Applications are submitted through the Innovator Portal, which will guide applicants through each required component.
Yes. Applications can be modified up to the submission deadline.
Late submissions will not be accepted.
Yes, but AI-generated content in submissions must be clearly identified at the sentence level (e.g., via footnotes).
Additional Questions
Yes. Virtual webinars will be held during both stages of the competition to provide additional information about ReadyDetect, review stage-specific requirements and expectations, and answer participant questions. Please refer to the timeline on the ReadyDetect webpage for webinar dates and registration links.
Please refer to the PHEMCE Priority Threats List.
For additional information, please contact: ReadyDetect@biotoolsinnovator.org.
Level UP-XR Program
Control groups may be real-time cohorts or utilize historical training data or retrospective benchmarks.
You are NOT required to have a partner at the onset. Applicants may apply individually during the preliminary proposal phase. Those without a pre-designated partner will be matched with possible synergistic partners. Selection of partners will need to be completed in order for the pairing to submit a full proposal.
For this pilot program, this is used to capture augmented reality (AR) and virtual reality (VR) platforms.
Each pair may propose a combined budget amount up to $300,000. The full proposal will outline who will receive the sub-award amounts and for what activities or reasons.
For additional information and questions, please contact vanguard@biotoolsinnovator.org.