Concept Stage
Advancing next-generation capillary blood collection and processing devices for diagnostics at the point of need — home, field, and resource-limited settings.
Prize per Winner
$
80000
Maximum Winners
0
June 15, 2026
Announcement
Competition Start Announced
TBD
Virtual Info Session (Option 2)
July 31, 2026
Submission due July 31, 2026
Submissions due to Vanguard
Fall 2026*
Prizes announced
Winner announced
No more than 5 winners will be announced for a $100,000 prize each.
June 15, 2026
Announcement
Competition Start Announced
TBD
Virtual Info Session (Option 2)
July 31, 2026
Submission due July 31, 2026
Submissions due to Vanguard
Fall 2026*
Prizes announced
Winner announced
No more than 5 winners will be announced for a $100,000 prize each.
*Specific dates will be announced when the Stage is launched.
The Concept Stage invites applicants to submit a concept paper (maximum 10 pages) summarizing their proposed innovation and plans for future prototype development and demonstration. It does not create an obligation to participate in the Prototype Stage or perform future experimental work.
Participation in the Concept Stage is optional and is not required for eligibility in the Prototype Stage.
Blood Sampling Competition: Concept Stage Overview
- The Concept Stage of the competition calls on all eligible entrants to submit concept papers of proposed work to be carried out during Prototype Stage detailing their respective technologies, proposed product, plans for development, and functional testing plans. The concept papers are expected to address key considerations for product development, regulatory review and approval, preclinical and clinical evaluation, and manufacturing processes to advance safe and effective blood sample self-collection and integration.
- The proposed devices must be functionally compatible with at least one antigen or molecular diagnostic test (ideally commercially available, FDA-approved/cleared test) and applicable to both adult and pediatric patients.
- Entrants can submit concept papers of no more than 10 pages.
- Submissions must describe the proposed product, including any supporting evidence (specifically, quantitative preliminary data) from the competitor’s development and evaluation efforts to date. Applicants may reference published peer-reviewed papers but are still required to include relevant data in the body of the submission.
- Entrants should discuss the experimental plan to achieve the end goal of the competition, which is the completion of a prototype with appropriate feasibility data by the end of the Prototype Stage. Feasibility data for the Blood Sampling Competition must include for the Concept Stage at least a plan for obtaining experimental evidence of functional compatibility with at least one test (ideally FDA-approved/cleared), including separating plasma and/or serum, according to the Indication for Use for the chosen test. (For the Prototype Stage, inclusion of such evidence is required.) Specific requirements are outlined in the table below and the Desired Product Attributes.
- Entrants must demonstrate as part of their submission that they have access to the required intellectual property for all components of the product and/or platform or a documented pathway to acquire that access.
- Entrants should discuss their commercialization plan and R&D capabilities, including ability to conduct work in, or partner with, BSL4 laboratories, as relevant.
- Submissions to the Blood Sampling Competition must include an ambitious but achievable Prototype Stage development plan, including:
- Plan for the prototype stage evaluation in terms of recruiting human subjects and (required) supporting IRB and clinical documentation
- Plan for demonstration of blood collection from human subjects (N≥75) from a representative and age-distributed population (pediatric and adult subjects) and safe transfer of sample with minimal or no sample loss to an antigen or molecular test
- Plan to maintain sample integrity, including for any extracted plasma and/or serum
- Approach to regulatory engagement, including analytical and clinical validation and submission timelines (Q-submission(s) and pre-market notification)
Desired Minimum Device and Test Performance Goals
The following outlines the desired minimum device and test performance goals.
Sample Collection Goals
Summary of desired minimum device/test performance goals
| Requirements | Sample collection |
|---|---|
| End user | Lay person/untrained personnel for self-collection of whole blood and immediate testing; healthcare worker or other adult administering the device to another patient – separate versions may be developed for adult and pediatric individuals, or a single version may be developed for both groups |
| Performance | Self-contained/integrated whole blood self-collection, while keeping the sample contained during transfer to a test device or cartridge to prevent accidental exposure |
| Functionality | The tool must incorporate a blood separation component to provide a sample (serum or plasma) compatible with an antigen and/or molecular test |
| Cost of goods | Ideally ≤ $1.00 at scale (including blood collection and integrated plasma / serum separation components) |
| Shelf life | At least 3 months (ideally up to 24 months) with large temperature and relative humidity ranges, and must not degrade in performance when exposed to direct sunlight for more than 1 hr |
| Results | The device and the final output (separated serum or plasma) must be functionally compatible with at least one antigen or molecular test (ideally FDA-approved/cleared) for detection of blood-borne pathogens in BARDA’s mission space (PHEMCE Priority Threats List). |
| Location | Clinical work and manufacturing will ideally be conducted in the United States |
Submissions should clearly indicate which sentences, if any, have been generated using artificial intelligence tools.
An expert judging panel will evaluate and score submissions according to Concept Stage evaluation criteria. Based on this evaluation, the judging panel will recommend up to 5 Concept Stage winners for the Blood Sampling Prize, each of whom will receive a $100,000 award from the $5 million Concept Stage prize pool.
Concept Stage Evaluation Factors
Product Design
- The extent to which the submission provides an innovative and credible approach to developing a product for the Blood Sampling Competition for clinical use, based on the requirements outlined in the Desired Product Attributes document
- The extent to which the submission demonstrates feasibility of the proposed product, including supporting evidence (i.e., quantitative data from your or collaborator’s lab; include TRL)
- The materials, or proposed materials, to be used to construct a future prototype along with information on proposed supplier(s)
- The feasibility of achieving threshold Desired Product Attributes
Regulatory and Commercialization Plan
- The extent to which the submission provides a realistic and sufficiently articulated plan to bring the product through FDA 510(k) approval/clearance and commercialization.
- Products intended to be manufactured in the United States are preferred
- The extent to which the submission demonstrates that the entrant has sufficient expertise and capabilities to usher the product through clinical validation and commercialization, including access to necessary intellectual property (evidence of IP ownership or licensing is required)
- The extent to which the submission identifies any additional capabilities that may be required and provides a clear approach to addressing those needs
- Envisioned impact of the proposed product on testing for conditions in BARDA’s threat space (see PHEMCE Priority Threats List)
At the end of the Concept Stage, winners will be announced formally in Fall 2026.
Have questions about ReadyDetect? View our FAQs, contact ReadyDetect@biotoolsinnovator.org, or schedule a 15-minute call with a member of the ReadyDetect team to discuss the competition, application requirements, and whether the opportunity may be a good fit for your technology.