ReadyDetect

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 1, 2026
Concept Stage Launched

The application window opens on June 1, 2026.

June 24, 2026
Virtual Webinar Option 1

Learn more about the opportunity and have your questions answered.

TBD
Virtual Webinar Option 2

Learn more about the opportunity and have your questions answered.

July 31, 2026
Concept Stage Applications Due

Applications are due by July 31, 2026.

Fall 2026*
Concept Stage Winners Announced

Up to 5 winners receive $100,000 each.

June 1, 2026
Concept Stage Launched

The application window opens on June 1, 2026.

June 24, 2026
Virtual Webinar Option 1

Learn more about the opportunity and have your questions answered.

TBD
Virtual Webinar Option 2

Learn more about the opportunity and have your questions answered.

July 31, 2026
Concept Stage Applications Due

Applications are due by July 31, 2026.

Fall 2026*
Concept Stage Winners Announced

Up to 5 winners receive $100,000 each.

June 1, 2026

Concept Stage Competition Launched

TBD

Virtual Webinar Option 1

TBD

Virtual Webinar Option 2

July 31, 2026

Concept Stage Applications Due

Fall 2026

Concept Stage Winners Announced

June 1, 2026
Concept Stage Competition Launched

The application window opens on June 1, 2026.

TBD
Virtual Webinar Option 1

Learn more about the opportunity and have your questions answered.

TBD
Virtual Webinar Option 2

Learn more about the opportunity and have your questions answered.

July 31, 2026
Concept Stage Applications Due

Applications are due by July 31, 2026.

Fall 2026
Concept Stage Winners Announced

Up to 5 winners receive $100,000 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.

Ready to compete?

Apply Today!

Required Submission Elements

Concept Stage submissions (maximum 10 pages) will capture the following information:

  • Product overview, including quantitative preliminary data and Technology Readiness Level (TRL) for each component of the solution
  • Indication for Use
  • Plan for compatibility with at least one BARDA-relevant antigen or molecular diagnostic test (preferably FDA-cleared) and applicable to both pediatric and adult populations
  • Approach for blood collection and processing, including plasma and/or serum separation consistent with the chosen test’s Indication for Use
  • Plan for generating feasibility data and advancing toward a functional prototype
  • Development plan for a prototype, including human subjects (N≥75), IRB pathway, and approach for safe sample transfer with minimal or no sample loss
  • Strategy to maintain sample integrity, including for any extracted plasma and/or serum
  • Regulatory strategy, including anticipated FDA engagement (e.g., Q-submission and pre-market pathway)
  • Intellectual property (IP) position or documented pathway to secure rights
  • Commercialization approach and R&D capabilities (including BSL-4 access, if applicable)
  • Materials and manufacturing considerations, including proposed materials and suppliers

Desired Minimum Device and Test Performance Goals

The following outlines the desired minimum device and test performance goals.

Sample Collection Goals
End User

  • Designed for lay persons / untrained personnel performing self-collection
  • Suitable for healthcare workers or adults administering to another patient
  • Separate or combined adult / pediatric versions acceptable

Performance

  • Self-contained / integrated whole blood self-collection
  • Sample fully contained during transfer to test device
  • Prevents accidental exposure throughout the workflow

Functionality

  • Must include an integrated blood separation component
  • Serum or plasma compatible with antigen and / or molecular test formats

Cost of Goods

  • Ideally ≤$1.00 at scale
  • Includes blood collection and integrated plasma / serum separation components

Shelf Life

  • Minimum shelf life 3 months (ideally up to 24 months)
  • Stable across large temperature and relative humidity ranges
  • Must not degrade after direct sunlight exposure >1 hour

Results

  • Device and final output (separated serum or plasma) must be functionally compatible with ≥1 antigen or molecular test
  • FDA-approved / cleared test compatibility strongly preferred
  • Targets PHEMCE Priority Threats blood-borne pathogens

Location

  • Clinical work ands manufacturing ideally conducted in the United States

Concept Stage Evaluation Criteria

A panel of experts will evaluate and score submissions according to the Concept Stage evaluation criteria below. Based on these evaluations, up to five (5) Concept Stage winners will be selected, each receiving a $100,000 prize.

Product Design

  • Extent to which submission provides an innovative and credible approach for clinical use, per Desired Product Attributes (DPA)
  • Extent to which submission demonstrates feasibility of the proposed product, including supporting quantitative data and TRL
  • Materials/proposed materials for prototype construction and proposed supplier(s)
  • Feasibility of achieving threshold Desired Product Attributes (DPA)

Regulatory & Commercialization Plan

  • Realistic and articulated plan to bring product through FDA 510(k) approval/clearance and commercialization
  • Products intended to be manufactured in the United States are preferred
  • Demonstrated expertise and capabilities for clinical validation and commercialization, including demonstrated IP access
  • Identification of any additional required capabilities and clear approach to addressing those needs
  • Envisioned impact of the proposed product on testing for conditions in BARDA's threat space (PHEMCE Priority Threats List)

Apply Today!

For additional information and questions, view our FAQs or contact ReadyDetect@biotoolsinnovator.org.

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