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ReadyDetect FAQs

If we have a field-based LAMP (likely a chemistry assay, not antigen), would it be eligible?

This competition is specifically for antigen test development. Only antigen-based detection technologies are eligible. If you’re working on other pathogen diagnostic or lab-based technologies (e.g., LAMP, PCR, other molecular tests), please refer to other DRIVE-supported solicitations. 

Can you define “very low” cost of goods?

The desired product specifications list a cost of materials/goods under $0.50 per antigen test and under $10 for any associated (optional) reader. These are threshold targets. Applicants should provide a cost-of-goods calculation supported by vendor quotes, based on sourcing and manufacturing 100,000 units. While full-scale manufacturing isn’t expected, please include reasonable assumptions and substantiation. 

Does the product need to be FDA approved, or just have a clear path to approval?

FDA approval is not required at the prototype stage, as that would necessitate clinical trials. However, regulatory approval of the antigen test should be the ultimate goal of future development work. Devices intended solely for research use may not align with the competition’s focus on commercialization. 

What is the expected Technology Readiness Level (TRL) to apply?

No specific TRL is required. We encourage innovation at any stage. Applicants should provide strong scientific justification and any available preliminary data in their concept-stage submission. 

Will feedback be provided between stages?

No. To ensure fairness, feedback from the concept stage will not be provided before the prototype stage, as some prototype participants may not have competed in the concept stage. 

Would a molecular diagnostic using antibody-based lateral flow capture qualify?

No. This competition does not cover molecular diagnostics as they typically detect pathogen nucleic acid products. Please review other DRIVE- or BARDA-supported opportunities. This program focuses solely on (protein) antigen-based tests. 

I’m confused about the prototype stage—will the $3 million be awarded in Fall 2026 or Fall 2028?

The $3 million will be awarded to prototype-stage winners at the completion of the prototype project in Fall 2028. There are no upfront payments; funds are awarded to competition winners after evaluation of completed work. 

Does the prototype need to be a complete concept-to-result system?

The prototype should be a unified product that includes all components needed to deliver a result from sample input to readout. Readers or sample collection devices may be included, if necessary, but the focus is on the development and demonstration of the antigen test itself. Designs must be suitable for home and field use (i.e., CLIA-waived settings). 

Is antigen testing required, or will diagnostics using other methods that meet the desired product attributes be considered?

Antigen testing is a requirement. Only (protein) antigen-based diagnostic tests are eligible.

 

Regarding multiplexing—would different resistant strains of E. coli count as separate pathogens?

 It depends. Applicants must justify that the distinctions between the strains are clinically meaningful and relevant. The goal is to identify truly distinct pathogens. For example, distinguishing between Ebola virus subtypes would qualify. 

The threat list includes chemical agents like opioids. Does opioid detection qualify?

No. This competition is limited to infectious pathogen detection—not environmental or chemical detection. 

What scale should be used for cost-of-goods calculations?

Applicants should calculate COGs based on 100,000 units. The time period is flexible but must be justified logically in your submission. 

The $0.50 target seems unrealistic given sensitivity requirements. How strict is this requirement?

The cost targets are ambitious by design. This competition seeks innovative breakthroughs, not incremental improvements. All participants are evaluated under the same published criteria. 

Our technology meets all requirements except the $10 reader cost. Does that make us ineligible?

Not necessarily. You may still submit to the concept stage. The cost targets apply to winning submissions, but all are encouraged to apply and justify their assumptions. 

Is the first stage funded upfront, or only after selection?

No funds are provided upfront. The concept stage is self-funded. Winners, announced in Spring 2026, each receive $100,000. They may use this award to pursue the prototype stage. 

Does multiplexing refer to one test or multiple tests? Can two tests share the same reader?

Multiplexing refers to a single test run on a single sample to detect the presence of multiple distinct pathogens. Multiple separate tests do not count as multiplexed. 

Based on 100,000 units at $0.50, is that $50,000 in total commercial value?

Cost of goods (COGs) is not the same as price. A lower COGs provides greater flexibility for manufacturers to set pricing and maintain margins. 

When will concept-stage funding be awarded?

Concept-stage winners will be announced and awarded in Spring 2026. 

Do applicants need to participate in both stages of the prize competition?

No, the two stages are independent of one another. Applicants may apply to either stage or to both, depending on where they are in their development. 

Will Prototype Stage final submissions be evaluated on a rolling basis, or will the submission all be received and reviewed before any feedback is given?

Yes, winners of the prize competition will be selected as their final submissions are received. 

What details of the winning technologies will be disclosed publicly? I.e., to what extent will the winners remain confidential?

Non-confidential information will be disclosed publicly and will be reviewed by the finalists prior to publication; however, please expect that certain information will be made public. 

I still have questions? Who do I contact?

Schedule a 15-minute call with our Director of Innovation Programs.

Non-Dilutive Funding & Accelerator FAQs

Who's eligible?

Diagnostics and Medical Device platforms technologies aligned with BARDA’s mission to enhance pandemic preparedness and health security.

Foreign Owned Influence: the Awardee shall not have, and shall ensure that affiliates, Sub-awardees and DEV Project Sub-awardees do not have foreign investment capital/interests from USG prohibited sources list of embargoed and sanctioned countries, as defined by U.S. Departments of Treasury and Commerce.

What is I-CREATE looking for?

I-CREATE is seeking proposals for the development of innovative diagnostic and medical device innovations, in alignment with BARDA’s mission to promote health security. Innovators are invited to submit proposals for funding to allow:

  • Demonstration of proof-of-concept for a BARDA-relevant use case for an existing platform technology.
  • Demonstration of proof-of-concept for “high-risk” breakthrough technologies.
  • Advancement of technologies currently in development to the next value inflection point.
What technologies is I-CREATE looking for?
  • Diagnostics platforms detection, continuous monitoring, and triaging of infectious disease and biological threats.
  • High-sensitivity, high-specificity, low-cost at-home molecular diagnostics: innovative point-of-need diagnostic platforms for emerging infectious disease and biological threats.
  • Alternative, simple and user-friendly sampling and detection approaches (eg. breath)
  • Novel pathogen agnostic approaches to infectious disease and biological threats detection
  • Low-cost, deployable diagnostics for use in rural settings
What is the application and program timeline?

Submit your applications by September 30, 2025, to be considered for the 2026 cohort of I-CREATE.

Non-Dilutive Funding Track

November 2025 Full proposal submission

December 2025 Internview notification

January 2026 Finalists announced

Accelerator Program Track

November 2025 Interview notification

January 2026 Finalists announced

Are there any applicant resources?

Technology readiness level guidelines
Gantt template
Informational Webinar Recording - YouTube

What are BARDA’s mission priorities and specific target areas?

I-CREATE is seeking proposals for the development of innovative diagnostic and medical device innovations, in alignment with BARDA’s mission to promote health security. Innovators are invited to submit proposals for funding to allow:

  • Demonstration of proof-of-concept for a BARDA-relevant use case for an existing platform technology.
  • Demonstration of proof-of-concept for “high-risk” breakthrough technologies.
  • Advancement of technologies currently in development to the next value inflection point.
Where can I find information on BARDA’s other innovation hubs?
Visit https://drive.hhs.gov/accelerators.html for more information on all five innovation hubs.
How can applicants schedule office hours or calls with the program team?
Applicants can schedule office hours by clicking here.
Is there any advance payment available for the Non-Dilutive Funding Track before the first milestone is achieved? If yes, what percentage of the total award?
No,  Non-dilutive funds are disbursed upon completion of specified milestones.
Is the $200K award split among finalists, or can each finalist receive up to $200K?
Each finalist may receive up to $200k
Can a company participate in both the Accelerator and the Non-Dilutive Funding Track?
Applications may be submitted to both programs; however, priority will be given to companies participating in either the non-dilutive funding program or the accelerator, rather than those enrolled in both
If a company is already funded (e.g., NIH SBIR, angel investors), are they still eligible?
Funding may still be provided even when supported by other sources, provided that the funds are not used for the same purpose.
Does the Non-Dilutive Funding Track require travel to the U.S. for in-person events?
All funding and accelerator program activities are conducted virtually, and no travel will be required.
Given the 6-month project timeline, how many milestones are expected?
It depends on the project needs; most projects fall within two to four milestones.
Can the work be performed outside the U.S., or must it be carried out in U.S. labs?
Work conducted in the United States will be prioritized.
If a company applied in a previous round, can they apply again?
Yes, companies are eligible to reapply
Can I-CREATE support companies with overlapping technologies in the same or previous cohorts?
Yes, companies with overlapping technologies in the same or previous cohorts remain eligible for support.
Is preliminary data required for selection?
While preliminary data is not required, it is preferred that the technology be scientifically supported and demonstrate a basic proof of concept to be prioritized.
Are undergraduate students or early founders still pursuing degrees eligible to apply?
Yes
Would improved COVID tests (cheaper/faster) still be considered?
Yes, please check the PHEMCE website for the most up to date priority threats.
Are hospital point-of-care (POC) diagnostics eligible?
Yes
Do BARDA programs under the BAN favor university spinouts over independent startups?
The program does not give preference to university spinouts over independent startups.