The Ready Detect: Next-Generation Diagnostics Competition is a $10 million, 2-part competition to advance high-performance testing and expand low-cost diagnostics into the home or in the field. I-CREATE, in partnership with the Biomedical Advanced Research and Development Authority (BARDA), calls on diagnostics researchers and developers worldwide to partner and accelerate the development of high-performance antigen tests that can be applied to the detection of key pathogens on PHEMCE’s high priority threats list.
Apply NowIn a public health emergency, access to reliable central testing can be limited – we need high-performance (high sensitivity and high specificity) multiplexed tests that are cost-effective to manufacture and easy to use both in the comfort of one’s home and in remote areas. Lateral flow assays (LFA) are cost-effective but often lack the sensitivity to compare with gold-standard PCR testing.
We need to enhance our diagnostic capability via a suite of multiplexed diagnostic devices and assays for key biological threats with a very low cost of goods that are usable in any CLIA-waived setting (including at home or in the field). These diagnostics must provide test sensitivity and overall accuracy that is on par with existing FDA-cleared NAAT (nucleic acid amplification) diagnostic tests while being compact, user-friendly, and environmentally stable across a wide range of temperature and humidity levels.
As healthcare moves towards decentralized settings – the urgent care or doctor’s office, pharmacy, or even one’s home – and people are taking greater agency of their health, it is imperative to provide access to at-home as well as remote testing capabilities for pandemic response and public health readiness. This is particularly true during periods of heightened disease threats, such as pandemic influenza, emerging infectious diseases, and priority biothreat (e.g., filovirus) outbreaks. The same tools and technologies used at home can also be applied in fully remote settings, which is critical for potential future outbreaks of emerging pathogens.
Our goal is to support innovations in a high-sensitivity, high-specificity, and very low-cost multiplex antigen test for respiratory and blood-borne pathogen diagnostics as part of the competition.
The ReadyDetect competition is a unique funding mechanism to foster industry collaboration and support the advancement of antigen test diagnostic candidates toward the completion of a prototype, supported with compelling feasibility data for the targets at clinically relevant concentrations in the appropriate specimen type and matrix. By demonstrating high performance in a CLIA-waived setting at a very low cost of goods, the competition will accelerate breakthroughs in diagnostics for respiratory and blood-borne pathogens. This moment presents a unique opportunity for diagnostics developers to advance innovative approaches to better protect the nation against future outbreaks.
The ReadyDetect competition will foster collaboration between commercial/for profit and non-profit competitors and provide resources to support the first effective demonstrations of high-performance, very low-cost CLIA-waivable diagnostic tests through prototype development and feasibility testing (demonstrating clinically relevant sensitivity of diagnostic target in the relevant clinical matrix).
Open to commercial, academic, and non-profit entities. Since the competition supports the ultimate goal of commercialization for the winning submissions, academic and non-profit competitors must partner with a commercial entity and provide evidence of such partnership (at minimum, via a letter of intent) to be eligible.
The Concept Stage of the competition calls on all eligible entrants – namely diagnostic test and instrument developers engaging in strategic partnerships – to submit concept papers 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, manufacturing processes to advance improved antigen diagnostic tests and instruments. The proposed devices must be multiplexed and include at least two pathogens from the list of key biological threats in BARDA’s mission space, which includes seasonal influenza, pandemic influenza A/HPAI H5N1, and filovirus, among others For example, tests detecting filoviruses should provide at a minimum detect and differentiate between Ebola virus (e.g., Sudan, Zaire, and Bundibugyo virus) or Marburg virus.
Entrants can submit concept papers of no more than 10 pages.
Submissions must describe the proposed product, including any supporting evidence from the applicant’s development and evaluation efforts to date. Submissions for the Antigen Product Prize competition must also describe the choice of at least two distinct pathogens from the list of BARDA’s priority pathogens.
Entrants should discuss the experimental plan to achieve the end goal of the Prize, which is the completion of a prototype with appropriate feasibility data. Feasibility data for the Antigen Product Prize must include data for the target pathogens at clinically relevant concentrations in the appropriate specimen type and matrix. If live pathogen target is not attainable, inactivated pathogen target may be considered as an alternative. Specific requirements are outlined in the TPP.
Applicants 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.
Applicants should discuss their commercialization plan and R&D capabilities, including ability to conduct work in or partner with BSL4 laboratories.
Submissions must include an ambitious but achievable development plan. Entrants for the Antigen Product Prize are required to define their pathogen diagnostic technology and criteria for success, with a brief rationale behind the criteria for success for each target. Submissions must to include a detailed approach to required preclinical and clinical activities, including:
Draft Intended Use/Indications for Use statement including proposed detected pathogens (specifying with or without type/strain differentiation), expected sample type(s) and clinical use setting(s) (i.e., CLIA-waived/professional use, non-prescription home use/OTC and/or lab-based).
Plan for the prototype stage in terms of obtaining and use of clinical samples (please note that spiked/contrived clinical samples are acceptable) and supporting clinical and IRB documentation.
Feasibility study plans with at least N=50 representative samples in relevant clinical matrix and analytical studies including, LOD, inclusivity, exclusivity, repeatability/reproducibility, and stability (e.g., minimum of 3-month real-time stability and accelerated stability over varied humidity and temperature conditions).
Clinical trial design synopsis and an overall plan for advancing the proposed product through completion of all required clinical and analytical studies that demonstrates safety and effectiveness/substantial equivalence according to FDA and CLIA-waiver guidance for 510(k) clearance/ de novo marketing authorization.
Approach to regulatory engagement, including analytical and clinical validation and submission timelines (Q-submission(s) and pre-market notification) and necessary fundraising/budget.
An expert judging panel will evaluate and score submissions according to Concept Stage evaluation factors. Based on this evaluation, the judging panel will recommend up to 10 Concept Stage winners for the Antigen Product Prize, each of whom will receive a $100,000 award from the $1M million Concept Stage prize pool at the end of the Concept Stage competition.
The degree to which the submission provides an innovative and credible approach to developing a product for clinical use, based on the requirements outlined in the TPP(s).
The degree to which the submission demonstrates feasibility of the proposed product, including supporting evidence.
Plan to meet minimum TPP requirements.
Regulatory and Commercialization Plan
The degree to which the submission provides a realistic and sufficiently articulated plan to bring the product through FDA pre-market notification process (510(k) clearance/de novo marketing authorization) and commercialization.
Products intended to be manufactured in the United States are preferred.
The extent to which the submission demonstrates the entrant and identified partner(s) have sufficient expertise and capabilities to usher the product through a clinical validation and commercialization, including access to necessary intellectual property.
The degree to which the submission identifies any additional capabilities that may be required and provides a clear approach to addressing those needs.
To be eligible to participate in the Prototype Stage competition, potential entrants to the Prototype Stage must submit a letter of intent to I-CREATE and provide all relevant regulatory documentation, including a clinical collection protocol and IRB documentation, prior to kickoff of the Prototype Stage. Selected entrants will be notified of acceptance by I-CREATE to enter the competition officially. Potential entrants must obtain I-CREATE's approval for the clinical protocol for their proposal to be eligible for participation in the competition. Entrants to the Antigen Product Prize competition may use clinical samples spiked with killed/inactivated virus in lieu of live virus and provide appropriate documentation of ethical sample collection by entrant’s IRB (or applicable vendor’s IRB) approvals. Virus can be sourced individually, but all entrants must provide Certification of Analysis (COA) documentation to BARDA for each pathogen.
To be eligible for a Prototype Stage Antigen Product Prize competition, entrants must furnish up to a 25-page report by the end of the (estimated) 12-18-month project and provide experimental evidence of the following success metrics, supported by a complete set of deidentified experimental data as an attachment:
For each chosen pathogen on a multiplexed test, provide experimental data demonstrating test performance has been met based on comparison to chosen gold standard as outlined in Concept Stage goals.
Provide photographic and/or video evidence of a prototype test and, if applicable, a reader in use.
Provide a detailed Cost of Goods calculation assuming manufacturing scale of 100,000 tests or devices. Numbers should be supported by submitted quotations as a report attachment.
Test performance (LoD, sensitivity, specificity, CV%) for each pathogen in clinically relevant concentrations in representative clinical matrix
Evidence prototype meets minimum TPP requirements
Multiplexing capability
Cost of Goods based on new technology rather than scale-up
Speed to completion and submission of comprehensive technical report
Entrants are not required to compete in the Concept Stage to be eligible to enter the Prototype Stage of the Prize competition.
Eligible submissions will be evaluated in the order in which they are received. An expert judging panel will assess submissions according to prototype evaluation factors listed above. The judging panel will recommend the first submissions that meet the evaluation criteria for Prototype Stage awards. Up to 3 submissions for the Antigen Product Prize can each receive a $3M Prototype Stage award at the end of the competition.
All winners are expected to be announced by Spring 2028.
Prototype Stage details are subject to change. Any changes will be announced prior to the launch/kickoff of Prototype Stage.
