Evaluation criteria

Clinical development

The degree to which the submission shows progress towards clinical performance study design, planning and execution.

Performance

The degree to which the submission demonstrates the potential performance of the solution against minimum and ideal performance across target product characteristics.

Applied development

The degree to which the submission shows progress toward functional development of the solution into a practical testing device or platform, including the extent to which stakeholder needs have informed development.

Scalability

The degree to which the submission outlines a clear plan for product design, including process and controls development to enable scale manufacturing.

Planning

The degree to which the submission outlines a clear plan for delivery of a complete regulatory submission and preliminary strategy for diagnostic commercialization toward marketing a real-world product.

Clinical validation

The degree to which the clinical performance study has been executed and has produced rigorous data to support premarket regulatory submission.

Performance

The degree to which the submission demonstrates the performance of the product against minimum and ideal performance across target product characteristics.

Applied development

The degree to which the submission shows progress toward functional development of the proposed solution into a practical testing device or platform, including the extent to which stakeholder needs have informed development.

Scalability

The degree to which the submission outlines a clear plan for product design, including a sound approach to manufacturing at scale and development of distribution channels for equitable access.

Planning

The degree to which the submission outlines a clear commercial strategy, including a realistic business model and well-defined go-to-market plan for the diagnostic product.

Diagnostic sensitivity

Diagnostic tests should correctly detect a Lyme disease infection where needs are unmet by current FDA-cleared tests. Diagnostic tests should seek positive agreement with clinically diagnosed and/or well-characterized positives. Tests should demonstrate a positive percent agreement above 50% across intended use cases, or sensitivity levels to Lyme disease infection in intended use cases sufficient to demonstrate substantial patient benefit greater than current practice.

Diagnostic specificity

Diagnostic tests should correctly detect the absence of a Lyme disease infection. Diagnostic tests should seek negative agreement with well-characterized (uninfected) negatives. Tests should demonstrate a negative percent agreement above 90%.

Analytical specificity

Diagnostic tests should not report a positive result for Lyme disease infection due to cross-reactivity from lookalike conditions or adverse effects of common interfering substances. Tests should demonstrate the absence of cross-reactivity and interference.

Acceptability

Diagnostic tests should require a sample collection process that minimizes patient burden, and can be easily performed by trained health personnel. Tests should not require a sample collection method more complex or invasive than a venous blood draw.

Result reporting

Diagnostic tests should provide a result that enables trained health personnel to make clinical decisions. Tests should provide a qualitative report that describes a positive or negative result with an underlying quantitative readout.

Diagnostic setting

Diagnostic tests should be designed for broad availability. Testing devices and processes should be able to be scalably deployed in CLIA-certified laboratories, and should be able to be performed by laboratory personnel.

Performance

The degree to which the entrant demonstrates that a solution can or will accurately diagnose an active Lyme disease infection. This includes the credibility of explanation and the level of expected performance with regard to specificity and sensitivity, with data to support.

Technical maturity

The degree to which the solution has been developed with a rigorous scientific rationale grounded in credible existing research, preliminary testing, or other relevant forms of validation. This includes demonstrating an understanding of Lyme disease diagnostics and offering a credible explanation for how the solution overcomes known technical challenges in the field.

Clinical impact

The potential for the solution to integrate into new or existing clinical protocols and maintain performance across a range of patient populations. This includes a well-developed plan to engage clinical and patient stakeholders.

Population impact

The potential for the solution to improve population health, including its proposed or demonstrated accessibility, the extent to which entrants address equity in the design and implementation plans, and the opportunity for public health impact through improved data and surveillance.

Viability

The extent to which the entrant outlines an aggressive yet achievable development process, including a detailed development plan for prototyping, iteration, testing/validation, and evaluation of the diagnostic test(s) in future phases of the Competition and/or beyond, including a consideration of potential risks or unintended consequences.

Sustainability

The degree to which the entrant demonstrates scalability potential and provides a credible long-term plan for regulatory viability, market entry, business need, and the development of the test as a real-world product.

Innovation

The novelty and uniqueness of the solution, as well as its potential to advance the field of Lyme disease diagnostics and treatment as a whole, including opportunities to advance scientific understanding of Lyme disease spirochetes through contributions to the existing evidence base.

Performance

The degree to which the entrant has improved and/or further verified the proposed solution’s diagnostic performance (for example, sensitivity and specificity), which represents a meaningful improvement over currently available approaches.

Technical maturity

The degree to which the submission reflects a more rigorous and credible understanding of scientific mechanisms (for example, biological, chemical, and physical) underlying the proposed diagnostic approach, and addresses how the approach will be consistently replicated in real-world settings.

Clinical impact

The degree to which the submission further details a clear and credible understanding of how the proposed diagnostic will integrate into new or existing clinical protocols, and how the diagnostic has been optimized for a range of clinical settings and patient populations.

Population impact

The extent to which the entrant has engaged patients in design and development and demonstrably advanced the expected accessibility, equity, and public health impact of the proposed solution.

Viability

The extent to which the entrant has progressed against its plan for prototyping, iteration, testing, validation, and evaluation of its diagnostic test(s); refined and further detailed its ongoing plan; and enhanced its understanding of risks and risk mitigation.

Sustainability

The degree to which the entrant demonstrates scalability potential and provides a credible long-term plan for regulatory viability, market entry, business need, and development of the solution as a real-world product.

Innovation

The extent to which the entrant has shown meaningful learning through Phase 2 activities, including challenging its own assumptions and iterating based on results.