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NIH Technology Accelerator Challenge Non-invasive Diagnostics for Global Health
Develop diagnostic technologies for sickle cell disease, malaria, and anemia, and other high-impact diseases
Department of Health and Human Services - National Institutes of Health
Type of Challenge: Scientific
Partner Agencies | Federal: NIH Office of the Director, National Institute of Allergy and Infectious Disease, National Heart, Lung and Blood Institute, National Institute of Diabetes and Digestive and Kidney Diseases, and the Fogarty International Center
Partner Agencies | Non-federal: The Bill and Melinda Gates Foundation
Submission Start: 03/02/2020 10 a.m. ET
Submission End: 06/16/2020 5 p.m. ET
This challenge is externally hosted.
You can view the challenge details here: https://venturewell.org/ntac/
The National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health supports and encourages the development of new diagnostic technologies important for global health. Through this Challenge, NIBIB will offer $1,000,000 in prizes to reward and spur the development of platform concepts and prototypes of non-invasive, multiplexed diagnostic technologies for sickle cell disease, malaria, and anemia, diseases with high global and public health impact. The Bill & Melinda Gates Foundation shares a commitment to global health and is cooperating with NIBIB to consider additional support for the Challenge winners and honorable mentions. The Gates Foundation, separately, will review the Challenge winners and honorable mentions selected by NIBIB for potential follow-on funding of up to $500,000 and in-kind support that can transform design concepts into products for global health on an accelerated timeframe.
Five components of NIH have partnered with NIBIB to contribute to the $1,000,000 prize purse and will participate in selection of winners and honorable mentions: NIH Office of the Director; National Institute of Allergy and Infectious Disease; National Heart, Lung and Blood Institute; National Institute of Diabetes and Digestive and Kidney Diseases; and the Fogarty International Center.
- Register your intent: May 2, 2020
- Submissions open: March 2 - June 2, 2020
- Judging Start/End: June/July 2020
- NIBIB winners announced: August 2020
NIH will offer $1,000,000 in prizes, including up to $500,000 for a top finalist and smaller awards to approximately five semi-finalists. NIBIB may recognize additional participants with non-monetary honorable mentions.
Following the NIH selection of winners, the Gates Foundation has indicated its intent to separately consider and assess the submissions of the prize winners and honorable mentions for potential additional support from Gates Foundation to develop the proposed technologies for global health applications. If selected by Gates Foundation after the Challenge, follow-on support from Gates Foundation may include grants of up to $500,000 and in-kind support in the form of consultations and partnerships for clinical data collection, software development, scale-up and manufacturing. The goals of this collaborative effort are to stimulate the design of new diagnostic technologies to transform public and global health and to accelerate the full development of products for use in low-resource settings.
To be responsive to this Challenge, a submission should present two proposals:
- A design with initial feasibility data for a diagnostic platform assessing two diseases in the vasculature, one of which must be sickle cell disease, malaria, or anemia.
- A robust description of the path for translation of the technology to global health use cases, and how the technology will need to develop further to reduce cost and be suitable for field use.
A strong Challenge submission includes a device design with the following characteristics:
- Technical validity demonstrated by initial feasibility data or references
- Platform potential: potential to adapt or extend the device to at least two relevant diseases/conditions
- At least one target disease should be sickle cell disease, malaria, or anemia
- Measures parameters that could be used to track disease state and/or response to therapy
- Uses mobile device or portable attachment to a mobile device
- Non-invasive and does not require blood sampling
- Low-cost and accessible
- Self-contained and highly portable; for example, proposed device does not use biological reagents
- Allows rapid data collection and time to result
- Integrates prior context about the patient and environment into the test results
- Scalable to population delivery
Basis Upon Which a Winner Will be Selected
Participants will present a design and initial feasibility data or references for a non-invasive diagnostic platform to address 2 diseases in the vasculature (at least one of sickle cell, malaria, or anemia). The technology design must describe both the biological principle of the test and measurement approach. Participants may share data collected on prototypes (if available) and up to five pieces of evidence or feasibility data that de-risk elements of the test and the device. To ensure alignment with global health use cases, participants must also submit a robust proposal addressing following questions:
- What changes and further development for hardware, software, or data generation would be required to meet a global health use case?
- What are potential areas for cost reduction and technologies or approaches to achieve the target use case, considering the form factor and capital cost listed in the product requirements below?
The following describe the judging criteria for evaluating submissions for (1) feasibility data demonstrating the utility of the technology across two diseases, and (2) proposals for the utility of the device in global health contexts.
Note: Where appropriate, partial credit may be available against these criteria.
Approach and performance criteria, for evaluation of feasibility data:
- Platform approach. Proposed device must have a path to use the same underlying technology to address at least two diseases in the vasculature. One disease must be sickle cell, malaria, and / or anemia. Proposals will only be accepted if they describe a way to extend to two diseases on a single platform. Full points require in vivo target accuracy in representative background populations for two diseases, though scoring will be scaled appropriately.
- Analytic performance. Proposed device must be relevant for clinical decision-making, with results that are comparable to or improve upon standard practice at a peripheral care setting. The device must have comparable analytic sensitivity and specificity to existing tests. The device should be able to incorporate dynamic personal and population priors (e.g. medical history or disease prevalence, respectively) to improve the accuracy of the test result in clinical settings.
- For anemia, in comparison to the reference method, 85% of the results must fall within +1.0g Hb/dL of the reference across a range of Hb concentrations spanning the healthy range and moderate to severe anemia.
- Clinical utility. Device must be able to differentiate between relevant strains of the disease, across necessary population age brackets, and over the course of disease progression.
- For sickle cell, the device needs to differentiate sickle cell as early in life as possible, in conjunction with dynamic priors. Ideally, the device should be able to perform with high levels of fetal hemoglobin still present and should be able to differentiate sickle cell disease from sickle cell trait.
- For malaria, the device needs to be able to detect and differentiate various parasite species. Required are Plasmodium falciparum (Pf) and / or Plasmodium vivax (Pv); Optimal is all Plasmodium species. If all species cannot be differentiated, differentiation between Pf and Pv is desired.
- An anemia diagnostic must clinically differentiate mild, moderate and severe anemia. In addition, it must have 95% sensitivity and 90% specificity in each trimester of pregnancy at the moderate anemia threshold of 11.0g/dL and the severe anemia threshold point of 7.0g/dL.
- Detection and interpretation. Proposed device should measure parameters that could be used to track disease state and/or response to therapy. Results from a test must be interpretable by a machine.
- Safety. If used, light sources should be Class 2 or Class 3R with appropriate controls to avoid eye exposure or skin damage. Devices must not trigger crises or significant occlusion events in sickle cell patients. Intended use, for evaluation of feasibility data (where possible) and use case proposal:
- Time to results. Results should be interpretable within 15 minutes.
- Data capture. Information should be captured digitally from the device in <10 seconds if handheld, and <60 seconds if wearable. Data should be transferrable to a data system subsequently.
- Components. The platform should be either (1) a standalone mobile device or (2) an algorithm on or small attachment to a mobile phone. Proposals should discuss potential for miniaturization of a prototype to this end state.
- Form factor. The device should be self-contained and highly portable. For example, the devices should not require biological reagents, and a health worker should be able to carry it independently over varied terrain. The participants can determine the appropriate form factor for the intended use case.
- Cost. The final cost of the device should be <$500, not including the cost of the phone. Proposals should discuss the potential for cost-reduction to meet this target cost.
- Target use case. The device should be intended for use in zero infrastructure conditions including outdoor settings and performed by untrained lay persons.
- Lifespan of device. The final device should last at least two years. Proposal should discuss potential to achieve a two-year lifespan.
- Ease of use. The device should have no user-timed steps; five or fewer user steps, instructions should include diagram of method and results interpretation
How To Enter
Register and submit on the Challenge website. Be sure to review the Challenge Guidelines.
Although a notice of intent to submit an application is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows NIH staff to estimate the potential review workload and plan the review. By May 2, 2020, prospective applicants are asked to indicate on the challenge websiteChallenge website</a> in the Challenge Applicant Portal the participant or team's intent to submit an application. This is done by selecting "Intent to Submit an Application" after providing the following information in the Challenge Applicant Portal:
- Descriptive title of proposed activity
- Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
- Names of other key personnel
- Participating institution(s) or entities