FAQs on AMR Diagnostic Challenge

1) What is the purpose of this competition?

Response: In this Challenge, the NIH and the BARDA are seeking proposals for the development of new, innovative, accurate, and cost-effective in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria. Tests of interest will provide novel, innovative solutions for use in inpatient and/or outpatient settings. The goal of the challenge is to identify a diagnostic test that, when utilized, would lead to more rapid clinical decision making such that antibiotic use and/or outcomes of patients infected with resistant pathogens are fundamentally improved compared to current standard of care, and/or reduce transmission of resistant pathogens such that population infection rates significantly decrease.

2) Do I need to have an NIH or BARDA grant or contract in order to submit for this competition?

Response:  No. You do not need to have a current NIH or BARDA grant or contract in order to submit an entry. The Challenge competition seeks to incentivize a broad range of scientists, engineers, and innovators from academic institutions, research and development communities in the public and private sector, as well as others outside of biomedical disciplines, to develop in vitro diagnostic tests that would enable healthcare providers to make more informed decisions on appropriate antibiotic use and infection prevention. The NIH and the BARDA believe this Challenge will stimulate investment from both public and private sectors in rapid, point-of-need in vitro diagnostic assay research and product development, which, in turn, could lead to the development of more sensitive, accurate, robust, and cost-effective assay approaches and devices for clinical diagnosis.

3) Who is eligible to submit an entry for this competition?

Response: This Challenge competition is open to any “Solver” where “Solver” is defined as an individual, a group of individuals (i.e., a team), or an entity. Whether singly or as part of a group or entity, each individual participating in the Challenge must be 18 years of age or older. We welcome solutions from individuals, teams, and entities from all U.S. sources, including the public sector, private sector, and nonprofit groups.

In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States; and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States. Note:  Individuals who are non-U.S. citizens and nonpermanent residents may participate as a member of a team that otherwise satisfies the eligibility criteria, but will not be eligible to win a monetary prize (in whole or in part); however, their participation as part of a winning team, if applicable, may be recognized when results are announced. The team leader must be a U.S. citizen or U.S. resident.

An individual, team, or entity that is currently on the Excluded Parties List (https://www.epls.gov/) will not be selected as a Semi-finalist or prize winner.

To be eligible to win a prize under this Challenge, the Solver:

  • Shall have registered to participate in the Challenge:
  • Shall submit a letter of intent outlining the proposed in vitro diagnostic assay/assay system and its intended use.

An individual shall not be deemed ineligible to win because the individual used federal facilities or consulted with federal employees during the Challenge provided that such facilities and/or employees, as applicable, are made available on an equitable basis to all individuals and teams participating in the Challenge. In addition, members of the Technical Evaluation Panel are not eligible to participate in or contribute to any proposal for Step 2 and Step 3 of the Challenge competition.

4) Can a Federal employee submit an entry for this competition?

Response: A Solver may not be a federal employee of HHS (or any component of HHS) acting in their personal capacity. A Solver employed by a federal agency or entity other than HHS (or any component of HHS), should consult with an agency Ethics Official to determine whether the federal ethics rules will limit or prohibit the acceptance of a prize under this challenge.

5) If I am an NIH or BARDA grantee/contractor can I apply for this competition? Can I use the funds from my existing award to support the development of my entry for this competition?

Response:  If you are a current NIH and/or BARDA grantee or contractor, you are eligible to submit an entry. Federal grantees may compete, but may not use federal funds to develop America COMPETES Act challenge applications unless consistent with the purpose of their grant award.  If a grantee using federal funds wins the competition, the award needs to be treated as program income for purposes of the original grant in accordance with applicable Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards 1.

Federal contractors are eligible to participate, but may not use federal funds from a contract to develop submissions for an America COMPETES Act prize competition or to fund efforts in support of an America COMPETES Act prize competition. Costs associated with such activities are unallowable and are not allocable to government contracts.

 

1 2 CFR § 200, “Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards” supersedes OMB Circular A-21, Cost Principles for Educational Institutions, OMB Circular A-87, Cost Principles for State, Local, and Indian Tribe Governments, OMB Circular A-110, Uniform Administrative Requirements for Grants and Other Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations, and OMB Circular A-122, Cost Principles for Non-Profit Organizations.

6) Why is this competition lasting almost 5 years? Will a winner(s) be announced sooner than this timeframe?

The timeframe for this competition is designed to allow submitters sufficient time to develop their proposed entries from the theoretical/concept stage into a functional in vitro assay system that can be tested in two independent CLIA-certified laboratories. The NIH and the BARDA may shorten the submission period for Steps 2 and 3 and adjust dates for judging and winner(s) announcement if the Step 1 winners’ feasibility assessments suggest shorter Step 2 and 3 submission periods are possible.  The NIH and the BARDA will announce any changes to the timeline by amending this Federal Register notice no later than January 3, 2017.

7) What is a step down competition? How does this three-step competition work? What is required at each step of this competition?

A step down competition permits a progressive assessment of entries until a final winner(s) is/are selected. This Challenge competition has three steps (following registration and submission of a Letter of Intent), and specific submissions for each step.

The Challenge has three steps (following registration and submission of a Letter of Intent), and specific submissions for each step.

All submissions for Step 1, 2, and 3 must be in English.

Step 1 (Theoretical) – Step 1 of the Challenge requires a written proposal that describes a potentially clinically significant, new, innovative, and cost effective, point-of-need in vitro diagnostic test for use in either an inpatient or outpatient setting that could allow healthcare providers to significantly inform clinical treatment decisions and be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria.  For example:

  1. More rapidly identify/detect the specific etiology drawn from a differential diagnosis of a particular clinical syndrome caused by any of the 18 drug-resistant bacteria of highest concern which can be found in Table 3 of the National Action Plan for Combating Antibiotic Resistant Bacteria released in 2015;
  2. More rapidly identify/detect, and characterize antibiotic susceptibility of at least one of the 18 drug-resistant bacteria of highest concern which can be found in Table 3; and
  3. Detect biomarkers that would inform patient management decisions such as need for antibiotics or severity of infection.

The Step 1 Submission shall include:

  1. A description sufficiently detailed for evaluation of the proposed solution in 10 pages or less including the next four bullets, 8.5×11 inch page, 10-point or greater Arial, Palatino Linotype, or Georgia font and 1 inch margins including:
    • A one-paragraph executive summary that clearly states the clinically significant concern being addressed and the specific intended use of the proposed diagnostic device;
    • A description of the proposed in vitro diagnostic, and the development approach, challenges, and risks;
    • A “State-of-the-Art” statement that (1) describes approaches currently in use (if any); (2) clearly explains how the methods and measures proposed will outpace/outperform current advancements; (3) will provide a useful tool for rapid clinical decision making; and (4) provide potentially quantifiable improvements beyond existing capabilities;
    • A description of how Solvers plan to complete Step 2, including methods and technologies key to implementation. This should include estimated timeframe, supporting precedents, and a feasibility assessment and description of the Solver’s ability to execute the proposed solution, including any unique resource(s) that may be needed.  The “Solver” needs to address the NIH Human Subjects Protections and Inclusion of Women, Children, and Minorities policies in their submissions for Step 1 of this competition. Information on the Protections for Humans Subjects can be found here. The submission should also be in compliance with policies related to the use of Vertebrate Animals, biosafety issues, and use of methods/technologies covered by patents or other intellectual property protection, as applicable;
    • All Step 1 Submitters also will need to provide an Executive Summary for public posting on the AMR Diagnostic Test Challenge website. Proprietary information should not be included in the Executive Summary, since this will be accessible to the general public.
    • Optional Appendices describing existing, unpublished experimental data (if available) that support the proposed solution may be included. Please note that there is a 5-page limit on the appendices. All information that is confidential/proprietary should be so indicated.
  2. Any Appendix submitted for Step 1 of the Challenge competition must be limited to 5 pages or less in length. If a longer Appendix is submitted, only the first 5 pages will be considered by the Technical Evaluation Panel and the Judging Panel.

Step 2 (Delivery of Prototype and Analytical Data) – Any Solver is eligible for Step 2 of this Challenge competition. For example, if a Step 1 “Solver” is not identified as a semifinalist, he/she may still submit for Step 2 of this competition and those who did not submit a Step 1 proposal may still submit a proposal for Step 2.

However, if a Solver did not participate in Step 1, he/she must follow the requirements listed in the “Eligibility To Win” section of this announcement. Step 2 Solvers will develop the proposed diagnostic solution(s) of Step 1 of the Challenge and submit (in the Step 2 submission) a prototype device and data supporting the ability of the in vitro diagnostic device to meet the target product profile (TPP) for analytical and performance characteristics in non-clinical testing (i.e., contrived specimens, panels, etc.), as well as confirmation of analytical performance (e.g., limit of detection, interference, inclusivity, etc.)

Additional details on submission requirements for Step 2 of the Challenge will be available to Step 2 Solvers no later than 30 days after the Step 1 semi-finalists are announced.

At a minimum, the Step 2 Submission shall include:

  1. Execution: Description of the successful generation of a prototype diagnostic test(s) that is based on the Step 1 solution, which may also include innovations, essential alterations in the original proposed plan, and/or technical or analytical challenges experienced or anticipated. Any changes from the original design (Step 1 solution) should be documented and explained.
  2. Data: At a minimum, a summary of the analytical performance (limit of detection, inclusivity and exclusivity testing) demonstrated by non-clinical testing (i.e., contrived specimens or panels), and demonstrated progress or plans to achieving the target product profile.
  3. Detection of New Analyte/Biomarker: The Solvers should provide data to the judges that demonstrate the utility or potential utility of the test for clinical management. The extent and scope of these data are up to the Solver. The judges will assess the strength of these data in projecting the potential impact of the diagnostic test.

Step 3 (Performance testing in CLIA-Certified Laboratories) – All Step 2 semi-finalists will be eligible to participate in Step 3. Solvers in the third step of the Challenge will have their solutions (prototypes) evaluated in two independent CLIA-certified laboratories. The cost for the CLIA-certified laboratory testing will be incurred by the Challenge Sponsor, not the Solvers. This will permit an assessment of the performance of prototype in vitro diagnostics confirmed by independent testing. Step 3 Solvers will execute their proposed solution(s) to Step 2 of the Challenge and submit (in the Step 3 submission) sufficient numbers of their solutions (prototype platforms and diagnostic test kits/reagents) for testing. The testing in these two independent laboratories will ensure the solution(s) demonstrate usability, stated time to result, appropriate analytical sensitivity/specificity by non-clinical and/or clinical testing (i.e., contrived specimens or panels of drug resistant bacteria), as well as confirmation of analytical performance (e.g., limit of detection, interference, inclusivity, reproducibility, etc.) reported in the data submitted by solver in Step 2.

Additional details on submission requirements for Step 3 of the Challenge will be available to Step 3 Solvers no later than 30 days after the Step 2 semi-finalists are announced.

The Step 3 submission requires each semi-finalist to submit:

  1. Project Description: Detailed description of materials, methods, personnel, resources, and schedule. Any changes from the original design (Step 2 solution) should be documented and explained.
  2. Execution: The Solvers selected for Step 3 must provide two prototype instruments and sufficient numbers of the diagnostic test(s) based on the Step 2 solution for testing by the two CLIA-laboratories, as well as methodology/protocols to perform diagnostic testing using the prototypes.

8) How do I register and where do I submit my entry?

Response:  To register and submit for this Challenge, Solvers may access the registration and submission platform from any of the following:

Please note that you must submit your letter of intent by December 23, 2016.

9) Do I need to submit a grant application in order to be considered for this competition?

Response:  No. The submission of a grant application is not required to enter this competition.

10) Are there safeguards in place if my entry includes proprietary information?

Response:  Proprietary information should not be included in the Executive Summary required for Step 1 of this competition since this summary will be posted to the AMR Diagnostic Test Challenge website which is accessible to the general public. While a secure system is provided to protect proprietary information included in all materials submitted for this competition, it is the individual solver’s responsibility to determine if proprietary information should be included in his/her submission.

11) Is the prize in cash or does the winner get a NIH or BARDA grant or contract?

Response:  The winner(s) does/do not receive an NIH or BARDA grant or contract as a prize for this competition. The semi-finalists selected for Step 1 may receive up to $50,000 per semi-finalist (maximum of 20 semi-finalists).  For Step 2, up to $100,000 per semi-finalist (maximum of 10 semi-finalists) may be awarded.  For Step 3, equal to or greater than $18,000,000 may be divided among a maximum of 3 awardees based on the number of prizes awarded to Step 1 and 2 semi-finalists from a total pool of $20,000,000.

As determined by the judges, the number of prizes will be determined for the Step 1 and 2 semi-finalists and Step 3 winner(s) from a total pool of $20,000,000.

12) What happens if there are no winning entries?

Response:  The NIH and the BARDA reserve the right to cancel, suspend, and/or modify this Challenge at any time through amendment to the Federal Register notice. In addition, the NIH and the BARDA reserve the right to not award any prizes if no solutions are deemed worthy. The award approving official for Step 3 of this Challenge is the Secretary, Department of Health and Human Services (HHS).

13) What does it take to win the prize?

Response: The prize-winning in vitro diagnostic(s) must meet a set of predefined technical criteria and performance characteristics based on the intended use(s), as described further below.  Solutions submitted to this Challenge should have the potential to significantly improve clinical decision making compared to the current standard of care. Solutions also should be novel, innovative, rapid, and appropriate for use at the point-of-need. Ultimately the solution should be an in vitro diagnostic assay(s) that can:

  • improve antibiotic decision making by healthcare providers and be effective in reducing inappropriate use of antibiotics
  • demonstrate a clinically significant advance in diagnostic test performance and address gaps or deficiencies in current capabilities that may include, but are not limited to:
    • ease of use;
    • time to result;
    • significant advances in sensitivity and specificity; and
    • ability to process a broad range of specimen types.

Examples of breakthroughs in this arena could allow healthcare providers to:

  • more rapidly identify/detect the specific etiology drawn from a differential diagnosis of a particular clinical syndrome caused by any of the 18 drug resistant bacteria of highest concern, which can be found in Table 3 of the National Action Plan for Combating Antibiotic Resistant Bacteria released in 2015;
  • more rapidly identify/detect, and characterize antibiotic susceptibility of at least one of the 18 drug resistant bacteria of highest concern, which can be found in Table 3; and
  • detect biomarkers that would inform patient management decisions such as need for antibiotics or severity of infection.

14) What type of entry is ineligible to win the prize?

Response:  Solutions describing existing, well-established and/or currently supported approaches, especially commonly used strategies are not of interest unless a compelling case is made that potentially clinically significant, quantifiable advances are achievable and/or the methods and measures are used in unique combinations that have not been previously tested together for the detection/diagnosis of drug resistant bacteria.

The entry must comply with the deadlines and page requirements listed in the Challenge. It must be in English and include information regarding human research protections.

15) If I am not selected as a winner for Phase I, can I still compete for Phase 2?

Any Solver is eligible for Step 2 of this Challenge competition. For example, if a Step 1 “Solver” is not identified as a semifinalist, he/she may still submit for Step 2 of this competition and those who did not submit a Step 1 proposal may still submit a proposal for Step 2. Step 2 solvers will need to submit a Letter of Intent.

16) When does a submitter need to provide the U.S. Government with license to the technology described in the submission?

The submitter provides the license only if his/her submission is selected as a winner of the challenge competition.  As the Federal Register Notice states, “To receive an award, Solvers will not be required to transfer their exclusive intellectual property rights to the NIH or ASPR. Instead, Solvers must grant to the federal government a nonexclusive license to practice their solutions and use the materials that describe them. To participate in the Challenge, each Solver must warrant that there are no legal obstacles to providing a nonexclusive license of Solver’s rights to the federal government. This license must grant to the United States government a nonexclusive, nontransferable, irrevocable, paid-up license to practice or have practiced for or on behalf of the United States throughout the world any invention made by the Solvers that covers the Submission. In addition, the license must grant to the federal government and others acting on its behalf, a fully paid, nonexclusive, irrevocable, worldwide license in any copyrightable works that the Submission comprises, including the right to reproduce, prepare derivative works, distribute copies to the public, and perform publicly and display publicly said copyrightable works.

17) Can I enter Step 2, if I have not submitted a letter of intent nor a Step 1 proposal?

Yes you can. However, you will need to submit a Letter of Intent.

18) When does the government obtain a license under the license clause? Specifically, do NIH and BARDA obtain a license when they select the semi-finalist and/or winning Solver(s), or when the Cash Award is accepted by the semi-finalist and/or winning Solver(s), or at some other point?

As stated in the Federal Register Notice, “to receive an award… Solvers must grant to the federal government a nonexclusive license.”  This means that the Solver(s) will need to provide this license in a letter to the government that actually grants the license.  The Solver(s) would do this after the winners are selected and before, and as a condition of, actually receiving the cash award.

19) Does a solver need to send in a new letter of intent for Step 2 if they submitted one for Step 1?

Yes, all solvers for Step 2 must send in a LOI by August 3, 2018 at 11;59pm ET.

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