Notice

The National Institutes of Health (NIH) has just issued a revised Federal Register Notice (FRN) for its Antimicrobial Resistance (AMR) Diagnostic Challenge.

Some of the updates to the original FRN include:

  • Clarification to the due date for the Letter of Intent
  • Clarification of the information that is to be included in the submission for Step 2
  • Additional details regarding the evaluation criteria and technical review process, as well as requirements related to human subjects and inclusion of women, minorities, and children.

The amended FRN can be found here. No deadline dates for the submission for Step 2 or Step 3 were changed. The revised Letter of Intent will be posted shortly.

 

Antimicrobial Resistance Diagnostic Challenge selects 10 semifinalists in first phase of competition
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Can you help create a diagnostic tool for health care providers to better identify resistant bacterial infections?

$20 million in prize awards

The main purpose of the Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test’ Challenge is to incentivize the development of one or more rapid, point-of-care in vitro diagnostic tests that would be of significant clinical and public health utility to combat the development and spread of antibiotic resistant bacteria or diagnostic tests that distinguish between bacterial and viral infections. The 18 specific drug-resistant bacteria are identified in Table 3 of the National Action Plan for Combating Antibiotic-Resistant Bacteria [1].

[1] https://www.whitehouse.gov/sites/default/files/docs/national_action_plan_for_combating_antibotic-resistant_bacteria.pdf, Table 3, p. 60.

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Challenge Description

Through the “Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test” Challenge (the “Challenge”), the National Institutes of Health (NIH) and the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR) are searching for novel and innovative in vitro diagnostic tests that would rapidly inform clinical treatment decisions and be of potential 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. The Challenge competition seeks to incentivize a broad range of scientists, engineers, and innovators to develop diagnostic tests that would enable healthcare providers to make more informed decisions on appropriate antibiotic use and infection prevention.

This Challenge, structured in three steps, will complement existing BARDA and NIH research portfolios by reaching out to a diverse population of innovators and solvers, including not only those from academic institutions, but also those from research and development communities in the private sector and others who are outside biomedical disciplines. 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.

AMOUNT OF THE PRIZE:

Step 1:  Up to $50,000 per semi-finalist (maximum of 20 semi-finalists)

Step 2:  Up to $100,000 per semi-finalist (maximum of 10 semi-finalists)

Step 3:  Equal to or greater than $18,000,000 to be divided among a maximum of three 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.

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).

REGISTRATION AND SUBMISSION PROCESS FOR SOLVERS:

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

SUPPLEMENTARY INFORMATION:

Statutory Authority to Conduct the Challenge: This Challenge is consistent with and advances the mission of the Department of Health and Human Services (HHS) to identify and support research that represents important areas of emerging scientific opportunities, rising public health challenges, or knowledge gaps that deserve special emphasis. The NIH and BARDA are conducting this competition under the America COMPETES Reauthorization Act of 2010 (Public Law 111-358), codified at 15 U.S.C.  3719.

Subject of Challenge:  On September 18, 2014, the President issued Executive Order 13676 on Combating Antibiotic-Resistant Bacteria, and announced the Administration would hold the Antimicrobial Resistance Challenge, as described in the accompanying White House Fact Sheet.  The development and use of rapid, point-of-need, and innovative diagnostic tests for identification and characterization of resistant bacteria was a goal identified in the National Strategy for Combating Antibiotic-Resistant Bacteria released in September 2014 and addressed in the National Action Plan for Combating Antibiotic-Resistant Bacteria released in March 2015.

In conformance with the above plans and directives, the NIH and the BARDA are sponsoring a Challenge competition, with the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) contributing technical and regulatory expertise to develop the award evaluation process.[1]

There are two clinical scenarios in which a diagnostic test is expected to have a significant impact on antibiotic stewardship:

  • Outpatient setting. Outpatient settings include physician offices, clinics, urgent care centers, and emergency rooms, as these offer healthcare services without hospital admission. These settings are often the first point of contact between patients and providers and play an increasingly important role in the delivery of healthcare services. Providers in this setting often need to make decisions on the use of antibiotics based on immediately observable information. Therefore, the ability to rapidly determine if a patient needs antibiotic therapy, and which antibiotic would be efficacious to treat the infection using clinically relevant samples, is of primary importance.
  • Inpatient Inpatient settings include hospitals and other settings in which patients are admitted for more than 24 hours. Patients admitted with serious infections such as sepsis and pneumonia require prompt bacterial detection, identification, and susceptibility for selecting appropriate antibiotic treatment. The ability to differentiate among many bacterial strains using many different sample types is critical. Additionally, hospital-acquired infections are a major concern in these settings, and the ability to determine if patients are infected with drug-resistant microorganisms is critical for both treatment and infection control.

Currently available in vitro diagnostics have not sufficiently addressed the needs in each of these settings. Therefore, a diagnostic that could advance the state-of-the-art in a reliable, cost-effective way would provide the healthcare community a significant advantage in combating antibiotic resistance. An additional benefit of an in vitro diagnostic would be to facilitate clinical trials for new antibacterial products by allowing enrollment of patient populations with specific infections, thus advancing the development of new antibacterial agents.

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.

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.

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. 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

(3) Detect biomarkers that would inform patient management decisions such as need for antibiotics or severity of infection.

[1] The NIH has engaged Capital Consulting Corporation to manage certain administrative aspects of this challenge, such as registration, as described below, under 15 U.S.C. § 3719(l).

Challenge Timeline

Step 1:

The Step 1 submission process was completed and semifinalists were selected on March 27, 2017.

Step 2:

Submission period begins: March 28, 2017
Letter of Intent due: August 3, 2018, 11:59 pm ET
Submission period ends: September 4, 2018, 11:59 pm ET
Judging period: September 5, 2018 – November 30, 2018
Up to 10 semi-finalists announced: December 3, 2018

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. All Step 2 Solvers must submit an updated letter of intent.  Please note that the amended Federal Register clarified that the prototype in vitro diagnostic device is not to be provided with the submission.

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.

Step 3:

Submission period begins: December 4, 2018
Submission period ends: January 3, 2020, 11:59 pm ET
Judging period: May 1, 2020 – July 1, 2020
Winner(s) announced: July 31, 2020

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 Registernotice no later than January 3, 2017. Administrative aspects of this Challenge will be managed by Capital Consulting Corporation.

FOR FURTHER INFORMATION, CONTACT

Robert W. Eisinger, Ph.D., NIH, 301-496-2229 or by email at robert.eisinger@nih.gov.

Challenge Requirements

ELIGIBILITY RULES FOR THE CHALLENGE:

  1. To Participate. This Challenge 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. All submissions for Step 1, 2, and 3 must be in English.

Eligibility to participate in Step 2 of the Challenge is not dependent on participation in Step 1 of the Challenge and being selected as a “Step 1 semi-finalist.” If a “Solver” did not participate in Step 1, he/she must follow the requirements listed in the “EligibilityTo Win” section of this announcement in order to submit a solution at Step 2. Step 1 semi-finalists are any individual, team, and/or entity whose solution received a meritorious rating based on the judging criteria. Eligibility to participate in Step 3 of the challenge is conditioned upon participation in Step 2 of the Challenge and being selected as a “Step 2 semi-finalist.”

  1. Eligibility to Win. To be eligible to win a prize under this Challenge, the Solver —
  • Shall have registered to participate in the Challenge under the rules promulgated by the NIH as provided on this website.
  • Shall submit a Letter of Intent, outlining the proposed in vitro diagnostic assay/assay system and its intended use.
  • Shall have complied with all the requirements set forth herein.
  • 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.
  • A Solver may not be a federal employee of HHS (or any component of HHS) acting in their personal capacity.
  • An individual, team, or entity that is currently on the Excluded Parties List will not be selected as a Semi-finalist or prize winner.
  • In the case of an entity, may not be a federal entity; and in the case of an individual, may not be a federal employee acting within the scope of his or her employment.
  • Federal employees otherwise permitted to participate in the Challenge shall not work on their submission during assigned duty hours. Note: Federal ethical conduct rules may restrict or prohibit federal employees from engaging in certain outside activities, so any federal employee not excluded under the prior paragraph seeking to participate in this Challenge outside the scope of employment should consult his/her agency’s ethics official prior to developing a submission.
  • HHS employees may not work on their applications or submissions during assigned duty hours. Commissioned Corps officers are excluded from this competition since they are on active duty at all times.
  • 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 entities are not eligible to compete in a prize competition.
  • 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.
  • 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.
  • 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.

All questions regarding the Challenge should be directed to Dr. Robert Eisinger, at robert.eisinger@nih.gov, and answers will be posted and updated as necessary at the website of the Challenge administered for NIH by Capital Consulting Corporation at http://www.cccinnovationcenter.com/challenges/antimicrobial-resistance-diagnostic-challenge/  under “Frequently Asked Questions.” Questions from Solvers that may reveal proprietary information related to solutions under development may be addressed in the Capital Consulting Corporation project room, an online secure and confidential communication form.

[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.

Submission Requirements

The Challenge has three steps and specific submissions for each step.

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

The Step 1 Submission has been completed.

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.

At a minimum, the Step 2 Submission shall include:

  1. The letter of intent must be submitted by August 3, 2018, at 11:59 p.m. ET, for all “Solvers” planning to submit for the Step 2 (Delivery of Prototype and Analytical Data) stage of the competition.
  2. The prototype in vitro diagnostic device is not to be provided with the submission. The September 8, 2016, announcement incorrectly stated that the device was to be included as part of the submission for Step 2.
  3. The Technical Evaluation Panel will use the following 4 criteria for evaluating the Step 2 submissions including: (a) Innovation; (b) clinical significance; (c) diagnostic performance and feasibility; and (d) sample matrix/setting and ease of use/throughput.
  4. A description sufficiently detailed and organized by sections for evaluation in the technical review and programmatic assessment of the proposed solution in 15 pages or less including the next 6 bullets, 8.5 x 11 inch page, 10-point or greater Arial, Palatino Linotype, or Georgia font and one inch margins including:
    • A title of the proposed solution;
    • A detailed description of the proposed in vitro diagnostic, and the development approach, challenges, and risks;
    • One section addressing each of the 4 criteria listed above;
    • One section providing a summary of the data, using the in vitro diagnostic device and the Standard Operating Procedures described in Appendix B, generated with either clinical or contrived samples compared to existing standard techniques demonstrating the performance characteristics (g., limits of detection, sensitivity, specificity, and other characteristics that demonstrate test performance to support detection of biomarkers or analytes). The September 8, 2016, announcement incorrectly stated that diagnostic performance characteristics included positive predictive value and negative predictive value;
    • Photographs of the in vitro diagnostic prototype device and a video not to exceed 5 minutes (in accordance with the NIH interim policy for submitting a video as NIH application materials https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-12-141.html) demonstrating the status of the development and actual use of the device in testing contrived or clinical specimens;
    • Address the NIH Human Subjects Protections and Inclusion of Women, Children, and Minorities policies, as well as biohazards policies (https://grants.nih.gov/​grants/​guide/​notice-files/​NOT-OD-15-078.html), if applicable.
  5. An Appendix A, provide additional data and tables to support the data summary and performance claims based on the use of the proposed solution testing clinical or contrived samples in 15 pages or less.
  6. An Appendix B with the standard operating procedures for the use of the solution submitted for Step 2 of the Challenge competition must be limited to 10 pages or less in length. If a longer Appendix is submitted, only the first 10 pages will be considered by the Technical Evaluation Panel and the Judging Panel.
  7. Submissions for Step 2 of the Challenge competition can be submitted to http://www.cccinnovationcenter.com/​challenges/​antimicrobial-resistance-diagnostic-challenge/​ beginning June 1, 2018. Submissions received after the deadline of September 4, 2018, at 11:59 p.m. ET will be disqualified and not evaluated by the Technical Evaluation Panel or Judging Panel.
  8. Solvers may submit corrections or additional materials in support of their Step 2 submissions so long as the NIH receives the materials by the deadline of September 4, 2018, at 11:59 p.m. ET. Corrections or additional materials for Step 2 will not be accepted or evaluated by the Technical Evaluation Panel or Judging Panel if they are received after September 4, 2018, at 11:59 p.m. ET.

 

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.

Evaluation Process

BASIS UPON WHICH WINNERS WILL BE EVALUATED

The NIH will perform an initial review of all submissions to ensure they are complete and within the scope of the Challenge competition. Submissions that are incomplete will be administratively disqualified and will not be evaluated by the Technical Evaluation Panel or the Judging Panel.

The NIH and Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority may determine that based on the number of submissions received for Step 2 that less competitive submissions will not be discussed by the Technical Evaluation Panel during the Panel’s meeting.

Solutions for all steps of the Challenge will be evaluated by a Technical Evaluation Panel using the criteria and rating scales describe below. Additionally, the BARDA scientific staff and the NIH scientific staff from the various NIH Institutes and Centers (ICs), including the Division of Program Coordination, Planning, and Strategic Initiatives (DPCPSI) of the NIH Office of the Director, will review highly rated solutions for scientific alignment with the National Action Plan for Combating Antibiotic Resistant Bacteria goal for a rapid, point-of-need diagnostic test that has the ability or potential to improve clinical decision making such that antibiotic use and/or outcomes of patients infected with drug-resistant pathogens are fundamentally improved compared to current standard of care and/or reduce transmission of drug-resistant pathogens. Specific examples could include allowing health care providers to: (1) rapidly identify/detect one or more 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 or (2) detect biomarkers that would inform patient management decisions, such as need for antibiotics or severity of infection.

The Judging Panel will determine which of the diagnostic test solutions are of relevance to the BARDA’s and NIH’s missions, and the degree of innovation advancing existing clinical diagnostics.  Three judges, comprising senior leadership from the BARDA and the NIH, will use the technical and programmatic evaluations to determine the Step 1 semi-finalists, those Solvers in Step 1 who are deemed meritorious; the Step 2 semifinalists, those Solvers in Step 2 who are deemed meritorious; and the Step 3 prize winner(s). Prizes will be approved by the Secretary, Department of Health and Human Services.

Step 1 (Theoretical) – Step 1 has been completed.

Step 2 (Delivery of Prototype and Analytical Data) – Step 2 submissions must provide a clear description of how experiments were conducted (including use of appropriate controls, instrument calibration, etc.), how the data were collected, and how analytical performance was assessed. Step 2 submissions must include all requisite scientific and technical details including materials, methods, protocols, and devices to demonstrate successful execution of the proposed solution. Has test reproducibility been demonstrated? What improvements and/or innovations were implemented above and beyond what was proposed in Step 1?

The Technical Evaluation Panel will use the following 4 criteria for evaluating the Step 2 submissions including: (a) Innovation; (b) clinical significance; (c) diagnostic performance and feasibility; and (d) sample matrix/setting and ease of use/throughput.

  1. Must be clearly novel and innovative technology representing an advance beyond the current state-of-the-science.
  2. Clinical significance. Clinical significance of the diagnostic use and likelihood that implementation would contribute to decreasing antibiotic resistance.
  3. Diagnostic performance and feasibility. The performance characteristics (e.g., sensitivity, specificity) required of the proposed in vitro diagnostic test in order for it to have significant utility in combating antibiotic resistance. It will also be important to demonstrate the likelihood, based on scientific concept, existing data, technological capability, and resources that the proposal can be successful at the end of Step 3 of this competition.
  4. Sample Matrix/Setting and Ease of Use/Throughput. The development of an effective in vitro diagnostic test that uses human samples (e.g., blood, urine, sputum, tissue fluid, multiple or other sample specimens).The settings or venues in which the proposed point-of-need in vitro diagnostic test may be most needed for combating antibiotic resistance. The development of an effective in vitro diagnostic test that is easy to use in either an inpatient and/or outpatient setting.  The proposed solution should require limited, if any, specimen processing. Test complexity, as assessed by applicability for over-the-counter, outpatient (i.e., CLIA-waived), or hospital-based settings (i.e., moderately complex CLIA laboratories) will be considered. Recognizing that diagnostics often require specialized equipment for sample storage, processing and/or analysis, considerations about how such specialized equipment may affect an in vitro diagnostic test’s ease of use or otherwise limit its utility.

Step 3 (Performance testing) – Step 3 submitters must provide the diagnostic device(s), any ancillary devices, procedure for using the device and interpreting the results, and controls for testing.  Specimen panels will be provided by the Challenge sponsors.

The Technical Evaluation Panel will use the following criteria and rating scales for evaluating proposed Step 3 solutions, with high scores reflecting the mostly highly rated solutions:

  1. Must be clearly novel and innovative technology representing an advance beyond the current state-of-the-science.
  2. Likelihood of improving the use of antibiotics in patients.
  3. Diagnostic performance. The performance characteristics (e.g., sensitivity, specificity, positive predictive value, and negative predictive value) of the in vitro diagnostic test using the prototype and likely impact of the performance on utility in combating antibiotic resistance.
  4. Sample matrix. The development of an effective in vitro diagnostic test that uses human samples (e.g., blood, urine, sputum, tissue fluid, multiple or other sample specimens).
  5. Time to test result. The development of an effective in vitro diagnostic test that rapidly produces results. Specifically, what would be the maximum acceptable time-to-result for an in vitro diagnostic test to be of significant utility (i.e., from the time that a sample is collected from a patient to the time that the result is available to the healthcare provider).
  6. Setting and ease of use. The settings or venues in which the proposed point-of-need in vitro diagnostic test may be most needed for combating antibiotic resistance. The development of an effective in vitro diagnostic test that is easy to use. Recognizing that diagnostics often require specialized equipment for sample storage, processing and/or analysis, considerations about how such specialized equipment may affect an in vitro diagnostic test’s ease of use or otherwise limit its utility.
  7. As part of the evaluation process, the panel may request a demonstration of the technology.

ADDITIONAL REQUIREMENTS:

Each individual (whether participating singly or in a group) or entity agrees to follow all applicable federal, state, and local laws, regulations, and policies.

Each individual (whether participating singly or in a group) or entity participating in this Challenge must comply with all terms and conditions of these rules, and participation in this Challenge constitutes each such participant’s full and unconditional agreement to abide by these rules.  Winning is contingent upon fulfilling all requirements herein.

Intellectual Property:  By submitting the Submission, each Solver warrants that he or she is the sole author and owner of any copyrightable works that the Submission comprises, that the works are wholly original with the Solver (or is an improved version of an existing work that the Solver has sufficient rights to use and improve), and that the Submission does not infringe any copyright or any other rights of any third party of which Solver is aware.

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.

Liability and Indemnification:  By participating in this Challenge, each Solver agrees to assume any and all risks and waive claims against the federal government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from participation in this Challenge, whether the injury, death, damage, or loss arises through negligence or otherwise. By participating in this Challenge, each Solver agrees to indemnify the federal government against third party claims for damages arising from or related to Challenge activities.

Insurance:  Based on the subject matter of the Challenge, the type of work that it will possibly require, as well as an analysis of the likelihood of any claims for death, bodily injury, or property damage, or loss potentially resulting from competition participation, Solvers are not required to obtain liability insurance or demonstrate financial responsibility in order to participate in this Challenge.

Privacy, Data Security, Ethics, and Compliance:  Solvers are required to identify and address privacy and security issues in their proposed projects and describe specific solutions for meeting them. In addition to complying with appropriate policies, procedures, and protections for data that ensures all privacy requirements and institutional policies are met, use of data should not allow the identification of the individual from whom the data was collected.

Solvers are responsible for compliance with all applicable federal, state, local, and institutional laws, regulations, and policies. These may include, but are not limited to, Health Information Portability and Accountability Act (HIPAA) protections, Department of Health and Human Services (HHS) Protection of Human Subjects regulations, and Food and Drug Administration (FDA) regulations. If approvals (e.g., from an Institutional Review Board) will be required to initiate project activities in Step 2, it is recommended that Solvers apply for approval at or before the Step 1 submission deadline of January 9, 2017, at 11:59 p.m. ET.

CHALLENGE JUDGES

Senior leadership of the DPCPSI of the Office of the Director of NIH; the National Institute of Allergy and Infectious Diseases (NIAID), NIH; and BARDA, ASPR.

ACKNOWLEDGMENTS:

The Antimicrobial Resistance Diagnostic Working Group would like to thank the following Subject Matter Experts for providing guidance as BARDA and NIH staff developed this Challenge.

NIAID staff including Ann Eakin, Ph.D. and Randall Kincaid, Ph.D.

FDA staff including Steven Gitterman, M.D., Ph.D. and Jennifer Ross, Ph.D., J.D.

CDC staff including Jean Patel, Ph.D., D (ABMM)

Representations and Warranties/Indemnification

By participating in the Challenge, each entrant represents, warrants, and covenants as follows: (a) entrant is the sole author, creator, and owner of the Submission; (b) the Submission is not the subject of any actual or threatened litigation or claim; (c) the Submission does not and will not violate or infringe upon the intellectual property rights, privacy rights, publicity rights, or other legal rights of any third party; (d) the Submission does not and will not contain any harmful computer code (sometimes referred to as “malware,” “viruses” or “worms”); and (e) the Submission, and entrants use of the Submission, does not and will not violate any applicable laws or regulations, including, without limitation, applicable export control laws and regulations of the U.S. and other jurisdictions.  If the Submission includes any third party works (such as third party content or open source code), entrant must be able to provide, upon Sponsor and/or Administrator’s request, all appropriate licenses and releases for such third party works.  In the event entrant cannot provide all required licenses and releases, Sponsor reserves the right, in Sponsor’s sole discretion, to disqualify the applicable Submission, or seek to secure the licenses and releases for Sponsor’s benefit and allow the applicable Submission to remain in the Challenge.  Entrants will indemnify, defend, and hold harmless Sponsor and Administrator from and against all third party claims, actions, or proceedings of any kind and from any and all damages, liabilities, costs, and expenses relating to or arising from entrant’s Submission or any breach or alleged breach of any of the representations, warranties, and covenants of entrant hereunder.  Sponsor and/or Administrator reserves the right to disqualify any Submission that Sponsor and/or Administrator, in its sole discretion, deems to violate these Official Rules.

Submission License

Each entrant retains title and full ownership in and to their Submission.  Entrant expressly reserves all intellectual property rights not expressly granted under this Agreement.  By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty free, worldwide, license and right to reproduce, publicly perform, publicly display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publicly display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.

Publicity Release

By participating in the Challenge, in addition to any other grants granted herein or which may be granted in any other agreement entered into between Sponsor and/or Administrator, on the one hand, and any entrant in the Challenge, on the other hand, each entrant hereby irrevocably (a) grants to Sponsor and Administrator the right to use such entrant’s name, likeness, image, and biographical information in any and all media for any purpose, including, without limitation, advertising and promotional purposes relating to the Challenge and (b) releases Sponsor and Administrator from any liability with respect thereto.

U.S. Government Support, Rights, and Waiver

Sponsor and Administrator are administering the Challenge with the support of the U.S. Department of Health and Human Services pursuant to the American COMPETES Reauthorization Act (the “Act“).  Subsection (j) of section 24 of the Act establishes that the Government is prohibited from acquiring an interest in intellectual property developed by a participant in a prize competition, such as the Challenge, without the written consent of the participant.  Registered participants shall be required to agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a competition, whether the injury, death, damage, or loss arises through negligence or otherwise. Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the head of the Office of the National Coordinator for Health Information Technology, for claims by (a) a third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered participant’s insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and (b) the Federal Government for damage or loss to Government property resulting from such an activity.