Antimicrobial Resistance Diagnostic Challenge
The Antimicrobial Resistance Diagnostic Challenge is a $20 million federal prize competition seeking innovative, rapid point-of-care laboratory diagnostic tests to combat the development and spread of drug resistant bacteria. A rising public health problem, antibiotic resistant bacteria cause at least 2 million infections and 23,000 deaths each year in the United States, according to the Centers for Disease Control and Prevention (CDC). The Challenge calls for new, innovative, and novel laboratory diagnostic tests that identify and characterize antibiotic resistant bacteria and/or distinguish between viral and bacterial infections to reduce unnecessary uses of antibiotics, a major cause of antibiotic resistance. With real-time detection, healthcare providers would be able to identify infecting pathogens and resistance factors within hours, rather than days, and use the knowledge to tailor treatment to each individual.
The Challenge is a joint effort between the National Institutes of Health and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) in support of the National Action Plan for Combating Antibiotic Resistant Bacteria. NIH’s National Institute of Allergy and Infectious Diseases (NIAID) and ASPR’s Biomedical Advanced Research and Development Authority (BARDA) are each contributing $10 million to the Challenge. The Challenge also was developed with technical and regulatory expertise from the CDC, Food and Drug Administration, and NIH Office of the Director.
For more information about the challenge or how to apply, please visit the challenge website.
October 3, 2016
Notice of Correction for Announcement of Requirements and Registration for "Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test" Challenge (NOT-OD-17-004)
September 8, 2016
Federal prize competition seeks innovative ideas to combat antimicrobial resistance
Announcement of Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge Competition (NOT-OD-16-137)
Step One: Initial Concepts Submitted and Semifinalists Selected
From all submitted concepts, 10 semifinalists were selected, each receiving $50,000 to develop prototypes and analytical data for their diagnostic devices. More information about the concept submissions can be found here
Deadline for Letter of Intent: December 23, 2016
Deadline for submissions: January 9, 2017
Semifinalist selected: March 27, 2017
Step Two: Finalists Selected
Ten finalists will be selected to receive up to $100,000 each to develop and supply their prototypes for testing by two CLIA-certified independent laboratories.
Deadline for Letter of Intent: August 3, 2018
Deadline for submissions: September 4, 2018
Finalist selection: December 3, 2018
Step Three: Winners Selected
Up to three winners will share an amount equal or greater than $18 million to further develop and produce their prototypes.
Deadline for submissions: January 3, 2020
Winners selected: July 31, 2020
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.
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.
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. These criteria were defined in the September 8, 2016, announcement; however, the announcement incorrectly stated that the Panel will evaluate the solutions based on eight criteria.
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 (e.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.
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.
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.
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.
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 11:59pm 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 11:59pm ET.
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.
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.
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.
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.
Any Solver is eligible for Step 2 of this Challenge competition. For example, if a Step 1 "Solver" was 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 submissions for Step 2, and 3 must be in English.
This page last reviewed on May 5, 2017