Antimicrobial Resistance Diagnostic Challenge

Antimicrobial Resistance Diagnostic Challenge is sponsored by HHS ASPR BARDA. Funding for the development of innovative diagnostics to detect antimicrobial-resistant pathogens.

NOT-OD-16-137: Announcement of Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge Competition Announcement of Antimicrobial Resistance Rapid, Point-of-Care Diagnostic Test Challenge Competition Notice Number: NOT-OD-16-137 Release Date: September 8, 2016 National Institutes of Health ( NIH ) Biomedical Advances Research and Development Authority (BARDA) The U.S. Department of Health and Human Services (HHS) is holding a challenge prize competition in which up to $20 million will be made available, subject to the availability of funds, for the delivery of one or more novel and innovative in vitro point-of-care diagnostics 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.

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 sponsoring the prize competition for novel, innovative solutions for use in inpatient and/or outpatient settings.

This Challenge, structured in three steps, will incentivize a broad range of scientists, engineers, and innovators to develop in vitro diagnostic tests that would enable health care providers to make more informed decisions on appropriate antibiotic use and infection prevention. This competition may lead to the development of more sensitive, accurate, robust, and cost-effective assay approaches and devices for clinical diagnosis.

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 under the America COMPETES Reauthorization Act, 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.

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 setting. 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 competition, 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: 1) improve antibiotic decision making by health care providers and be effective in reducing inappropriate use of antibiotics 2) 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 health care providers to: 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.

To register and submit for this Challenge, Solvers may access the registration and submission platform from any of the following: 1) Access the www. challenge. gov website and search for Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test.

2) Access the Antimicrobial Resistance Rapid, Point-of-Need Diagnostic Test website; a registration link for the Challenge can be found on the landing page under Challenge Description. 3) Access the website of the Challenge administered for NIH by Capital Consulting Corporation at http://www. cccinnovationcenter.

com/challenges/antimicrobial-resistance-diagnostic-challenge/ For more information about eligibility requirements, competition rules, and deadlines for submissions, please consult the Federal Register . Please direct all inquiries to: Robert W. Eisinger, Ph.

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