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A federal challenge
BETHESDA, Md.—Antibiotic-resistant bacteria is a rising public health threat, causing at least two million infections and 23,000 deaths each year in the United States, according to the U.S. Centers for Disease Control and Prevention (CDC). Now a federal prize competition calls for innovative ideas for rapid, point-of-care laboratory diagnostic tests to combat the development and spread of drug-resistant bacteria.
The Antimicrobial Resistance Diagnostic Challenge will award $20 million in prizes over all phases of the competition for new, innovative and novel laboratory diagnostic tests that detect and distinguish antibiotic-resistant bacteria. The diagnostic tests being sought are those that identify and characterize antibiotic-resistant bacteria and those that distinguish between viral and bacterial infections to reduce unnecessary use of antibiotics, which is a major cause of drug resistance. The prizes are sponsored by two U.S. Department of Health and Human Services (HHS) components: the National Institutes of Health (NIH) and the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR)—within ASPR resides the Biomedical Advanced Research and Development Authority, or BARDA—in support of the National Action Plan for Combating Antibiotic Resistant Bacteria.
“The growing incidence of serious infections from antibiotic-resistant bacteria presents a critical risk to the public health of our nation,” said NIH Director Dr. Francis S. Collins. “My hope is that this competition will spur exceptional innovators to rise to the challenge and deliver effective tools to help manage this significant problem.”
According to Dr. Robert W. Eisinger, special assistant for scientific projects at NIH’s National Institute of Allergy and Infectious Diseases (NIAID), “NIH and BARDA have supported and continue to support a comprehensive portfolio of research programs on antimicrobial resistance (AMR). These programs include basic research, preclinical studies and clinical trials leading to the development of new and better strategies to prevent, treat and control AMR. The Antimicrobial Resistance Diagnostic Challenge was called for in the White House Fact Sheet issued in September 2014, when the White House released the National Strategy for Combating Antibiotic-Resistant Bacteria. The National Action Plan for Combating Antibiotic-Resistant Bacteria includes a specific goal to ‘Advance the Development and Use of Rapid and Innovative Diagnostic Tests for Identification and Characterization of Resistant Bacteria.’”
“Under that goal, there was a specific timeline that within three years of the issuance of the report that ‘NIH and ASPR/BARDA will establish a prize for development of a rapid diagnostic test that can improve treatment of drug-resistant infections and facilitate antibiotic stewardship.’ Within five years of the issuance of the report, ‘NIH and ASPR/BARDA will manage and administer a prize contest for development of a rapid diagnostic test that can improve treatment of drug-resistant infections and facilitate antibiotic stewardship,’” continues Eisinger.
With real-time diagnostics tools, healthcare providers would be able to identify infecting pathogens and resistance factors within hours, rather than the two to three days or longer that the standard microbiological culture processes require. Such knowledge would allow tailoring of treatments, minimizing the broad-spectrum antibiotic approach used by many clinicians today.
According to Eisinger, “The challenge competition seeks to incentivize the development of diagnostic tests that would enable healthcare providers to make more informed decisions on appropriate antibiotic use (antibiotic stewardship) and infection prevention. We believe this challenge will stimulate investment from both private and public sectors in rapid, point-of-need in-vitro diagnostic research and development, which could facilitate clinical trials of new antibacterial products and advance the development of new antibacterial agents. Winners of the challenge will not be required to transfer their exclusive intellectual property rights to the NIH or ASPR. Winners will grant to the federal government a nonexclusive license to practice their solutions and use the materials that describe them.”
Concepts must be submitted by Jan. 9, 2017, for the first phase of the competition. Up to 20 semifinalists will be selected, each receiving up to $50,000. In the second phase, on Dec. 3, 2018, up to 10 finalists will be selected to each receive up to $100,000. These funds can be used to develop prototypes for evaluation by two CLIA-certified independent laboratories, which will be considered when final winners are selected. In the final phase, winners are expected to be announced on July 31, 2020. The competition specifies that up to three winners can be selected, and winners will share an amount equal to or greater than $18 million.
“The time between the announcement of the 10 semifinalists from Phase 2 until their submission for Phase 3 allows the 10 semifinalists time to refine their prototypes and prepare a sufficient number of prototypes for submission to step three. Step three involves testing the prototypes using clinical and contrived samples by two independent CLIA-certified laboratories,” Eisinger explains. “Testing the prototypes will take several months. The results from these two CLIA-certified laboratories will be provided to the judging panel in May 2020 before the winner(s) of the prize will be announced.”
Eisinger tells DDNews that the judging panel will involve senior leadership from the NIH/Office of the Director/Division of Program Coordination, Planning and Strategic initiatives; NIH/NIAID; and BARDA. The Secretary of the HHS will be the approving official for the challenge.
The NIAID and BARDA have each contributed $10 million to the challenge. Eisinger says the funds for the prize competition come from NIAID’s and BARDA’s budget for fiscal year 2016. The CDC and the U.S. Food and Drug Administration have provided technical and regulatory expertise to the design of the challenge competition. Technical criteria, objectives and performance characteristics of laboratory diagnostics that would be considered for the prize were informed by stakeholder input from a public workshop and a request for information.