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The skyrocketting need for speed: partnering to develop rapid diagnostic tests that protect patients from antibiotic resistant infections during disasters and every day

Author: Rick Bright, Ph.D., BARDA Director and Deputy Assistant Secretary for Preparedness and Response
Published Date: 1/8/2020 1:32:00 PM
Category: Medical Countermeasures; National Health Security; Public Health Preparedness; Hospital Preparedness; Innovations;

Relatively minor injuries, like a cut that I got while gardening, can quickly become more serious if they become infected with antibiotic-resistant bacteria. Today, doctors often don’t have the diagnostic tests needed to inform patient care, and the tests that do exist may take too long to provide results. Without this vital information, doctors don’t have the information they need to ensure patients are getting the right antibiotics, serve as good stewards of antibiotics to prevent resistance, or when to isolate patients or take other precautions during the provision of everyday care.

The scale of antibiotic resistant infections is staggering. Every 11 seconds, in the United States alone, someone is infected by drug-resistant bacteria. Every 15 minutes, one of those people die, totaling at least 35,000 each year. Medical professionals and patients need rapid diagnostics every day to inform patient care, but the right tool or right drug sits just outside their reach.

In a public health emergency, the need for speed really skyrockets. Antimicrobial resistance threatens health security because every health threat – whether biological, chemical, radiological, or pandemic – leads to secondary bacterial infections that are increasingly antibiotic resistant, and many of the biological threats our nation faces can be genetically engineered to be antimicrobial resistant. To make matters worse without effective therapies, these infections can rapidly lead to sepsis, the body’s extreme, even life-threatening, response to an infection.

Each year, 1.7 million Americans get sepsis.  Each year, nearly 270,000 Amricans die from it.  Sepsis is a leading cause of hospital readmissions and one of the most costly conditions treated in U.S. hospitals.  Sepsis is a major systematic health threat in the U.S. and it poses an even greater threat in the event of a Chemical, Biological, Radiological, or Nuclear (CBRN) incident. Every hour delay of initiating the correct treatment to a person with sepsis reduces their chance of survival by eight percent.

To save as many lives as possible, medical professionals across the country will need diagnostics that can differentiate bacteria from viruses, indicate in minutes which bacteria is infecting their patients, and whether that bacteria has developed antimicrobial resistance. Consider the sheer number of diagnostics and the speed needed in bio-incident or severe pandemic. The diagnostics arena is ripe for innovation as well as full implementation of new technologies already developed. Progress also requires that new technologies be integrated quickly into our healthcare system, which presents an additional challenge.

This year one of the five of BARDA-supported diagnostics for AMR infections was designated as a Breakthrough Device by the U.S. Food and Drug Administration, allowing the company to work more closely with FDA toward clearance. That diagnostic, called the T2Resistance Panel from T2 Biosystems, shows promise in detecting 13 resistance genes from both gram-positive and gram-negative pathogens from a single patient blood sample without waiting for blood culture. BARDA is providing expertise and funding for advanced development of the diagnostic, which became the first diagnostic to graduate into our advanced R&D portfolio from our CARB-X partnership.

BARDA also just announced a new partnership with Inflammatix to develop 3 point-of-care diagnostic tests that use gene expression patterns in the immune system to distinguish bacterial infections from viral infections and determine the severity within 20-30 minutes. The first Inflammatix test, called HostDx Fever, is intended to distinguish bacterial from viral infections in outpatient ambulatory settings; the second test, called HostDx Sepsis, is intended for inpatient hospital settings and also may determine whether a patient is likely to develop sepsis. The third test, HostDx FeverFlu, is intended for use in either setting during influenza season and combines rapid flu testing with host-response data.

Though these innovative products hold the potential to provide clinicians with critical information, they have not been FDA-approved and there is still much work do to strengthen the pipeline of products that can be used to diagnose antibiotic resistant infections.

We are looking for more partners to join us in the fight against antibiotic resistance. CARB-X is now the world’s largest public-private partnership dedicated to early R&D for products that combat antimicrobial resistant bacteria. Currently CARB-X provides funding and business support for four other diagnostics to identify antimicrobial resistant infections, as well as vaccines and novel antimicrobials.

BARDA’s Division of Research, Innovation and Ventures (DRIVe) feeds our diagnostic development pipeline through ENACT, Early Notification to Act, Control and Treat. The focus of this dynamic team is to drive diagnostics and actionable health information close to the patient, to the home and on the body. The goal is to inform a patient and their healthcare provider of infection before they even have symptoms.

If you are a product developer with an innovative idea to enhance for new diagnostic tests to combat antibiotic resistance and an interest in partnering with us, we would love to hear from you. To take the first step, submit your request to discuss your ideas with us at a TechWatch meeting.


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