Diagnostic Testing Plays Key Role in National Antibiotic Resistance Initiative

As we mentioned in our February issue covering the 2016 Budget, efforts to thwart antibiotic resistance are receiving substantial funding. That's because according to the Centers for Disease Control and Prevention (CDC), 2 million illnesses and 23,000 deaths annually can be linked to antibiotic resistance. The White House has established a Forum on Antibiotic Stewardship that brings together public and private entities across multiple industries to develop strategies to fight antibiotic resistance. With multiple legislative, public health and private initiatives working to solve the problem, laboratory diagnostics can play a central role in the fight.

HHS' Initiatives
The U.S. Department of Health and Human Services (HHS) Secretary Sylvia Mathews Burwell and U.S. Department of Agriculture (USDA) Secretary Tom Vilsack highlighted efforts of their organizations in a recent HHS Blog post. HHS' Centers for Medicare and Medicaid Services (CMS) and the CDC will work to establish best practices for hospitals and other facilities and to track antibiotic use and resistance. The National Institutes of Health and the Biomedical Advanced Research and Development Authority are seeking public input on the parameters of a contest that would award up to $20 million (contingent on availability of funding) for development of point-of-care in vitro diagnostic tests that can be used to quickly identify bacterial infections, according to the HHS Blog post. A June 2 announcement of the public comment period regarding the contest indicates comments are due by July 17, 2015 and may address diagnostic performance, speed, cost, and technologies, among other topics.

Together, the CDC, USDA and U.S. Food and Drug Administration (FDA) expect to hold a summer 2015 public meeting to address antibiotic use and resistance in food-producing animals. The FDA has also proposed regulations regarding sales reporting requirements relating to antibiotics usage in food-producing animals and finalized requirements for use and oversight of antibiotics under the Veterinary Feed Directive.

White House Forum
A White House fact sheet announcing the White House Forum on Antibiotic Stewardship, said it would include over 150 entities from the food, retail, health care, and agricultural sectors. Participants commit to make changes over the next five years to "slow the emergence of resistant bacteria and prevent the spread of resistant infections." That announcement included emphasis on private sector efforts to help develop "new antibiotics, therapeutics, diagnostics, and vaccines." For example, Ascension Health's antimicrobial stewardship program will "evaluate facility antibiograms (the result of a laboratory test for the sensitivity of an isolated bacterial strain to different antibiotics)." Hospital Corporation of America is also committed to using "real time antibiogram tracking to rapidly respond to lab results, catch bug-drug mismatches" and avoid health care associated infections and report antibiotic resistance. The White House calls for better and faster testing to improve treatment decisionmaking. Participants BD Diagnostics and BioMerieux are listed as entities contributing to the effort. BD will be developing "rapid carbapenem-resistant Enterobacteriaceae diagnostic tests, new antibiotics to test antibiotic susceptibility testing platforms, and molecular multidrug resistant-tuberculosis diagnostic test to simultaneously test patients for bacteria and resistance, and pioneer new ways to examine and reduce C. difficile healthcare-associated infections." BioMerieux's efforts include work with the federal government "to ensure next-generation sequence-based typing of pathogens to track patterns; create high-medical-value multiplex assays combining host resistance markers, pathogen detection and antimicrobial resistance markers to rapidly diagnose (within approximately 1 hour) the cause of an infection to more accurately tailor empiric and definitive therapy; and validate biomarkers that can differentiate bacterial from viral infections in large cohorts to determine the best combination of markers in a single rapid diagnostic assay."

Other Efforts
Other current efforts in the fight against drug resistance include:

• Executive Order 13676 (Sept. 2014) addressing federal efforts to fight antibiotic resistance;
• A President's Council of Advisors on Science and Technology report recommending how to fight antibiotic resistant infections;
• National Action Plan for Combating Antibiotic-Resistant Bacteria—identifying federal efforts needed to "enhance diagnosis and treatment and limit the spread of antibiotic-resistant bacteria"; and
• A Presidential Memorandum promoting responsible use of antibiotics in meat and poultry.

Takeaway: Diagnostics play a pivotal role in coordinated federal efforts to fight antibiotic resistance.