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NIH Awards $102.5M for Antibacterial Resistance Research, Dx Development

NEW YORK – The National Institutes of Health has renewed funding for the Antibacterial Resistance Leadership Group (ARLG) with up to $102.5 million over seven years.

The grant starts with $15 million in 2020, awarded by the National Institute for Allergy and Infectious Disease (NIAID) to coprincipal investigators Vance Fowler of Duke University and Henry Chambers of the University of California, San Francisco.

As part of the new grant, ARLG will "support improved diagnostic tests for identifying antibiotic-resistant microbes," NIH said in a statement. ARLG will also work on developing non-antibiotic approaches to fighting those organisms, including vaccines, bacteriophages, and microbiome-altering interventions. ARLG will use funds to maintain centers supporting the network, including a Scientific Leadership Center to provide administrative guidance and oversight; a Clinical Operations Center to provide support for trials and studies; a Laboratory Center to oversee laboratory research and trial specimens; and a Statistics and Data Management Center to assist with study design and analysis.

"The renewal support from the NIAID will allow the ARLG to continue its collaborative work to advance science in antibacterial research, and to provide funding opportunities for the next generation of researchers dedicated to addressing this public health threat," Fowler said in a statement.

"To complement the ongoing research activities of both the diagnostic and the pharmaceutical industries, our ARLG has established collaborative ties with members of both communities. Our long-term research goal is to improve outcomes of multiple-drug resistant bacterial infections by designing and conducting transformational diagnostic and therapeutic clinical trials," the researchers wrote in their grant abstract. "We will pursue this goal in diagnostics by obtaining [US Food and Drug Administration] approval for a host gene expression-based diagnostic and by evaluating the clinical impact of rapid phenotypic testing in patients with bloodstream infection."

Antibacterial resistance has emerged as a global health threat; a US Centers for Disease Control report published this year estimated that 35,000 people in the US die each year due to infections from resistant bacteria. Since 2013, ARLG has coordinated clinical research on antibacterial resistance, including 40 clinical research studies at 130 sites, with collaborations in 19 countries. In 2019, it received $19.2 million in funding from NIAID.

One of the tests will distinguish between bacterial and viral infections and is being developed by Predigen Diagnostics, according to Ephraim Tsalik of Duke University Medical Center, one of the firm's cofounders and associate director of the ARLG Laboratory Center.

"ARLG is providing support for some of the clinical and analytical validation required for submission to the FDA," he said, while the firm, a Duke spinout, is developing the test in collaboration with Biomeme, a firm developing a portable real-time PCR instrument.

Tsalik recently led a validation study for the test in collaboration with multiple institutions, published in October in EBioMedicine

As reported by GenomeWeb in January, Predigen is planning to submit a product to FDA for review in 2022.