New Urinary Tract Infection Diagnostic Gains Funding

Escherichia coli, or E. coli, bacteria (National Institute of Allergy and Infectious Diseases)

15 May 2018. A company developing a desktop system for diagnosing urinary tract infections in as little as 30 minutes is the recipient of grant funding from a public-private consortium to combat drug-resistant microbial infections. MicrobeDx in Los Angeles is eligible to receive $3.5 million for its diagnostic technology from the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator, or CARB-X, a coalition of government agencies, foundations, and academic institutions in the U.S. and U.K.

MicrobeDx is creating diagnostic tests that analyze RNA molecules in bodily fluids. The company’s first product tests for urinary tract infections, which occur most often in women, and in the bladder and urethra. If left untreated, these infections can spread to the kidneys or beyond with serious consequences. National Kidney Foundation says urinary tract infections are responsible for some 10 million doctor visits a year in the U.S., with at least 1 in 5 women likely to have an infection in her lifetime. Escherichia coli, or E. coli, bacteria are a leading cause of urinary tract infections, with many infections contracted in health care facilities, resulting from drug-resistant bacteria.

Most urinary tract infections are treated with antibiotics, but according to MicrobeDx, antibiotic treatments are often prescribed before the infection is diagnosed. The reason, says the company, is the extended time needed, about 72 hours, to identify the bacterium responsible for the infection, and complete antibiotic susceptibility testing that reveals resistance to the likely prescribed drugs. MicrobeDx says its technology can identify the bacterial target in 30 to 45 minutes, with antibiotic susceptibility testing and personalized prescriptions completed in under 3 hours, thus avoiding unnecessary or erroneous prescriptions.

The MicrobeDx technology captures and analyzes RNA in bodily fluids, in this case urine samples. The automated analysis specifically targets ribosomal RNA, the molecules that translate instructions in messenger RNA for synthesizing proteins from amino acids. The company says the captured ribosomal RNA can be analyzed in its natural state, without further amplification. MicrobeDx says its system can analyze 100,00 molecules simultaneously in a cell, but can also work with small samples of microbes to provide specific identification of the suspect bacteria.

CARB-X, in Boston, is providing an initial payment of $900,000 for development of the urinary tract infection, or UTI, diagnostic system, with MicrobeDx eligible for another $2.6 million if all progress milestones are achieved. “MicrobeDx aims to speed the diagnosis and treatment of UTIs,” says Kevin Outterson, executive director of CARB-X in a statement, “taking the guesswork out of treatment decisions in the first critical hours of illness. The world urgently needs new diagnostics and other products to protect us from life-threatening drug-resistant bacteria.”

CARB-X is an initiative of Biomedical Advanced Research and Development Authority, or BARDA, an agency of the U.S. Department of Health and Human Services, National Institute of Allergy and Infectious Diseases, or NIAID, and the Wellcome Trust, a foundation based in London, that provide the funding or in-kind services. Partnering organizations include Boston University law school where CARB-X is headquartered, as well as the Broad Institute of MIT and Harvard, Massachusetts Biotechnology Council, California Life Sciences Institute, AMR Centre in the U.K., and RTI International.

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