Researchers from Yale University, in collaboration with Luna Bioscience, Inc., have unveiled a revolutionary diagnostic method that detects leptospiral Virulence-Modifying (VM) proteins in the blood and urine of infected animals, paving the way for early diagnosis, supporting vaccine development and improved understanding of leptospirosis pathogenesis. “This is the first systemic bacterial disease mediated by a toxin (such as tetanus, botulism, diphtheria) that has the potential for rapid antigen/antibody detection by a novel test, with direct implications for similar test development for other veterinary diseases,” says research team leader Dr. Joseph M. Vinetz.

The research has led to the development of monoclonal antibody (mAb)-based capture immunoassay and antibody/antigen detection-based diagnostic tests. These assays directly detect VM proteins and animal antibody responses to these proteins, a recently identified family of leptospiral proteins crucial for disease pathogenesis. The findings are detailed in a paper published in the September 29 online issue of Microbiology Spectrum.  https://doi.org/10.1128/spectrum.00018-25 

"We have long known that leptospirosis severely impacts multiple organ systems in dogs, leading to conditions like jaundice, acute kidney injury, and pulmonary haemorrhage," said Dr. Vinetz. Furthermore, in livestock, rapid diagnosis in individuals and herds promises to improve animal health. "Our discovery of these VM proteins as circulating exotoxins gives us a specific target for both diagnostics and potential therapeutic interventions."

The assay's success in detecting VM proteins lays the groundwork for developing rapid, inexpensive lateral flow diagnostics suitable at point of care, for both veterinary and human use. Such tools are particularly crucial for resource-limited settings where leptospirosis is most prevalent.

This study was supported by the National Institutes of Health and the America's Foundation, with significant contributions from Luna Bioscience, Inc.

For further information, please contact:

Carla Devillers, CEO, Luna Bioscience, Inc.

  carla@lunabioscience.com    +1 (917) 545-7262

Dr. Joseph M. Vinetz
Section of Infectious Diseases, Department of Internal Medicine
Yale University School of Medicine

joseph.vinetz@yale.edu

Yale University Office of Public Affairs & Communications

public.affairs@yale.edu

About Luna Bioscience:

Luna Bioscience, Inc. is a spin-out from Yale University developing solutions for animals and humans to emerging global infectious diseases through novel vaccines, diagnostics and therapeutics. Luna has been supported by a series of peer-reviewed NIH small business grants, a testament to the rigorousness and clinical relevance of its translational science.

About Yale School of Medicine:
Yale School of Medicine, founded in 1810, is a world-renowned center for biomedical research, education, and advanced health care. It ranks among the top medical schools in receipt of research funding from the National Institutes of Health and is a vital part of Yale University.

Source:
Chaurasia R, Jacobs A, Tang J, Dong S, Vinetz JM. Development of Leptospiral Virulence-Modifying Protein Detection Assay: Implications for Pathogenesis and Diagnostic Test Development. Microbiology Spectrum. 2025, embargo release date, 9-29-2025

MORE on LUNA BIOSCIENCE:

Luna Bioscience has established robust data providing a pathway for collaborating with a major development partner for vaccine and rapid diagnostic test development for leptospirosis in dogs and food-producing animals.

Luna’s co-founder and chief executive Carla Devillers told XYZ media outlet that the industry’s top players are interested in the firm’s leptospirosis vaccine and diagnostics, as Luna’s R&D developments are a major improvement on the currently available vaccines that are based on whole killed bacteria. Further, Devillers said that the advent of rapid diagnostics will enable improved case identification, driving further novel leptospirosis vaccine development.

The New Haven, Connecticut-based start-up is working on a universal one-shot leptospirosis vaccine that can provide long-term protection against all Leptospira species and serovars– current vaccines tend to be for 2-5 serovars at a duration of 6-12 months. Luna also believes its recombinant protein approach can produce vaccines with a low cost of goods in comparison to currently marketed products.

The start-up’s advisory board includes animal health industry experts such as Dr. Judy Jarecki-Black (former global head of intellectual property at Merial) and Dr. Fabian Kausche (previously head of global R&D at Boehringer Ingelheim Animal Health as well as chair of PetMedix).