DANBURY, CT - The goal of finding a more effective test to diagnose Lyme disease may be closer to reality with a two-year, $600,000 grant from the National Institute of Allergy and Infectious Disease (NIAID) Small Business Innovation Research Program (SBIR) awarded to RareCyte, Inc. in collaboration with researchers from the Western Connecticut Biomedical Research Institute. Lyme disease, a tick-borne infection caused by the spirochete Borrelia burgdorferi, has expanded to an estimated 300,000 US cases per year with many communities calling it a public health imperative. Currently as many as half of those approved tests of immune response are sub-optimal and often give negative results early in the disease causing painful delays in treatment and even misdiagnosis. Better testing will enable earlier detection – and hence better treatment – of Lyme disease.
Dr. Ramin Ahmadi, Chair, Department of Medical Education and Research shared; “We know that many people suffer the debilitating effects of Lyme disease and it is a priority for us to seek out new pathways to diagnosis and treatment. We are excited by our early findings and grateful to the NIAID for this opportunity to further our research in order to improve testing and restore health to those affected by this terrible disease.”
The scientists have developed an assay method for direct visualization of the Lyme infection in blood that combines RareCyte’s density-based separation and enrichment technology for rare cells with immunofluorescence microscopy. The assay could have significant impact on the state of current Lyme disease diagnostics.
Ron Seubert, CEO of RareCyte, Inc stated, “We are extremely pleased with our fruitful collaboration with Dr. Paul Fiedler and his group at the WCHN Biomedical Research Institute. Development of more sensitive and accurate methods of direct detection of Borrelia burgdorferi for the purpose of diagnosing Lyme disease patients is a high-priority area of interest for NIAID. Dr. Fiedler understood the utility of RareCyte technology when applied to Lyme disease, and the SBIR grant is further recognition of that utility.”
Dr. Eric Kaldjian, CMO of RareCyte, is the Principal Investigator on the grant. In a preliminary pilot study, the team, which also includes Dr. Denise McKibben and Donna Guralski at WCHN and Dr. Joshua Nordberg of RareCyte, analyzed blood samples of a small cohort of patients clinically diagnosed with acute Lyme disease using RareCyte technology before, during and after antibiotic treatment. In all patients, B.burgdorferi-positive staining objects were identified in the blood. In some cases the positive staining objects persisted even after antibiotic treatment had been completed. “Based on these preliminary results, we see a potential for monitoring symptomatic patients for response to antibiotic therapy as well. However, the RareCyte assay for Lyme disease detection requires further development and study before it can be made available for routine clinical use. The SBIR grant will support that effort,” said Dr. Kaldjian.
Lyme disease research advocate, Senator Richard Blumenthal states, “The lack of advanced diagnostic technology and adequate information about this pernicious disease means Lyme all too often goes undetected in its victims, ultimately causing lasting and devastating harm. This grant will fund important strides in understanding Lyme disease, helping lead to earlier detection and better treatment of the illness. The Western Connecticut Biomedical Institute is a trailblazer in this effort. Their research will further efforts to better understand the effects of this epidemic and the best ways in which we can protect ourselves from it.”
The research will be supported by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health under Award Number R43AI113990.