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Developing A Better Test For Lyme Disease Diagnosis…

Wednesday, August 06, 2014 - Danbury, CT

Paul Fiedler, M.D.

Paul N. Fiedler, M.D.
Chairman, Department of Pathology and Laboratory Medicine
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Western Connecticut Health Network Biomedical Research Institute Partnership With RareCyte To Improve Lyme Disease Testing Wins NIAID SBIR Research Grant

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.

About Rarecyte, Inc.

RareCyte is a life science company dedicated to building technology that enables the analysis of rare circulating cells across the spectrum of disease. Many of the answers to difficult clinical questions in cancer, prenatal diagnostics and infectious disease may lie in the analysis of rare cells.

RareCyte's interdisciplinary team of biologists and engineers has developed a powerful technology platform for identification and retrieval of rare circulating cells and pathogens. The platform includes AccuCyte technology for density-based enrichment, collection and transfer of cells from blood to microscopic slides; the automated CyteFinder digital microscope scanning system for cell identification and characterization; and integrated CytePicker for precision single-cell retrieval for molecular analysis.

For further information please visit our web site at Rarecyte.com.

About Lyme Disease

Lyme disease is caused by the bacterium Borrelia-burgdorferi and is transmitted to people via the bite of infected blacklegged ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash resembling a bulls-eye. If left untreated, the Lyme infection can spread to joints, the heart, and the nervous system. Some patients complain of lingering symptoms beyond a course of antibiotics. Lyme disease is diagnosed based on symptoms, physical findings (i.e. bulls-eye-like rash), the possibility of exposure to infected ticks and laboratory testing.

About Lyme Prevention

The Lyme Disease Data registry recommends residents be vigilant in practicing the BLAST prevention methods of Bathing; Looking for ticks; Applying repellant; Spray your yard; and, Treat your pets to prevent tick bites.

About the Lyme Data Registry

The Western Connecticut Health Network Lyme Disease Registry is building a comprehensive database of patients with Lyme disease. The Registry is working to understand the big health problems caused by this very small bug. This work is the basis for multidisciplinary research leading to a better understanding of the course of the disease; how people are affected; and the causes of persistent symptoms. The Registry goal is for the research to lead to better testing, diagnosis and treatment of Lyme disease.

The Registry has locations in Danbury, New Milford and Norwalk, CT. For more information on how you can help contact the Western Connecticut Lyme Disease Registry at (203) 739-8383; or via Facebook at facebook.com/lymeregistry.

About Western Connecticut Health Network

Western Connecticut Health Network is the region's premier, patient-centered health care organization serving residents of Western Connecticut and adjacent New York. With this recent affiliation, the organization is now anchored by three nationally recognized hospitals, Danbury Hospital, New Milford Hospital and Norwalk Hospital, as well as their affiliated organizations. In addition to the three hospitals, the continuum of care offered includes numerous medical practices and sub-specialties across the region, home health care services, a nationally renowned biomedical research institute, the Western Connecticut Health Network Foundation, the Norwalk Hospital Foundation and other affiliates. For more information, visit TheNewWCHN.org. Share your comments with us at Facebook.com/DanburyHospital; Facebook.com/NewMilfordHospital and/or Facebook.com/NorwalkHospital.




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