LYME TESTING AT IMUGEN, INC.


* Proven and published sensitivity and specificity (CDC Study)

* Established clinical validity (peer reviewed publications)

* Laboratory of choice in highly endemic areas for cost effective primary and
reference testing

* Unique testing panel includes IgG, IgM, and IgA capture assays and immunoblotting to allow diagnosis as well as staging of infection

* Approved by major insurance carriers, HMO's, Medicare and licensed in all states
including New York

* Exceptional interpretive data and consultation easily available with professional staff.

* Professional staff includes four board certified pathologists

* Acute and convalescent testing - samples stored for minimum of six 
years to enable comparative follow-up analysis

* Ability to distinguish vaccinated patients from true Lyme infections

* Ability to distinguish Ehrlichia and Babesia from Lyme infections


IMUGEN, INC. - BACKGROUND

Failure to diagnose Lyme disease early increases the risk of long term complications including neurologic and arthritic manifestations. Misdiagnosis may result in inappropriate treatment and failure to appropriately treat the true cause of clinical symptoms simulating Lyme disease.

Epidemiologic analysis of the testing routinely available for Lyme disease indicates that many patients in endemic areas are not well served by the mass produced commercial screening tests. There is a demonstrable need for improved early diagnosis and improved diagnostic accuracy in endemic areas. Working closely with leading clinical researchers we developed improved assays for the laboratory diagnosis of the Borrelia Burgdorferi infection, (the causative agent of Lyme disease). We validated these assays in blinded studies of paired specimens, in correlation studies with clinical symptoms, and with retrospective studies on defined populations. Finally our extensive clinical experience with over half a million tests performed allows us to confidently state that our tests for Lyme disease have a sensitivity, specificity, and predictive value which is known and unmatched by other testing procedures. 

With the availability of the Lyme vaccine, which renders current ELISA testing useless, the strength of IMUGEN testing becomes even clearer. We have worked during vaccine trials with numerous physicians and can clearly identify true infection from vaccination. Current ELISA testing will simply provide a false positive result, further complicating the physicians ability to truly treat an infected patient and therefore creating larger downstream costs to an already burdened healthcare system.

Part of the unique power of IMUGEN Lyme testing comes from the specific laboratory techniques used by our technical staff. The diagnostic accuracy of the antibody capture method is coupled with reagents and materials which are locally produced. These materials cannot be readily manufactured which prevents the commercialization of our tests into widely available "kits". Our detailed understanding of the different behaviors of IgG, IgM, and IgA at the various stages of infection, allows us to discriminate these stages accurately. This experience is summarized in our detailed interpretive comments supplied with each patient report.

The clinical validity of our approach has been demonstrated in several studies. The superiority has been demonstrated in a blinded trial with CDC and a community hospital performing "commercialized" testing in a hyperendemic area.

Lyme disease is complex and often cannot be diagnosed solely on clinical indications. Laboratory testing must be of the highest accuracy since the clinical symptoms are generally not specific. Treatment is most effective in the early stages prior to dissemination of the infection, paradoxically the time period during which the commonly employed ELISA test is least sensitive. Thus our testing becomes the method of choice for patients in highly endemic areas for Lyme disease (i.e. Southeastern Massachusetts, Cape Cod, The Islands, New York and Long Island, Connecticut, Rhode Island, New Jersey and Pennsylvania). 

IMUGEN has pioneered testing for other vector borne diseases including state of the art testing for Babesiosis and Ehrlichiosis. Imugen also sponsors seminars and provides written materials concerning the diagnosis of Lyme disease and other Tick borne diseases to improve the utility of our laboratory services. Our professional staff includes four board certified pathologists as well. 

Our goal is to provide testing that truly services the needs of the clinicians without encouraging over utilization of Lyme testing.

IMUGEN PERSONNEL

Victor P. Berardi: CEO and SENIOR SCIENTIST, formerly Chief of Virology at the Massachusetts State Laboratory Institute, Department of Public Health. Victor has pioneered in the development of antibody capture EIA's, OspA-free testing for Lyme disease and Lyme vaccine exposure, and the use of recombinant antigens and PCR in the diagnosis of HGE. He is past Chairman, Clinical Virology, Northeast Association for Clinical Microbiology and Infectious Diseases, and is widely published in the area of laboratory diagnosis of all of the tick-borne diseases.

Philip J. Molloy, M.D.: MEDICAL DIRECTOR, AND private rheumatology practice in a highly endemic area for Lyme disease. Phil is a member of the Massachusetts Department of Public Health's Lyme Disease Advisory Committee, and the co-author of many publications on the serologic and immunologic characterization of Lyme arthritis patients. He is currently actively involved in the research on the correlation of clinical features and laboratory findings in patients with various manifestations and stages of Lyme infection.

David H. Persing, M.D., Ph.D.: DIRECTOR OF LABORATORY SCIENCE, also serves as a vice president and the Medical Director of the Infectious Disease Research Institute of Corixa Corporation, Seattle, WA. David is formerly Associate Director of Laboratory Medicine and Pathology, Mayo Medical School. He is the author of numerous publications on diagnosing various infectious diseases, and is on the editorial boards of the Journal of Clinical Microbiology, Molecular Diagnosis, Diagnostic Microbiology and Infectious Diseases, Journal of Infectious Diseases, Emerging Infectious Diseases, and New England Journal of Medicine, and serves on the IDSA Practice Guidelines Committee on Lyme Disease.

Alan M. Sugar, M.D.: DIRECTOR OF ANTI-FUNGAL DIVISION, also serves as the Director of the Clinical Mycology Center and Infectious Disease Consultant at Boston University Medical Center. Alan is the editor-in-chief of the Journal of Clinical Research Practice, and is on the editorial boards of Antimicrobial Agents and Chemotherapy, Journal of Microbiology, Diagnostic Microbiology and Infectious Diseases, and the International Journal of Antimicrobial Agents.
He is extensively published on all aspects of fungal infections and anti-fungal agents.

Lionelle D. Wells, M.D.: DIRECTOR OF LABORATORY SERVICES, Fellow College of American Pathologists, is licensed in Massachusetts and New York. Lee is formerly the Director of Laboratory Services for Harvard Pilgrim Healthcare of New England, and is the Massachusetts Eastern Divisional Commissioner for the College of American Pathologists Accreditation Program, and is a faculty for many CAP inspector training seminars nationally and internationally. He is Assistant Clinical Professor of Pathology at Tufts University School of Medicine, and Pathology Instructor, Harvard Medical School, Boston, MA.

Other Laboratory Personnel: IMUGEN employs a highly trained and experienced staff.
Our SENIOR TECHNICIANS have devoted their past 15 years to specialized serologic and molecular diagnostic test development for tick-borne infections, and serve as Corporate Vice Presidents of IMUGEN. They have pioneered in the development of capture EIA's, WB tests, OspA-free test reagents, recombinant HGE test antigens, and PCR, and have published on test refinements for tick-borne diseases in peer reviewed journals.

220 Norwood Park South
Norwood, MA 02062
1-800-246-8436
1-781-255-0770