About Our Company

IMUGEN, Inc. owns and operates a clinical laboratory located in Norwood, MA, and its staff collectively has decades of experience in the development and performance of specialized testing of clinical specimens for tick-borne diseases.

Background Information:

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 commonly available for Lyme disease indicates that many patients in endemic areas may not be well served by the mass produced commercial test kits. There is a demonstrable need for improved early diagnosis and improved diagnostic accuracy in endemic areas. Working closely with leading clinical researchers, IMUGEN developed improved assays for the laboratory diagnosis of the Borrelia burgdorferi infection (the causative agent of Lyme disease). IMUGEN validated these assays in blinded studies of paired specimens, in correlation studies with clinical symptoms, and with retrospective studies on defined populations. IMUGEN's extensive clinical experience with over half a million tests performed allows it to confidently state that its 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 confounds current ELISA testing, the strength of IMUGEN testing becomes even clearer. IMUGEN has 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 difference of IMUGEN's Lyme testing comes from the specific laboratory techniques used by its technical staff. The diagnostic accuracy of the antibody capture method is coupled with reagents and materials which are internally produced. IMUGEN's detailed understanding of the different behaviors of IgM, IgG, and IgA, at the various stages of infection, allows it to discriminate these stages accurately. This experience is summarized in detailed interpretive comments supplied with each patient report.

The clinical validity of IMUGEN's 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 IMUGEN's 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, as well as, HIV genotyping and drug resistance evaluations. IMUGEN also sponsors seminars and provides written materials concerning the diagnosis of Lyme disease and other tick-borne diseases to improve the utility of its laboratory services. IMUGEN's professional staff also includes four board certified pathologists.

IMUGEN is licensed in the states of Massachusetts, New York, Pennsylvania, and Rhode Island and is accredited by the Clinical Laboratory Improvement Amendments (CLIA) and College of American Pathologists (CAP).

IMUGEN's goal is to provide testing that truly services the needs of the clinicians without encouraging over utilization of tick-borne disease testing.