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Norwood, MA, March, 2000 - IMUGEN Inc is announcing major improvements in its program of testing for tick-borne diseases, which include Lyme disease, babesiosis, and ehrlichiosis. These improvements are extensions of IMUGEN's long-standing expertise in providing accurate and useful tests for these tick-borne.
Testing for Lyme disease has always been problematic, and has been further complicates by the widespread use of Lyme vaccine. Recipients of Lyme vaccine uniformly test positive for Lyme disease on all commercially available enzyme-based (i.e., ELISA) tests for Lyme disease. It had been hoped that simply relying on traditional Western Blotting (WB) would solve this problem of distinguishing Lyme disease from vaccination. However it has been recently shown that Lyme vaccination can lead to confusing WB, and that this test cannot always be relied upon to distinguish vaccinated patients from actually infected ones. Researchers from IMUGEN, in collaboration with Mayo Medical Laboratories, have recently solved this problem by utilizing a new set of reagents deficient in OspA, which have been shown to be highly reliable in addressing this problem. According to Dr. Philip Molloy, the Medical Director at IMUGEN, "These new tests incorporating OspA-free reagents represent a major breakthrough. The treating physician now has available a test that can accurately identify patients with Lyme disease, and not confuse them with those vaccinated against Lyme disease. This test has now been validated in hundreds of patients with various stages of Lyme infection, and in hundreds of specimens from vaccinated patients." Effective immediately, IMUGEN is routinely adding these OspA-free reagents to all Lyme testing.
Another breakthrough involves testing for Human Granulocytic Ehrlichiosis (HGE), another emerging tick-borne infection. Accurate diagnosis of this is crucial since fatal cases have been reported. Traditional serologic methodologies have relied on Indirect Immunoflourescence (IFA), which has suffered from poor sensitivity. IMUGEN has abandoned this now obsolete test in favor of newer generations of serologic tests based upon recombinant HGE antigens, in collaboration with Corixa Corporation, an antigen discovery biotechnology company from Seattle, WA. These new HGE tests have been shown to be far superior in test sensitivity and specificity, and are immediately available from IMUGEN. PCR testing, see below, has also been introduced for the diagnosis of ehrlichiosis.
Babesiosis is another infection transmitted by the same tick that transmits both Lyme disease and babesiosis. IMUGEN has expanded its experience with the serologic testing for babesiosis with the collection of hundreds of cases, many of which are PCR or smear positive, with clinical correlations, and validating the available IgM and IgG serologic testing, and complementing this,
as in the case of HGE, with PCR (see below).
Finally, this year brings the performance of a new generation of PCR testing to IMUGEN, where in-house PCR testing for Lyme disease, babesiosis, and ehrlichiosis is now immediately available. This technology, unlike serology, utilizes sophisticated molecular biological techniques to directly test for the presence of the infecting organism's specific DNA. This can be crucial in the case of Lyme arthritis where the detection of a positive PCR is evidence of persisting infection (which cannot be learned from serologic testing); in the case of early HGE,
where antibodies are not yet detectable; or in the case of babesiosis, where the presence of a positive PCR test late in the patient's course of this potentially chronic infection would indicate persistent infection and be of great help to the physician in deciding upon further treatment. IMUGEN is now offering these new PCR tests in-house immediately.
About IMUGEN: IMUGEN Inc is a privately held company based in Norwood, MA that has pioneered in the research and development of highly specialized testing for tick-borne diseases.
After more than ten years of R&D, more than a half million Lyme tests performed, and the publication and validation of its testing methodologies in peer-reviewed journals, IMUGEN is regarded as the industry leader in the area of testing for tick-borne diseases. It is also expanding its laboratory services to include rheumatologic and autoimmune disorders.
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