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Back To Vidyya New Technology Can Discriminate Between Lyme Vaccine Reactions And True Lyme Disease

New Patent Issued

Imugen, Inc. has announced the issuance of U.S. Patent #6,045,804 for an exclusive technology for laboratory tests that differentiate Lyme vaccine response from true Lyme infection.

The patent was issued to the Mayo Foundation for Medical Research and Education, and Imugen has obtained an exclusive license agreement from the Foundation that allows use of the technology.

Utilizing this proprietary technology, Imugen, Inc. has developed new laboratory tests capable of detecting Lyme infection in people who have been vaccinated against the disease. Because some Lyme disease vaccine recipients who live or work in endemic areas may have previously contracted Lyme disease and may still be at risk for the disease, it is crucial for laboratory tests to be capable of differentiating vaccine response and true infection. Vaccine recipients may be at risk of contracting Lyme while undergoing vaccine regimens, and, because the long-term efficacy of the vaccine has not yet been established, there is a risk of contracting the disease after the loss of vaccine efficacy.

"Difficulty in properly diagnosing Lyme infection in vaccine recipients is an emerging problem," said David Persing, MD, Director of Laboratory Science at Imugen. "We are only seeing the tip of the iceberg in the last two Lyme seasons. As more and more people receive the vaccine the problems associated with it will compound, confusing physicians and creating escalating costs in patient care. The answer to the question of true infection in vaccine recipients lies in these new assays."

A 1998 conference on laboratory diagnosis of Lyme disease convened by the National Institute of Allergy and Infectious Diseases (NIAID), Centers for Disease Control (CDC), and Office of Rare Diseases (ORD) recommended that "only bacterial antigens derived from OspA-deficient mutant of Borrelia burgdorferi be used in all diagnostic assays to circumvent false positive reactions likely to result from the use of OspA Lyme vaccines." The new Imugen tests utilize OspA deficient antigens from mutant Borrelia burgdorferi.

"Imugen is very pleased to be able to offer these assays," said Victor Berardi, CEO of Imugen. "By incorporating the OspA deficient strains into our test system, we have circumvented any problems of proper diagnosis stemming from vaccination."

The Lyme vaccine, approved by the FDA and released in December of 1998, has a reported efficacy of 78%. The vaccine is made of a recombinant protein (OspA). Patients receiving the vaccine are maximally protected after three doses. After two doses, the reported efficacy is 50%. The long-term efficacy has yet to be determined. The vaccine's manufacturer, SmithKline Beecham, has not yet established booster recommendations.

Imugen, Inc. is a privately held Reference Diagnostic Laboratory located in Norwood, MA. Imugen is nationally recognized as the leading reference laboratory for tick-borne diseases and an industry leader in pioneering research and development of highly specialized testing for tick-borne and other diseases. Imugen utilizes methodology for diagnosing Lyme disease based on a combination of technologies.

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Editor: Susan K. Boyer, RN
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