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
"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.