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New York State Grants Approval of IGeneX's Newly Developed Lyme ImmunoBlot Tests

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Lyme ImmunoBlots (IgM and IgG) represents quantum leap in test
performance over the traditional B. burgdorferi Western blots.

The Division of Laboratories of the Department of Health of the State of
New York has approved IGeneX's newly developed Lyme ImmunoBlots (IgM and
IgG), making it immediately available to New York practitioners.

Now, instead of sourcing test antigens from only one or two species of
sonicated Borrelia, the ImmunoBlot is comprised of specific
recombinant antigens from several species of Borrelia burgdorferi.
The ImmunoBlot therefore detects the following US and European species
of Lyme Borrelia: B. burgdorferi B31, B. burgdorferi 297, B. mayonii,
B. spielmanii, B. californiensis, B. valaisiana, B. afzelii and B.
garinii
and makes the P31 epitope confirmation test unnecessary.

To test for all the above Borrelia burgdorferi species by Western
blots, eight individual IgM and eight individual IgG tests are required.
Performing 16 Western blots on each patient sample is expensive and
impractical as opposed to just two tests with the Lyme ImmunoBlots.

"The Lyme ImmunoBlot is intentionally more inclusive for Borrelia
burgdorferi sensu lato
than the currently available Western blots
because we now know that other species such as B. mayonii, B.
californiensis
and B. spielmanii all cause disease in the
US," said Dr. Jyotsna Shah, CEO of IGeneX. "With the increase of
international travel in the last 10 years, people can get infected at
home, other parts of the US or Europe depending on their lifestyle.
Thus, it is important to have available a test that can detect the
infection irrespective of where it was acquired."

More Comprehensive Detection

The Lyme ImmunoBlot IgM detects the five following recombinant protein
groups: P93, P41, P39, P31, and P23. Furthermore, the Lyme ImmunoBlot
IgG detects these twelve recombinant protein groups: P93, P66, P58, P45,
P41, P39, P34, P31, P30, P28, P23, and P18.

High Accuracy Across the Disease Spectrum

The accuracy of the Lyme ImmunoBlot has been established by exhaustive
testing. The sensitivity with well-characterized samples has been shown
to be greater than 93% whereas the two- tier testing recommended by CDC
has a sensitivity of about 57.6% (Waddell LA et al. PLoS
ONE
. 2016;11(12):e0168613. doi:10.1371/journal.pone.0168613).
Additionally, the ImmunoBlots detect the full spectrum of disease:
early, active and late-stage disease. This high degree of sensitivity
does not come at the cost of specificity. The specificity of the Lyme
immunoblot is equivalent to CDC 2-tier testing (ELISA or IFA followed by
Western blots).

New York State Department of Health Approval

The Clinical Laboratory Evaluation Program, Wadsworth Center, New York
State Department of Health has approved the IGeneX Lyme ImmunoBlot (https://www.wadsworth.org/igenex-inc-reference-laboratory-12),
making it available to all qualified New York practitioners and their
patients. IGeneX works swiftly to ensure that this remarkable test can
be utilized immediately.

The Wadsworth Center, a division of New York State Department of Health,
is a science-based community committed to protecting and improving the
health of New Yorkers through laboratory analysis, investigations, and
research, as well as laboratory certification and educational programs.
The Center serves a vital role in the New York State Department of
Health's efforts to protect and promote the health of New York's
citizens.

About IGeneX

For over 25 years, IGeneX has been at the forefront of research and
development of diagnostic testing for Lyme disease, Relapsing Fever, and
other tick-borne diseases. IGeneX arms its talented scientists with the
most cutting-edge technology available to enable them in finding new
solutions that challenge the status quo of testing for Lyme and
associated tick-borne diseases. This team of experienced, hands-on
experts develops these tests in-house using a wider spectrum of relevant
proteins and strains that look for and detect more. The mission of
IGeneX is to aid practitioners in their diagnosis of tick-borne
illnesses by providing the most comprehensive testing possible. Learn
more at: www. IGeneX.com

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