Enzo Biochem, Inc. (NYSE:ENZ) today announced that it has entered into
an agreement with MultiGEN Diagnostics Inc., of San Diego, California,
for exclusive rights to market MultiGEN’s unique diagnostic tests based
on multiplex DNA sequencing, in the state of New York. In addition, Enzo
has been granted marketing rights for other non-exclusive territories in
United States.
Enzo will validate and seek approval of an Antenatal Infectious Disease
panel as well as a thrombophilia panel pursuant to New York, New Jersey
and CLIA [Clinical Laboratory Improvement Act] requirements, in addition
to marketing, and securing third party reimbursement for the test. Terms
were not disclosed. Enzo said that subject to regulatory and
reimbursement approval, among others, it hopes to make the test
available in the second half of 2010.
The tests bolster Enzo’s already strong portfolio of women’s health
diagnostics. The antenatal panel allows for simultaneous identification
of certain bacterial viral or fungal pathogens in a single convenient
specimen. Additionally, the thrombophilia panel detects multiple
mutations that can diagnose genetic predisposition to blood clotting.
"In our continuing mission to develop and offer cutting edge esoteric
tests that provide our clients the best diagnostic tools that exist we
are pleased to announce this alliance with MultiGEN,” said Kevin
Krenitsky, M.D., President of Enzo Labs. "These particular tests utilize
true state of the art technology and offer physicians serving women
highly accurate and convenient options for improved patient service.”
"Enzo Clinical Labs innovative capabilities in developing tests in New
York State, combined with their existing commitment to offer world class
diagnostics in the women’s health arena make them the perfect partner
for us,” said T. Vinayagamoorthy, Ph.D., Founder and President of
MultiGEN Diagnostics. "MultiGEN has developed a truly novel next
generation multiplex sequencing technology that advances the accuracy
and utility of these diagnostic tests and we are very pleased to begin
offering them in Enzo’s highly populated geographical region. Early
feedback in the test markets from the physician community has been
extremely positive.”
About Enzo
Enzo Biochem, Inc., is a growth-oriented integrated life sciences and
biotechnology company focused on harnessing biological process to
develop research tools, diagnostics and therapeutics, and serves as a
provider of both routine and esoteric test services to the medical
community. Since its founding in 1976, the Company’s strategic focus has
been on the development of enabling technologies in the life sciences
field. Enzo Life Sciences develops, produces and markets proprietary
labeling and detection products for gene expression analysis, nucleic
acid detection, protein biochemistry, and cellular analysis, among
others. Its catalog of over 40,000 products serve the molecular
biology, cellular biochemistry, drug discovery and pathology research
markets worldwide. Enzo Clinical Labs division provides laboratory
services for a growing roster of physicians in the New York Metropolitan
area, as well as New Jersey and parts of Pennsylvania. Its tests
include, in addition to routine tests, capabilities for detecting
molecular infectious disease, molecular oncology, autoimmune disorders
and genetics. Enzo Clinical Labs also provides clinical diagnostic
services that allow Enzo to capitalize on its extensive advanced
molecular and cytogenetic capabilities and the broader trends in
predictive and personalized diagnostics. Enzo Therapeutics is a
biopharmaceutical venture that has developed multiple novel approaches
in the areas of gastrointestinal, infectious, ophthalmic and metabolic
diseases. It has focused its efforts on developing treatment regimens
for diseases and conditions for which current treatment options are
ineffective, costly, and/or cause unwanted side effects. In the course
of the company’s research and development activities, Enzo has developed
a substantial portfolio of intellectual property assets, with over 240
issued patents worldwide and more than 200 pending patent applications.
About MultiGEN
MultiGEN is an emerging molecular diagnostic company focused on DNA
sequence based identification. Their unique platform technology is
patent protected in the USA and internationally. MultiGEN is a novel
modification of the well-documented ‘Gold-Standard’ DNAsequencing
(Sanger method). This modification enables simultaneous identification
of multiple pathogens regardless of whether they are bacteria, viruses,
fungi or parasites. This capability allows a single drop of blood, for
example, to be tested for a wide spectrum of organisms. This unique
advantage dramatically reduces the cost per reported organism. Hence for
the first time, DNA sequencing is made economical for routine testing.
Other clinical applications include testing for genetic predisposition
and cancer markers. The Company has a pipeline of assays that are at
various stages of development. MultiGEN panel assays avoid physicians
collecting multiple samples. In addition to having the most accurate and
verifiable results, physicians can have the results within the same day
for improved patient management. The Company operates a CLIA approved
and CAP certified laboratory in San Diego, California, USA. MultiGEN has
published in several peer-reviewed medical journals and is recognized by
international health care institutions such as the WHO (World Health
Organization).
Except for historical information, the matters discussed in this news
release may be considered "forward-looking" statements within the
meaning of Section 27A of the Securities Act of 1933, as amended and
Section 21E of the Securities Exchange Act of 1934, as amended. Such
statements include declarations regarding the intent, belief or current
expectations of the Company and its management. Investors are cautioned
that any such forward-looking statements are not guarantees of future
performance and involve a number of risks and uncertainties that could
materially affect actual results. The Company disclaims any obligations
to update any forward-looking statement as a result of developments
occurring after the date of this press release.
