Life Science News

NEW YORK–(BUSINESS WIRE)–Enzo Biochem, Inc. (NYSE:ENZ) today announced that the New York State Department of Health has granted conditional approval for use of Enzo Clinical Labs’ AmpiProbe Candidiasis™ assay, the Company’s second test aimed at the rapidly expanding women’s health market and the third to be approved utilizing one of the Company’s proprietary technology platforms. …

NEW YORK–(BUSINESS WIRE)–Enzo Biochem, Inc. (NYSE:ENZ) today announced that the New York State
Department of Health has granted conditional approval for use of Enzo
Clinical Labs’ AmpiProbe Candidiasis™ assay, the Company’s second test
aimed at the rapidly expanding women’s health market and the third to be
approved utilizing one of the Company’s proprietary technology platforms.
Elazar Rabbani, Ph.D., Enzo CEO and Chairman, commented that the Candida
approval, while important in and of itself, and having been approved
less than three months after submission, “strengthens our commitment to
utilize our proprietary technologies to develop clinically relevant
diagnostics, while helping to relieve the cost pressures that
independent laboratories are bearing. It underscores the progress we are
achieving in our strategy of utilizing Enzo’s integrated structure to
produce diagnostic products and services relevant to today’s dynamic and
challenging healthcare marketplace.”
Dr. Rabbani added that by developing a broad technology base, Enzo has
positioned the Company for a robust flow of products and services that
will provide medically relevant, cost effective solutions easily
adaptable to the workflow of the clinical laboratory, and that its
ability to do so is based on several factors, including:

  • The Company’s integrated structure that enables it to internally
    develop and advance products seamlessly from innovation through
    commercialization validation via recent patent settlements of Enzo’s
    intellectual property strength and ownership of basic patents that
    provide an economic advantage
  • In a steadily declining reimbursement environment the unique ability
    to deliver high performance, easily adaptable products and services
    that are also meaningfully cost effective for independent labs as well
    as Enzo’s own clinical lab
  • Ample finances with which to execute and follow through on the
    Company’s integrated strategy.

AmpiProbe Candidiasis™ is a multiplex assay designed to identify the
presence of five of the most common species of Candida from a single
vaginal swab. Industry estimates put the number of tests performed for
the identification of Candida at over 10 million per year in the US
alone. It is also estimated that over 70% of women will develop a
Candida infection during their reproductive lifetime. While an
independent assay, it will also serve as a component of a comprehensive
women’s health panel currently under development. Additionally, Enzo
scientists will deliver a technical presentation at the College of
American Pathologists (CAP) annual meeting this September.
The approval of AmpiProbe Candidiasis follows a similar approval granted
to Enzo last November by the New York State Department of Health of AmpiProbe
HCV ™
for the quantitative detection of hepatitis C virus and prior
to that, Enzo’s FlowScript™ HPV assay. The FlowScript assay, approved in
February 2015, is based on proprietary technology allowing the
multiplexed analysis of cellular function in a single assay via the
simultaneous examination of each and every cell in a given sample. It is
now being used to assist physicians in better evaluating the progression
of abnormal pap smears toward cervical cancer. These assays are now
being offered by Enzo Clinical Labs to physicians, and also are
currently being marketed nationwide, as will AmpiProbe Candidiasis™.
Enzo’s proprietary platforms and the assays developed based on them can
provide more sensitive diagnostic information at lower costs than many
other tests currently marketed. The Company designs its products to be
able to work with lower specimen volume which not only allows the
laboratories to run more tests off of a single clinical specimen, but
also reduces the need for patients to submit additional samples, thus
reducing unnecessary physician visits. The newly approved assays are the
forerunners of a comprehensive line of diagnostic products under
development by Enzo to address the critical needs of clinical
laboratories that are often locked into closed-system contracts with
molecular diagnostic suppliers that, with ever-declining reimbursements,
reduce or even eliminate operating margins.
Products in the Company’s development pipeline include an extensive line
of assays for detection of numerous women’s health infectious agents as
well as for use in the identification of pathogens for other markets.
The Company also reported that it expects to roll-out a line of products
designed to aid pathologists in distinguishing the characteristics of
various tumors from biopsy specimens using technology developed by Enzo
scientists. The Company’s molecular-based products are targeted at a
market estimated to be in excess of $3 billion worth of laboratory
service revenue.
About
Enzo Biochem

Enzo Biochem is a pioneer in molecular diagnostics, leading the
convergence of clinical laboratories, life sciences and intellectual
property through the development of unique diagnostic platform
technologies that provide numerous advantages over previous standards. A
global company, Enzo Biochem utilizes cross-functional teams to develop
and deploy products systems and services that meet the ever-changing and
rapidly growing needs of health care both today and into the future.
Underpinning Enzo Biochem’s products and technologies is a broad and
deep intellectual property portfolio, with patent coverage across a
number of key enabling technologies.
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, including those related
to cash flow, gross margins, revenues, and expenses are dependent on a
number of factors outside of the control of the company including, inter
alia, the markets for the Company’s products and services, costs of
goods and services, other expenses, government regulations, litigations,
and general business conditions. See Risk Factors in the Company’s Form
10-K for the fiscal year ended July 31, 2015. 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.

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