Enzo Biochem Announces NYS Department of Health’s Approval of a New Women’s Health Infectious Disease Panel
October 23 2017 - 8:30AM
Business Wire
Provides the Ability to Diagnose up to 13
Different Female Infections from a Single Swab Sample Combined with
Enzo’s Other Approved Panels
Furthers Enzo’s Development Program of
Robust, Medically Relevant & Affordable Molecular
Diagnostic Products and Services Addressing the Clinical Lab
Industry’s Financial Pressures
Enzo Biochem Inc. (NYSE:ENZ) today announced it has received
approval of another women’s health infectious disease diagnostic
panel, which when combined with the Company’s previously approved
panels, makes for one of the most comprehensive, efficient and
affordable diagnostic products and services on the market today. A
variety of infections, including sexually transmitted ones, are
detected from a single vaginal swab collection via the Company’s
proprietary, versatile and cost-effective AMPIPROBE® platform. The
announcement results from recent action by the New York State
Department of Health granting conditional approval of the new
panel’s 5 additional tests, complementing the already approved 8
infectious disease tests for a total of 13 organisms being
detectable from a single vaginal swab specimen.
Enzo’s expanding women’s infectious disease menu complements and
continues Enzo’s decades long offering of women’s health tests
including a focused cancer offering. In the early 1980s, Enzo
brought the first in situ HPV cervical cancer detection system to
the marketplace. Enzo’s offerings have grown to include
immunohistochemistry and gene expression platforms for detecting
women’s cancers. The latest infectious disease panel follows
previously approved AmpiProbe® real time amplification detection
tests for qualitative detection of diseases such as Chlamydia
trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis and
Candida spp (C. albicans, C. glabrata, C. krusei, C. parapsilosis,
C. tropicalis). The newly approved tests for bacterial vaginosis
(BV), including Atopobium vaginae, Gardnerella vaginalis,
Lactobacillus spp, Megasphera spp and BVAB2, will now make Enzo’s
women’s health panel one of the most comprehensive on the
market.
Because of the panel’s comprehensiveness and high sensitivity,
it quickly and conveniently provides doctors and patients with a
result. Where previously a patient may have had to visit her
physician multiple times for multiple tests before a diagnosis was
reached, causing inconvenience and expense, this panel should
reduce those challenges.
Elazar Rabbani, PhD, Enzo Chairman and CEO said, “This
underscores that our extensive product and services pipeline is
moving along on schedule. We remain intently focused on developing
and offering highly effective and affordable diagnostic products
and services as solutions to the increasing financial pressures on
the clinical laboratory industry from both diminishing
reimbursements and the high cost of goods, particularly in the
molecular diagnostic arena.”
Dr. Rabbani added that, “Since Enzo’s inception, we have been
committed to advancing healthcare, and providing affordable and
reliable diagnostic testing. Enzo is uniquely able to target its
integrated diagnostic products and services corporate structure
which allows our Company to create cost-effective solutions for the
diagnostics market by a process involving technology development,
manufacturing, clinical validation and commercialization, while
also providing advanced state-of-the-art diagnostic laboratory and
reference services. The Company will continue to offer products and
services to the clinical laboratory industry at discounts from
prevailing market prices.”
Enzo’s development program includes a line of assays based on
its proprietary labelling and detection technologies for different
applications such as cancer, infectious disease and immunology. The
announcement today is the result of Enzo’s concerted use of its
proprietary AMPIPROBE® platform. The next AmpiProbe® based pipeline
panel under development will address the quantification of viral
load in serum or plasma specimens. With the Company’s
AmpiProbe-HCV® assay for the quantitative detection of Hepatitis C
virus already approved, and with the addition of AmpiProbe®
detection of Hepatitis B virus and HIV in development, that panel
is well on the way towards additional assays. The Company is also
developing a line of products designed to aid pathologists in
differentiating the characteristics of various tumors from biopsy
specimens. Also in the Company’s pipeline is a line of assays based
on its proprietary flow cytometry platform for diverse applications
in areas such as limitation cancer, immunology and infectious
disease. Moreover, many of the Company’s existing molecular
diagnostic tests can be extended, such as, for example, extending
the detection of vaginal HPV in women, to detecting HPV in oral and
anal locations in men and women. Enzo’s molecular-based products
and services target a domestic laboratory market currently
estimated to be in excess of $3 billion in revenues.
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
healthcare 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 which 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, litigation, and general business
conditions. See Risk Factors in the Company’s Form 10-K for the
fiscal year ended July 31, 2017. 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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version on businesswire.com: http://www.businesswire.com/news/home/20171023005375/en/
For: Enzo Biochem, Inc.Steve Anreder,
212-532-3232steven.anreder@anreder.comorCEOcast, Inc.Michael Wachs,
212-732-4300mwachs@ceocast.com
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