New York State Health Department Approval of
Oral and Rectal STI Testing
Enzo to Create Direct to Consumer Testing
Business for Sexually Transmitted Infections
Also, Building a New Model for Lab-to-Labs
Diagnostic Testing Business, and Expanding Offerings to CRO’s,
Academic Research and Pharmaceutical Industry
Enzo Biochem, Inc. (NYSE: ENZ) today announced several key
transformative initiatives in its labs business unit designed to
propel and accelerate growth. The initiatives are part of a
company-wide commitment to expand its market opportunity in
diagnostic testing, capitalizing on Enzo’s history of innovation,
differentiated business strategy and emerging market dynamics.
The three key initiatives are:
1.
New York State Health Department Approval for Gonorrhea and
Chlamydia Tests for Oral and Rectal Specimens; Creates
Direct to Consumer Testing Business for Sexually Transmitted
Infections (STIs)
Enzo, a recognized market leader in the development of
diagnostic molecular testing for a wide range of sexually
transmitted diseases, recently won New York State Health Department
approval for use of its AmpiProbe® Neisseria gonorrhoeae (NG) and
Chlamydia trachomatis (CT) DNA tests with oral (pharangeal) and
rectal specimens. This expands Enzo’s menu, allowing the Company to
provide one of the most comprehensive panels for STI testing for
not only women but also men, who represent a rapidly growing
segment for such testing.
Over the last decade, the nature of pathogens and the sites of
infection have undergone significant changes due to the changing
sexual behaviors in the broader population. For example, although
the presence of viruses such as HPV are commonly tested in the
female population as part of the Women’s Health Panel, HPV is
substantially found in the male population, where the Center for
Communicable Diseases (“CDC”) estimates that almost 50% of the male
population aged 18-60 have a genital HPV infection. Changes in the
sites of infection are also reflected in population statistics
where the focus on the association with cervical cancer is being
overtaken by increases in oral and anal cancers associated with
HPV. In 2017, according to CDC, 11 million men and 3.2 million
women tested positive for oral HPV infections, underscoring the
disproportionate growth in infections among men.
Enzo’s comprehensive AmpiProbe® Sexually Transmitted Infection
Panel, which has already been approved by New York State, is a
multiplex nucleic acid amplification test that can detect 16 common
sexually transmitted diseases including Candida, Chlamydia
trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis,
Ureaplasma, Mycoplasma, and Bacterial Vaginosis (BV) using a single
collection swab. With this latest approval, Enzo now provides
expanded specimen collection options from multiple relevant body
sites for NG and CT testing.
Enzo also provides testing from both anal and genital specimens
for HPV (Human Papilloma Virus), a sexually transmitted virus
associated with the development of cancer, as well as tests for
other sexually transmitted diseases, including HIV and Herpes
Simplex Virus (HSV). The Company is also developing an application
for the detection of HPV from oral specimens of both men and women.
Enzo’s STI and women’s health related pathogen testing menu
addresses three important health contexts - diagnosis of infection
and other general health issues, control of transmission, and
infection risk at birth.
“Given our market position in diagnostic testing in STIs and the
urgent and growing demand for these tests in particular
populations, we believe the time is right to launch a
direct-to-consumer testing application where, in permitted
jurisdictions, patients can avail themselves of these tests simply
and effectively, with privacy, but without the unnecessary red tape
and oversight of insurance carriers and shifting reimbursement
policies. We are working with a number of medical professionals,
urgent care facilities and other intermediaries to launch this
business this fiscal year. We will offer a comprehensive series of
all STI molecular tests across all relevant sites of infection as a
complete package of services. Initial response has been very strong
due to our comprehensive menu, ability to provide privacy, and cost
effective approach. We believe this business model and expansion of
our product line has significant potential,” said Barry Weiner,
President and Chief Financial Officer of Enzo.
2.
Building a New Model for the Diagnostic, Lab to Labs
Marketplace
As previously stated in the recent 2Q19 earnings announcement,
Enzo is rolling out a new lab-to-labs business model. With it, Enzo
will serve as the “central capability” for smaller labs,
capitalizing on the Company’s scale in high value and lower cost
operations, proprietary intellectual property and products, decades
of innovation and commitment to medical solutions.
“We continue to be very energized by this growth initiative,”
continued Mr. Weiner. “We see immense opportunity in expanding the
market for diagnostic testing and offering labs the ability to
serve their customers in a cost effective and collaborative model.
This business model is predicated on our foundational approach to
innovation, to science, to manufacturing and to cost-efficient
product development. We remain on track to announce our first
partners in this program by the end of calendar 2019.”
3.
Expanding Offerings to CRO’s Academic Research Institutions
and the Pharmaceutical Industry
Identifying and capitalizing on another important market niche,
Enzo is expanding its service offerings to clinical research
organizations (CRO’s), academic research institutions, and the
pharmaceutical industry. Over the next few months, Enzo plans to
rapidly extend these services to a broader array of customers, who
can benefit from the depth of science as well as the scale and
scope of Enzo’s diagnostic lab.
This area of focus is a natural extension of Enzo’s clinical lab
capabilities. Large organizations today not only require speed and
scale, but also cost-effectiveness in testing. Enzo is the ideal
provider of solutions for institutions looking to outsource their
testing. Enzo hopes to have meaningful updates to announce over the
course of the next six months as it ramps up marketing and
discussions with current and prospective customers.
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 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, 2018. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190711005194/en/
For: Enzo Biochem, Inc. Steve Anreder, 212-532-3232
steven.anreder@anreder.com or Michael Wachs, CEOcast, Inc.,
212-732-4300 mwachs@ceocast.com
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