New York State Department of Health Approves
Tests on GenFlex Platform, Enzo Biochem’s First Commercially
Available High-Throughput Open Platform
Approval of Gynecological Tests (CT/NG/TV) on
GenFlex Platform Represents Sea-Change in Providing Cost-Effective
Comprehensive Menu of Molecular Diagnostic Tests
Genflex addresses the $450 million annualized
global CT/NG/TV diagnostic market as well as the $1.3 billion
Women’s Health market
Further Validation of Company’s Ability to
Leverage Leading Intellectual Property
Enzo Biochem, Inc. (NYSE: ENZ) today announced that its wholly
owned subsidiary, Enzo Clinical Labs, Inc. has received New York
State approval for its CT/NG/TV tests using liquid-based cytology
sample collection on its proprietary GenFlex platform. GenFlex is a
commercially available sample-to-result molecular diagnostic
platform that includes sample collection, sample processing,
amplification and detection. The GenFlex open system delivers
high-throughput, high capacity, workflow efficiency and flexibility
at a much greater level of affordability than existing systems.
This is the latest successful development in Enzo’s strategic
plan to provide a cost-effective, comprehensive menu of molecular
diagnostic products and services. This significant milestone
achievement highlights Enzo’s continued ability to deliver high
performance, open, flexible, adaptable and cost-effective products,
devices and services. Compared favorably to all other proprietary
platforms dominating the diagnostic testing market, Enzo’s GenFlex
platform offers 30-50% cost-savings over current closed
systems.
GenFlex addresses the $450 million annualized global CT/NG/TV
diagnostic market as well as the $1.3 billion Women’s health
market. Extensions of the Genflex platform, which Enzo is currently
developing, could eventually address the entire $7 billion
molecular diagnostic market.
Enzo CEO Dr. Elazar Rabbani commented, “We are extremely pleased
to announce this approval of GenFlex as we remain on track on our
development program. Enzo’s previously validated Ampiprobe
detection system has been transformed into a complete end-to-end
solution, GenFlex. This platform is a direct response to the
critical industry need to offer lower cost solutions in the
dramatically shrinking reimbursement rate environment as we can now
offer users cost savings of 30-50% and the scalability necessary
for a full commercial roll out. In fact, GenFlex’s robust platform
is being expanded beyond CT/NG/TV to a vast menu of tests within
molecular diagnostics including sexually transmitted diseases, a
category that is rising exponentially in both men and women in all
sites of the body, including anal, oral and cervical-vaginal
sites.”
Barry Weiner, President of Enzo, said “This New York State
approval is transformative as we now evolve from having the tests
to having a validated entire end-to-end solution to run a series of
tests without users being tied to existing closed systems. We know
that the affordability of Enzo’s testing on GenFlex makes it
possible to deliver clinical results to other medical
establishments. The pathway to commercialization is clear.”
According to the Centers for Disease Control and Prevention
(CDC), there are more than 1.7 million cases of Chlamydia (CT),
500,000 cases of Neisseria Gonorrhea (NG) and 3.7 million cases of
Trichomonas Vaginalis (TV) in the United States per annum.
The approval of the GenFlex platform is directly related to the
successful development work completed on Enzo’s proprietary
Ampiprobe detection technology which was initially validated on
third-party research-only instrumentation. GenFlex overcomes
challenges inherent in existing platforms which may include: the
extraction system necessitating expensive sample processing
reagents, multi-year provider contracts, low-capacity throughput,
and multiple independent instruments for extraction, PCR set-up,
and detection.
Adopting Ampiprobe detection technology into third-party
platforms was a necessary first step towards Enzo’s development of
a fully automated system. However, with Enzo’s GenFlex approval,
Enzo’s goal of commercializing a fully automated high-throughput
platform with 30-50% cost savings is being realized.
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.
Important Additional Information and Where
to Find It
Enzo Biochem, Inc. (the “Company”) has filed and mailed to
shareholders a definitive proxy statement and proxy supplement on
Schedule 14A and accompanying WHITE
proxy card with the Securities and Exchange Commission (the “SEC”)
in connection with the solicitation of proxies from the Company’s
shareholders with respect to its 2019 Annual Meeting of
Shareholders. The Company has filed in preliminary form and intends
to file and mail to shareholders a new definitive proxy supplement
and new GOLD proxy card. Shareholders
are strongly encouraged to read the Company’s proxy statement,
proxy supplements, accompanying GOLD
proxy card and all other documents filed with the SEC as they
become available carefully and in their entirety as they contain
important information.
Certain Information Regarding Participants
to the Solicitation
The Company, its directors and certain of its executive officers
are participants in the solicitation of proxies from shareholders
in connection with the Company’s 2019 Annual Meeting of
Shareholders. Information regarding the direct and indirect
interests, by security holdings or otherwise of the Company’s
participants is set forth in the Company’s definitive proxy
statement and proxy supplement for the 2019 Annual Meeting of
Shareholders filed with the SEC on December 5, 2019 and December
31, 2019, respectively. The Company’s definitive proxy statement
and proxy supplement can be found on the SEC’s website at
www.sec.gov or the Company’s website
at http://www.enzo.com/corporate/investor-information.
Forward-Looking Statements
Except for historical information, the matters discussed in this
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, 2019. 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 release.
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version on businesswire.com: https://www.businesswire.com/news/home/20200211005483/en/
For: Enzo Biochem, Inc. David Bench, CFO 212-583-0136
dbench@enzo.com or ESPR LLC 917-291-0833 Elliot.espr@gmail.com
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