First Test Offering Within Enzo’s
Comprehensive COVID-19 Program
Proprietary Molecular Diagnostic Kits Offer
Improved Scale, Throughput, and Sensitivity
Enzo Biochem, Inc. (NYSE:ENZ), a leading biosciences and
diagnostic company, today announced its Comprehensive COVID-19
Program incorporating its molecular diagnostic virus screening
products, detection for immunity through IgG/IgM serological ELISA
products, detection of inflammation on Enzo’s ELISA platform, and a
promising proprietary drug candidate (SK1-I). Enzo is utilizing its
technological and research and development capabilities,
manufacturing infrastructure strength and clinical diagnostic
capabilities to provide products that address gaps in performance,
cost, supply obtainability and safety. Most diagnostic platforms
offered by others are ‘closed’ systems and have no flexibility with
regards to adoptability for other infectious agents, have limited
supplier relationships, and have no direct connection with the
patient or the event. These underlying problems have manifested
themselves in the current COVID-19 crisis. Enzo’s Comprehensive
COVID-19 Program showcases Enzo’s ability to respond to the current
challenges plaguing the healthcare market.
Enzo’s Diagnostics division is currently offering
next-generation COVID-19 test kits under the FDA’s Emergency Use
Authorization (EUA) authority. The tests, which use Enzo’s
proprietary GENFLEX™ open diagnostic platform, include a collection
system, sample processing and molecular analytic products that
address and circumvent the supply shortfalls throughout the
diagnostic market.
“Enzo is uniquely positioned to address the COVID-19 pandemic
from multiple angles. We have an open molecular diagnostic system
with complete capabilities from sample collection to processing,
detection, and analytics. Our open system allows for adoptability
with regards to reagents, supplies, and instruments. This system
can be used for the current COVID-19 crisis, and furthermore it can
be repurposed for any current or future infectious agent diagnosis.
Our solutions are available as full system product sales or as
individual components,” said Dr. Elazar Rabbani, Enzo CEO. “We have
launched this platform, now available for purchase, and are also
processing tests at our CLIA laboratory, where we have current
capacity of 2,000 COVID-19 molecular tests per day and can expand
to meet market demand.”
Leveraging Enzo’s expertise in diagnostics technology, the new
COVID-19 test features improved scale, sensitivity, and more
relevant positive control materials. Enzo’s control, RNAseP,
confirms the presence of human mucosa cells in the specimen,
verifying accurate collections. The RNA positive control closely
resembles in vivo conditions. Enzo consulted with the U.S. Centers
for Disease Control and Prevention on the implementation of these
enhanced test features.
The well-publicized supply chain shortage of swabs, reagents,
and other collection materials, compounded by the limited sample
processing and molecular analytic capabilities available, has
created a national crisis. There are approximately 835,000
confirmed cases of coronavirus in the United States and nearly 2.6
million worldwide. However, experts estimate that a more accurate
count could be much higher. Widespread testing is needed to obtain
a more reliable estimate, learn the virus’s behavior, and properly
manage its spread. Testing just 10% of the U.S. population only
once would require 33 million tests. Furthermore, serial testing
should be provided to those who have previously tested positive and
to people who are regularly exposed to the virus, such as
healthcare providers and emergency personnel. Any attempt to reopen
the economy requires the ability to distinguish between infected,
recovered, and non-infected individuals from within the total
population. An improved test would be both widely available and
allow for future self-collection by the patient, thereby reducing
the risk to clinical workers.
Enzo’s GENFLEX™ Molecular Diagnostic Modular System (for
SARS-CoV-2 Detection) includes the following components currently
available or under development:
- AMPICOLLECT™ Sample Collection Kit - a proprietary sample
collection kit to overcome supply limitations and enable patient
self-testing (IN CLINICAL TRIALS)
- AMPIXTRACT™ Sample Preparation (Genetic Extraction from Patient
Sample) (AVAILABLE)
- GENFLEX™ Automated Instrument for Sample Processing
(AVAILABLE)
- AMPIPROBE® Amplification and Detection (AVAILABLE)
Enzo’s solution includes a complete molecular diagnostic kit
optimized for use on the proprietary GENFLEX™ molecular diagnostics
platform and compatible with manual or alternative platforms.
GENFLEX™ is Enzo’s high-throughput, sample-to-result platform that
delivers high capacity, efficiency, and flexibility at a lower
price point than existing systems. The GENFLEX™ and manual kits are
now available.
In addition, as part of Enzo’s Comprehensive COVID-19 Program,
the Company is developing the following:
- IgG/IgM Antibody Test (for Immunity Detection) -
Immunoglobulin G (IgG) / Immunoglobulin M (IgM) on an ELISA
(enzyme-linked immunosorbent assay) plate for detecting and
quantifying antibodies to identify the individuals who were
infected with, or without, symptoms
- Cytokine Storm Immunoassay (for Inflammation Monitoring)
- Commercialization of Enzo’s full inflammation panel including
the detection of Interleukin 6 (IL-6) levels (currently available
for Research Use Only) to enable administration of
immunosuppressant to treat Coronavirus when a patient demonstrates
a hyper immune response
- Potential Use of Enzo's Drug Candidate SK1-I (for the
Prevention and/or Treatment of Cytokine Release Syndrome and
Respiratory Failure in COVID-19 Patients) - Therapeutic studies
based on a promising proprietary drug candidate (SK1-I) which may
have potential in the treatment of COVID-19 as it has already
demonstrated immunosuppressant response in a recognized,
chemically-induced animal model of Lupus and has previously passed
preliminary toxicology studies.
Enzo’s Comprehensive COVID-19 Program showcases Enzo’s ability
to respond to the current challenges plaguing the healthcare
market. The company’s integrated structure gives Enzo the advantage
of having direct access to patients while keeping control of the
testing reagents and supply chain. Enzo’s full system open platform
solutions make flexibility, affordability and quality available to
a market that currently lacks these needed conditions.
Enzo has published a white paper detailing this program which is
available on Enzo’s website at:
http://www.enzo.com/coronavirus.
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.
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/20200423005188/en/
For: Enzo Biochem, Inc. David Bench, CFO 212-583-0100
dbench@enzo.com Investors/Media: Melanie Solomon The Blueshirt
Group 415-217-4964 melanie@blueshirtgroup.com Steve Anreder Anreder
& Company 212-532-3232 Steven.anreder@anreder.com
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