Enzo Biochem Receives Emergency Use Authorization for Proprietary Test System for Detection of Coronavirus SARS-CoV-2
July 13 2020 - 8:30AM
Enzo Biochem, Inc. (NYSE:ENZ), a leading biosciences and
diagnostics company, today announced that it has formally received
Emergency Use Authorization (EUA) for its proprietary product for
the detection of Coronavirus SARS-CoV-2. The Authorization enables
other laboratories to use Enzo’s products with three diverse
platforms without requiring further validation. These platforms
include Enzo’s proprietary GENFLEX™ automated high-throughput
platform, Qiagen’s QIAsymphony® SP lower-throughput platform and
Enzo’s manual workflow. The AMPIPROBE® SARS-Cov-2 Test System
includes three components: sample collection, AMPIXTRACT™
SARS-CoV-2 Extraction Kit for sample processing, and the AMPIPROBE®
SARS-CoV-2 Assay Kit for detection and analysis.
In its letter of authorization dated July 7, 2020, the FDA
stated: “The above described product, when accompanied by the
instructions for use and the two fact sheets (collectively
referenced as “authorized labeling”), is authorized to be
distributed and used by authorized laboratories under this
EUA.”
“This is an important milestone for Enzo as the FDA’s EUA on
three disparate systems demonstrates the flexibility and
adaptability of our highly reliable and sensitive PCR-based
molecular test for SARS-Cov-2,” said Elazar Rabbani, Ph.D., Enzo
CEO. “The EUA builds upon our comprehensive COVID-19 program and
the diagnostic testing efforts we first announced in April, which
have already garnered significant interest from government
entities, nursing homes, and universities as they plan testing
programs for their constituents.”
Leveraging Enzo’s expertise in diagnostics technology, the
AMPIPROBE® SARS-Cov-2 Test System features improved scale, high
sensitivity, particularly relevant positive controls comprising in
vitro transcribed viral RNA, and RNaseP as an internal control to
confirm the quality of the specimen collection and the nucleic acid
extraction process.
Pursuant to receiving the Emergency Use Authorization, Enzo’s
diagnostics division is offering the AMPIPROBE® SARS-Cov-2 Test
System for use with three platforms. The first platform is Enzo’s
proprietary automated GENFLEXTM platform, which is a
high-throughput, sample-to-result open molecular diagnostics system
that delivers high capacity, efficiency, and flexibility at a lower
price point than competing systems. The second platform is for the
use of Enzo’s proprietary test for detection and analysis in
conjunction with nucleic acid extraction on the QIAsymphony® SP
platform. Lastly, the FDA authorized the use of Enzo’s proprietary
test on a manual workflow.
Enzo’s products are intended to address the capacity and supply
limitations that have arisen in the diagnostics market during the
COVID-19 pandemic. Enzo manufactures its own sample collection,
sample processing, and analytics products and supplies at its
GMP-certified facilities.
A new white paper titled “Enzo’s Emergency Use Authorized
AMPIPROBE® SARS-CoV-2 Test System” is currently available on its
website at https://www.enzo.com/coronavirus, along with two
previously published white papers detailing Enzo’s COVID-19 Product
and Platform.
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.
Contact:
For Enzo Biochem, Inc.
David Bench, CFO 212-583-0100 dbench@enzo.com
Investors/Media:
Melanie SolomonThe Blueshirt
Group415-217-4964melanie@blueshirtgroup.com
Steve AnrederAnreder &
Company212-532-3232Steven.anreder@anreder.com
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