Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV-2 IgG Antibody Under FDA’s Emergency Use Autho...
May 20 2020 - 7:00AM
Enzo Biochem, Inc. (NYSE:ENZ), a leading biosciences and
diagnostics company, today announced that it is currently offering
a SARS-CoV-2 IgG ELISA assay kit for serological detection of
IgG antibodies against the novel coronavirus under the FDA’s
Emergency Use Authorization (EUA) authority as both products and
services. While molecular tests detect the presence of viral RNA to
diagnose active infection, serological tests are used to detect the
presence of antibodies to the SARS-CoV-2 virus. The emphasis in the
coming months is shifting towards mass-market serological testing
to determine if individuals were previously exposed to the novel
coronavirus and are likely to have already recovered from
infection. Accordingly, it is believed that serological testing
will play an important role in enabling the workforce to return to
their places of employment.
The assay permits the qualitative detection of IgG antibodies to
SARS-CoV-2 in human serum and is designed to provide accurate
results in a clinical laboratory setting with low- to
high-throughput processing of specimens. In a clinical study,
performance of the SARS-CoV-2 ELISA Kit was compared with a
molecular diagnosis (PCR) using serum samples from approximately
150 individuals. Positive percent agreement (PPA) and negative
percent agreement (NPA) with a comparator PCR observed 96.5%
specificity and 100% sensitivity. Clinical assays for antibodies
must be reliable and have high specificity without cross-reactivity
to related viruses.
These new serological tests, which are built on Enzo’s
proprietary ELISA platform, work with serum specimens and are
formatted for both manual test processing situations as well as
automated, high-throughput clinical workflows. Enzyme-linked
immunosorbent assay (ELISA) is an analytical, plate-based technique
to detect the presence of a target analyte in a liquid sample using
affinity reagents. The Immunoglobulin G (IgG) Antibody Kit detects
IgG antibodies specific for SARS-CoV-2 to identify individuals
previously exposed to and infected by the coronavirus, even if they
have never displayed symptoms.
“Serological testing will play a critical role in identifying
individuals who are transitioning to post-infection status and have
developed an immune response. While some competitor assays detect
total immunoglobulin with no differentiation between immunoglobulin
types, Enzo’s serological assays differentiate between these
immunoglobulin types, thereby providing more information to
clinicians for determining particular stages of infection,” said
Dr. Elazar Rabbani, Enzo CEO. “As with the launch of Enzo’s
molecular test for the detection of active coronavirus infection,
our serological assay test kit will be available for purchase by
other clinical labs and is being used to perform serological
testing at Enzo’s own CLIA-certified laboratory.”
Enzo’s high-throughput kit for IgG antibody utilizes a routine
blood collection at a lab’s patient service center, a doctor’s
office, or a hospital. The sample is then sent to the clinical
laboratory for processing and analysis. This workflow permits
scalable testing to be performed under controlled conditions to
deliver accurate and sensitive results. Enzo’s proprietary 96-well
ELISA based technology is readily scalable to meet the needs of the
clinical laboratory environment, while providing reliable and
economical results. All kits are manufactured at Enzo’s GMP
certified production facilities.
Enzo previously published a white paper detailing its
Comprehensive COVID-19 Program and recently published a more
specific white paper detailing its COVID-19 Antibody Screening
Program.
Both white papers are available on Enzo’s website at:
https://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.
###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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