Enzo Biochem Launches Proprietary Test for Detection of Coronavirus SARS-CoV-2 IgG Antibody Under FDA’s Emergency Use Authorization
Second Product Offering to Expand Disease Management within Enzo’s Comprehensive COVID-19 Program
Enzo’s ELISA Kit for SARS-CoV-2 IgG Antibody Demonstrates High Specificity and High Sensitivity Detection
NEW YORK, NY, May 20, 2020 (GLOBE NEWSWIRE) -- 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.
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 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.
For Enzo Biochem, Inc.
David Bench, CFO
The Blueshirt Group
Anreder & Company