Authorization Enables Clinical Labs to Purchase and Use Enzo’s AMPIPROBE® SARS-Cov-2 Test System without Further Validation
Flexible Use on Three Platforms including Enzo’s Proprietary Automated GENFLEX™ Platform
NEW YORK, NY, July 13, 2020 – 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.
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.