Results indicate that GENFLEX meets new FDA guidance calling for COVID-19 test developers to assess the impact of viral mutations on testing results
Company also publishes new corporate white paper outlining deficiencies in U.S. diagnostics sector’s response to COVID-19 and Enzo strategy results
NEW YORK, NY, March 02, 2021 (GLOBE NEWSWIRE) -- Enzo Biochem, Inc. (NYSE:ENZ) (“Enzo” or the “Company”), a leading biosciences and diagnostics company, today announced results of an analysis showing that tests processed on the Company’s proprietary GENFLEX™ molecular diagnostic platform are successfully able to detect the presence of currently known variants of COVID-19. While the Company’s PCR testing does not distinguish between different variants, positive samples can be further analyzed for variant identification. Rapid antigen tests currently available in the marketplace do not have this capability.
On February 22, 2021, the US Food and Drug Administration issued new guidance for SARS-CoV-2 test developers to evaluate the potential impact of viral mutations on currently available diagnostic tests. In the guidance, the agency recommended molecular diagnostic test developers design their tests to minimize the impact of viral mutations on test performance, routinely monitor for viral mutations that may impact test performance, and clearly convey any test limitations in the test's labeling. Enzo’s GENFLEX™ Molecular Test has been shown to meet this standard.
Enzo also recently published a new white paper analysis highlighting the key failures in the U.S. Diagnostics Sector’s response to the COVID-19 pandemic including challenges in development and delivery of accurate testing options, lack of scalability to meet demand, confusion about testing options and other areas. The paper, titled “COVID-19 Related Challenges in the U.S. Diagnostic Sector and Enzo’s Distinctive Response”, also outlines recommendations for broad structural changes to the diagnostics sector in the U.S. to position diagnostic companies and laboratories to better respond to global pandemics in the future.
“Industry insiders have raised concerns about the ability of the U.S. Diagnostic Sector to respond to a global pandemic for many years, and within just a few months the COVID-19 pandemic demonstrated that these concerns were valid and that they present risks to patients and to the effort to control rapidly emerging global health risks,” said Barry Weiner, President of Enzo. “In this paper, we outline the challenges in developing and manufacturing new testing technologies and, more importantly, the importance of laboratories to make testing services widely available and to rapidly scale to meet demand at every phase of the pandemic.”
The paper highlights several structural inadequacies that negatively affected the ability of the U.S. healthcare system to respond to the COVID-19 pandemic and identifies a range of best practices for the diagnostics sector that can improve the nation’s healthcare infrastructure and ability to respond to global health crises.
The study also offers perspectives on the emerging issue of testing variants of SARS-CoV-2, which is positioned as a potentially significant challenge that could lead to a new peak in infections. The study outlines the use of technology to probe the nucleocapsid (N) gene targets, presenting the potential to rapidly detect variants including B.1.1.7 (United Kingdom), P.1 (Brazil), and B.1.351 (South Africa) circulating worldwide. The ability to detect the incidence and spread of variants will play a central role in response to COVID-19 infection in the months ahead even as access to vaccines expands.
Elazar Rabbani, Ph.D., CEO of Enzo, commented: “In issues that affect public health, it is essential for leaders in the diagnostics sector to identify and adopt best practices rapidly, but our current siloed approach to diagnostics products and services works against this goal. This new white paper analysis is an attempt to review our industry response to COVID-19 from many directions and identify the workable approaches in product and technology development and delivery and management of testing services that can help us do much better in our response next time.”
Enzo previously published white papers detailing its Comprehensive COVID-19 Program. All 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, 2020. 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.