Enzo Announces its GENFLEX Molecular Test Detects Current COVID-19 Variants
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.”