Benzinga | Jul 20, 2021 08:01AM EDT

Enzo Biochem Reports FDA Emergency Use Authorization For Rapid Extraction Method On Proprietary Test System For Detection Of Coronavirus SARS-CoV-2

Enzo Biochem, Inc. (NYSE:ENZ) ("Enzo" or the "Company"), a leading biosciences and diagnostics company, announced today that it has received an expansion of its FDA Emergency Use Authorization (EUA) for the Company's rapid extraction method on its proprietary test system for the detection of coronavirus SARS-CoV-2 including the genetic variants that are now proliferating globally. The EUA enables laboratories to immediately use Enzo's faster extraction process to reduce the time by over one hour, or more than 25%, enabling more test runs on a single instrument. The rapid extraction method can be used on platforms including Enzo's proprietary GENFLEX(r) automated high-throughput platform, Qiagen's QIAsymphony(r) SP lower-throughput platform and Enzo's manual workflow. The AMPIPROBE(r) SARS-Cov-2 Test System includes three components: sample collection, AMPIXTRACT(tm) SARS-CoV-2 Extraction Kit for sample processing, and AMPIPROBE(r) SARS-CoV-2 Assay Kit for detection and analysis.

In its letter of authorization dated July 16, 2021, the FDA stated: "Upon review, we concur that the data and information submitted in EUA200260/S003 and S004/A001 supports the requested updates for use with the AMPIPROBE SARS-CoV-2 Test System."

"One of the most important considerations in this EUA is the fact that Enzo's tests successfully detect genetic variants of SARS-Cov-2 including the Delta and Lambda variants that are rapidly spreading throughout the world. This EUA brings the advantages of this platform to testing sites at a time when demand is expected to grow exponentially," said Elazar Rabbani, Ph.D., Enzo CEO. "Our ability to supply advanced technologies to address needs in molecular testing is another reflection of the strength of our fully integrated business model. We are positioned to support rapid scale up and advance the new solutions in molecular testing that can address major challenges like COVID. We have confidence that as we gain approval for additional molecular diagnostic tests currently under development and evaluation that these efficiency measures can be adopted."

Enzo's fully integrated business model allows the Company to rapidly address capacity and supply limitation issues that have been a significant challenge 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. Enzo offers molecular testing as well as immunological testing for COVID-19 that provides direct measurement of neutralizing antibodies.

Enzo previously published a white paper detailing its COVID-19 Antibody Screening Program.Enzo's white papers are available on Enzo's website at: https://www.enzo.com/coronavirus