Benzinga | Jul 13, 2020 08:30AM EDT

Enzo Biochem Receives Emergency Use Authorization For Proprietary Test System For Detection Of Coronavirus SARS-CoV-2

Authorization Enables Clinical Labs to Purchase and Use Enzo's AMPIPROBE(r) SARS-Cov-2 Test System without Further Validation

Flexible Use on Three Platforms including Enzo's Proprietary Automated GENFLEX(tm) Platform



NEW YORK, NY, July 13, 2020 (GLOBE NEWSWIRE) -- 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(tm) 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 the AMPIPROBE(r) 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(r) 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(r) 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(r) 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(r) 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.