- The stock price of Enzo Biochem, Inc. (NYSE: ENZ) increased by over 9% pre-market. This is why it happened.
The stock price of Enzo Biochem, Inc. (NYSE: ENZ) – a leading biosciences and diagnostics company – increased by over 9% pre-market. Investors are responding positively to Enzo Biochem announcing 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 for reducing the time by over one hour, or more than 25%, enabling more test runs on a single instrument. And the rapid extraction method can be used on platforms including 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 3 components: sample collection, AMPIXTRACT SARS-CoV-2 Extraction Kit for sample processing, and AMPIPROBE SARS-CoV-2 Assay Kit for detection and analysis.
In the FDA’s letter of authorization dated July 16, 2021, it was 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.”
Enzo’s 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. And Enzo manufactures its own sample collection, sample processing, and analytics products and supplies at its GMP-certified facilities. Plus Enzo offers molecular testing as well as immunological testing for COVID-19 that provides direct measurement of neutralizing antibodies.
“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. 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.”
— Elazar Rabbani, Ph.D., Enzo CEO
Disclaimer: This content is intended for informational purposes. Before making any investment, you should do your own analysis.