Policy & Regulation
Enzo Biochem Claims Milestone with Approval of Proprietary GenFlex Platform
13 February 2020 - - US-based molecular diagnostics Enzo Biochem, Inc.'s (NYSE: ENZ) Enzo Clinical Labs, Inc. unit has received New York State approval for its CT/NG/TV tests using liquid-based cytology sample collection on its proprietary GenFlex platform, the company said.

GenFlex is a commercially available sample-to-result molecular diagnostic platform that includes sample collection, sample processing, amplification and detection.

The GenFlex open system delivers high-throughput, high capacity, workflow efficiency and flexibility at a much greater level of affordability than existing systems.

This is the latest successful development in Enzo's strategic plan to provide a cost-effective, comprehensive menu of molecular diagnostic products and services.

This significant milestone achievement highlights Enzo's continued ability to deliver high performance, open, flexible, adaptable and cost-effective products, devices and services.

Compared favorably to all other proprietary platforms dominating the diagnostic testing market, Enzo's GenFlex platform offers 30-50% cost-savings over current closed systems.

GenFlex addresses the USD 450m annualized global CT/NG/TV diagnostic market as well as the USD1.3 bn Women's health market. Extensions of the Genflex platform, which Enzo is currently developing, could eventually address the entire USD 7bn molecular diagnostic market.

According to the Centers for Disease Control and Prevention, there are more than 1.7 m cases of Chlamydia, 500,000 cases of Neisseria Gonorrhea and 3.7 m cases of Trichomonas Vaginalis in the United States per annum.

The approval of the GenFlex platform is directly related to the successful development work completed on Enzo's proprietary Ampiprobe detection technology which was initially validated on third-party research-only instrumentation.

GenFlex overcomes challenges inherent in existing platforms which may include: the extraction system necessitating expensive sample processing reagents, multi-year provider contracts, low-capacity throughput, and multiple independent instruments for extraction, PCR set-up, and detection.

Adopting Ampiprobe detection technology into third-party platforms was a necessary first step towards Enzo's development of a fully automated system. However, with Enzo's GenFlex approval, Enzo's goal of commercialising a fully automated high-throughput platform with 30-50% cost savings is being realised.

Enzo Biochem is 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.

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.

Enzo Biochem, Inc. has filed and mailed to shareholders a definitive proxy statement and proxy supplement on Schedule 14A and accompanying WHITE proxy card with the Securities and Exchange Commission in connection with the solicitation of proxies from the company's shareholders with respect to its 2019 annual meeting of Shareholders.

The company has filed in preliminary form and intends to file and mail to shareholders a new definitive proxy supplement and new GOLD proxy card. Shareholders are strongly encouraged to read the company's proxy statement, proxy supplements, accompanying GOLD proxy card and all other documents filed with the SEC as they become available carefully and in their entirety as they contain important information.