Enzo Biochem Demonstrates Greater Sensitivity Of Its Ampiprobe Platform For Molecular Diagnostics

Clinical Pathology Conference Told of New Data Indicating Outperformance Over Other Commercially Available HCV Viral Load Assays

NEW YORK--(BUSINESS WIRE)--Enzo Biochem, Inc. (NYSE: ENZ) today announced it had demonstrated new thresholds of sensitivity and breadth for its assay for the measurement of Hepatitis C virus (HCV) viral load. The data was generated from clinical samples tested at Enzo Clinical Labs and analyzed by its Translational Diagnostics Group. The assay is based on the proprietary AmpiProbe™ real-time amplification/detection technology platform developed by Enzo Life Sciences, and was reported in a presentation at a conference of the prestigious American Society for Clinical Pathology (ASCP) in Long Beach, CA.

“We are very excited regarding the potential for AmpiProbe™ as a key component in our business strategy to provide high performing molecular diagnostic products and services in a cost-conscious manner to the industry”

The data show that AmpiProbe HCV™ Assay could detect as low as 5.5 IU (International Units) per ml of serum with a positive rate greater than 95%, while the limit of quantification (LOQ) was observed to be 10 IU/ml. The AmpiProbe HCV™ Assay was also able to detect the six main genotypes and subtypes of HCV at concentrations of 15 IU/ml with a hit rate of over 95%. The study was designed to further evaluate the extent of sensitivity of products emanating from the AmpiProbe™ platform.

“The limit of detection (LOD) that we observed was greater than a 50% improvement in analytic sensitivity than leading commercially available HCV viral load assays,” said Dieter Schapfel, MD, Enzo’s Medical Director and lead author of the study. This can be an important development as therapies to treat this wide-spread disease continue to improve.”

A similar presentation was made previously at the meeting of the College of American Pathologists (CAP) earlier this month in Knoxville, TN.

The latest results regarding AmpiProbe’s extended capabilities have been submitted in support of Enzo’s application for regulatory approval.

“The clinical data presented at these highly regarded meetings underscore the continued applications we have been making in this key enabling platform technology,” said Dr. Elazar Rabbani, Chairman and CEO of Enzo. “Over the last year, we have been expanding the reach of the AmpiProbe™ platform to such areas as Hepatitis B virus and HIV viral loads, as well as in our development of a comprehensive panel of assays designed to identify a number of infectious diseases related to women’s health, one of the fastest growing segments of that market.

“Moreover, the results we have shown are even more exciting given the difficulty of using this virus as our first application of AmpiProbe™. Hepatitis C virus is a single stranded RNA virus and, as such, is inherently more unstable and thus more challenging to work with than DNA viruses. Additionally, we needed to demonstrate the applicability of AmpiProbe™ across a wide spectrum of genotypes while simultaneously producing both high levels of sensitivity and linearity of results.”

Dr. Rabbani also pointed out that in the current environment where medical laboratory reimbursements continue to decline while costs of reagents remain the same, or even increase, putting pressure on lab margins, AmpiProbe™ presents an opportunity for commercial and hospital laboratories to improve their profitability. “We are very excited regarding the potential for AmpiProbe™ as a key component in our business strategy to provide high performing molecular diagnostic products and services in a cost-conscious manner to the industry,” he said.

About Enzo Biochem

Enzo Biochem is a pioneer in molecular diagnostics, leading the convergence of clinical laboratories, life sciences and therapeutics through the development of unique diagnostic platform technologies that provide numerous advantages over previous standards. A global company, Enzo Biochem utilizes cross-functional teams to develop and deploy products systems and services that meet the ever-changing and rapidly growing needs of health care both today and into the future. 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.

Except for historical information, the matters discussed in this news release may be considered “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements include declarations regarding the intent, belief or current expectations of the Company and its management, including those related to cash flow, gross margins, revenues, and expenses are dependent on a number of factors outside of the control of the company including, inter alia, the markets for the Company’s products and services, costs of goods and services, other expenses, government regulations, litigations, and general business conditions. See Risk Factors in the Company’s Form 10-K for the fiscal year ended July 31, 2015. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results. The Company disclaims any obligations to update any forward-looking statement as a result of developments occurring after the date of this press release.

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