Enzo Biochem’s Clinical Laboratory Applies for NY State Health Department Approval for First Assay Based on Its AmpiProbe™ Amplification Platform
Highly Efficient Economic Test Also Provides Greater Sensitivity Than Conventional PCR-based Assays
Other AmpiProbe" Platform-Based Assays In Development for Nucleic Acid Testing Market
NEW YORK--(BUSINESS WIRE)-- Enzo Biochem Inc. (NYSE:ENZ) announced today the filing of an application with the New York State Department of Health for the first assay based on its proprietary AmpiProbe" nucleic acid detection platform. Upon approval, the Company plans to market its HCV RNA Quantification Assay for viral load determination through its Enzo Clinical Laboratory. The Company previously announced plans to seek CE-IVD designation for this assay in order to make it available as a diagnostic product in the European Union.
New York States Department of Health ensures the quality of clinical laboratory tests, among others, through what is recognized as the countrys most comprehensive licensure program.
The Company said that, compared with other leading platforms currently in use in what it estimates is a $2 billion market for nucleic acid-based tests, assays based on AmpiProbe" platform may provide substantially greater sensitivity than conventional PCR-based tests. As a result, AmpiProbe" assays would require less sample input, facilitating paneling or multiple preparations of tests per sample leading to economic efficiencies. The assays utilization of this particular Enzo proprietary technology may thus reduce the need of obtaining multiple samples from patients, an important factor for both physicians and the patients.
Our studies indicate that AmpiProbe" based assays can provide a superior testing methodology through greater operational efficiency and economy than any similar platform currently on the market, said Barry Weiner, Enzo President. By providing cost savings to clinical laboratories as well as potential benefits to medical practices, we believe that our AmpiProbe" platform can lead to a new generation of nucleic-acid based assays.
AmpiProbe" HCV is the first assay developed from Enzos proprietary nucleic acid amplification technology, and we view it as potentially a promising example of other molecular-based products that we currently have under development, Mr. Weiner added.
The Company previously announced that it would present for the first time clinical findings related to AmpiProbe" at the March 31, 2012 meeting in London, England, of the European Society of Clinical Microbiology and Infectious Diseases. An abstract, entitled Quantitative Detection of HCV RNA in Human Plasma-serum using the Enzo AmpiProbe" HCV RNA Assay, has been accepted for publication in the European Society of Clinical Microbiology and Infectious Diseases (ESCMID) official journal, Clinical Microbiology and Infection (CMI).
About Enzo Biochem (ENZ)
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 rapidly 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 Biochems 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 Companys products and services, costs of goods and services, other expenses, government regulations, litigations, and general business conditions. See Risk Factors in the Companys Form 10-K for the fiscal year ended July 31, 2011. 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.
Enzo Biochem, Inc.
Steven Anreder, 212-532-3232
Michael Wachs, 212-732-4300
Source: Enzo Biochem, Inc.Copyright Business Wire 2012