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 State’s Department of Health ensures the quality of clinical laboratory tests, among others, through what is recognized as the country’s 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 assay’s 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 Enzo’s 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).