Enzo Biochem Inc. announced that the Company has made its first peer-reviewed presentation of its novel AmpiProbe™ platform, encompassing low cost, and high sensitivity, real time nucleic acid amplification and detection assays, at the annual meeting in London of the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).
The Company’s presentation, titled “Quantitative Detection of HCV RNA in Human Plasma-Serum using the Enzo AmpiProbe™ HCV RNA Assay,” detailed the specifications and performance characteristics of the first diagnostic product developed utilizing the AmpiProbe™ platform.
“The assay is the first product based on our next-generation molecular diagnostics platform,” said Elazar Rabbani, CEO of Enzo Biochem. “Our plan is to systematically introduce a number of additional products that could deliver a panel of relevant diagnostics that can be performed simultaneously from a single clinical sample, a program now underway. The objective is to develop assays that are expected to provide a cost-effective solution to clinical labs while providing physicians with more comprehensive medical information on a highly economic and time consuming basis.”
Enzo‘s AmpiProbe™ Hepatitis C virus RNA assay was tested over hundreds of clinical samples and found to be reproducible, accurate and precise, the presentation indicated. The assay was found to be highly specific to HCV, showing no cross reactivity to other infectious viruses and no susceptibility to potentially interfering substances associated with clinical samples. In addition, the AmpiProbe™ HCV RNA assay was found, as compared to similar diagnostics products, to achieve a greater enhanced sensitivity that allows for a more convenient and efficient workflow requiring significantly less starting material. The data also suggests that it may facilitate paneling of multiple independent assays from the standard amount of starting material.
The Company recently announced that it had completed a submission to the New York State Department of Health seeking approval to utilize this assay as a laboratory developed test and that it also has commenced the process for obtaining CE-IVD (Conformité Européenne in vitro diagnostic) designation, which would allow it to market its HCV RNA assay as a diagnostic product in the European Union.