NEW YORK (GenomeWeb News) – Enzo Biochem said today that it has filed an application with New York for approval of its first assay run on its AmpiProbe nucleic acid detection platform.
Enzo is seeking approval from the New York State Department of Health for the HCV RNA Quantification assay for viral load detection. If approved, the firm would make it available through its Enzo Clinical Laboratory. The company also plans to seek CE-IVD designation for the assay for marketing in the European Union.
In a statement, the New York-based company said that it believes the AmpiProbe platform provides greater sensitivity than traditional PCR-based tests and would require less sample input, "facilitating paneling or multiple preparations of tests per sample leading to economic efficiencies."
As GenomeWeb Daily News' sister publication PCR Insider reported recently, Enzo claims that the AmpiProbe technology is up to 50 times more sensitive than TaqMan-based real-time PCR, and as many as 20 molecular assays for different targets may be performed on a single clinical sample.
"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," Enzo CEO Barry Weiner said.
Enzo reported on Monday that revenues for its fiscal second quarter rose 5 percent year over year.