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Enzo Biochem to Present Data on New HCV Assay; Market Product in EU

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Enzo Biochem at the end of the month will present for the first time peer-reviewed data on detection of hepatitis C virus using its new AmpiProbe nucleic acid amplification chemistry, the company said today.

At the European Society of Clinical Microbiology and Infectious Disease annual meeting, scheduled to take place March 31-April 3 in London, Enzo scientists will present a study entitled "Quantitative Detection of HCV RNA in Human Plasma-Serum using the Enzo AmpiProbe HCV RNA Assay."

The abstract has been accepted for publication in Clinical Microbiology and Infection, the official journal of ESCMID, Enzo said.

In addition, the company said that it will seek the CE-IVD Mark for its HCV RNA assay, enabling Enzo to market the product as a diagnostic in the European Union and making it Enzo's first product based on the AmpiProbe technology.

Enzo first disclosed AmpiProbe in a conference call in December discussing the company's fiscal first-quarter financial results (PCR Insider, 12/15/11).

AmpiProbe is a nucleic acid-amplification chemistry and method that Enzo claims is up to 50 times more sensitive than TaqMan-based real-time PCR, and may allow users to perform as many as 20 molecular assays for different targets on a single clinical sample, according to the company.

Enzo President Barry Weiner said in December that the technology requires a smaller initial sample volume, which in turn will "lower the amount of costly reagents needed to run the tests, thereby reducing costs for the clinical laboratory."

AmpiProbe and a new branched DNA signal amplification assay that the company also disclosed in December are the culmination of "a number of years of development work," and became the central focus of Enzo's molecular diagnostic efforts about five years ago, Weiner said at the time.

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