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Dx Focus: Enzo Files HCV Test with NYS; Quidel Gets CE Mark for RSV/hMPV Assay


Enzo Biochem said this week that it has filed an application with New York State for approval of its first assay based on its new AmpiProbe nucleic acid detection technology.

Enzo is seeking approval from the New York State Department of Health for an HCV RNA quantification assay for hepatitis C viral load detection. If approved, the test would be made available through its Enzo Clinical Laboratory branches.

The company also plans to seek the CE IVD mark for the assay in the European Union.

Enzo disclosed AmpiProbe technology in December, claiming that it is up to 50 times more sensitive than TaqMan-based real-time PCR, and will allow as many as 20 molecular assays for different targets to be performed on a single clinical sample (PCR Insider, 12/15/2011).

Quidel said this week that it has received the CE IVD mark for its Molecular RSV + hMPV assay for detecting and distinguishing between respiratory syncytial virus and human metapneuomovirus — two viruses that cause respiratory infections with very similar symptoms.

The Quidel Molecular product line offers PCR reagent kits for use by molecular diagnostic laboratories with existing thermocyclers, such as the ABI 7500 Fast Dx. The assay kits feature simple transport and refrigerated storage (no freezer required); convenient workflow; a short time to result; and other benefits that favorably affect diagnostic test outcome, the company said. Because they share a common extraction protocol, the RSV + hMPV assay can be batched alongside the Quidel Molecular Influenza A+B PCR assay in the same multi-well panel for customized multiplexing capability.

This assay is Quidel's third molecular product offering to receive marketing authorization in the European Union. Quidel Molecular assays for Influenza A+B and hMPV received the CE Mark in August and September of last year, respectively.