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EU Clears Prodesse’s H1N1 Test

NEW YORK (GenomeWeb News) – Prodesse’s molecular diagnostic test for H1N1 swine flu infections has been cleared by EU regulators for commercialization in Europe.

The firm, which recently became a subsidiary of Gen-Probe, received the CE Mark clearance for its ProFlu-ST assay as a diagnostic to differentiate among influenza strains.

The RT-PCR-based test detects and identifies the 2009 H1N1 virus, the seasonal influenza A/H1 virus, and the seasonal A/H3 virus.

Because these three influenza A subtypes have different susceptibilities to antiviral drugs, identifying the strain can help doctors treat patients appropriately.

Prodesse said it expects that the ProFlu-ST assay will be used in conjunction with its ProFlu+ assay, which detects influenza A and B and respiratory syncytial virus, and received CE mark in 2007.

The US Food and Drug Administration last month granted an emergency use authorization for Prodesse’s ProFlu-ST assay in the CLIA labs in the US, but it has not granted approval to 2009 H1N1 tests for the virus.