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FDA Clears IMDx Test for Flu, Respiratory Virus

NEW YORK (GenomeWeb News) – Molecular diagnostic firm IntelligentMDx today announced its flu and respiratory virus test has been cleared by the US Food and Drug Administration for marketing in the US.

The FDA cleared IMDx's automated molecular diagnostic test for the detection of influenza A, influenza B, and respiratory syncytial virus directly from nasopharyngeal swabs from patients who exhibit symptoms of respiratory infection. The test is for use on Abbott's automated m2000 platform.

Today's announcement follows FDA's clearance of IMDx's molecular diagnostic test for vancomycin-resistant enterococci in late July, also on the Abbott platform.

According to the Cambridge, Mass.-based firm, reactivity studies indicate that the IMDx Flu A/B and RSV assay can detect multiple influenza A/B and RSV strains from various geographical locations, such as H1N1, H3N2, and recently emergent H3N2 strains. The assay, the company said, can achieve results for up to 94 patient samples simultaneously.