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Dx Focus: IMDx Flu and RSV Tests Get FDA Clearance


IntelligentMDx said this week that the US Food and Drug Administration has cleared the company's automated molecular diagnostic test for influenza A, influenza B, and respiratory syncytial virus for use on the Abbott m2000 platform.

The assay tests for these pathogens directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. Reactivity studies have demonstrated that the IMDx Flu A/B and RSV for Abbott m2000 assay is capable of detecting multiple influenza A/B and RSV strains, including H1N1, H3N2, and recently emerging H3N2 variant strains, from various geographical locations. This assay can produce results for up to 94 patient samples simultaneously.

This is the second IMDx test for the Abbott m2000 to receive FDA clearance in the past two months. In July, the company received FDA clearance for its vancomycin-resistant enterococci, or VME, assay (PCR Insider 8/1/2013).

IMDx and Abbott are developing a broad menu of real-time PCR tests for the m2000 under a multiyear distribution agreement between the companies signed in 2011 (PCR Insider 3/17/2011).