FDA Approves New Flu A/B and RSV Assay

IntelligentMDx announced that the FDA has cleared IMDx Flu A/B and RSV for Abbott m2000 assay, an automated molecular diagnostic test that detects influenza A, influenza B, and respiratory syncytial virus (RSV). 

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This assay can detect the viruses directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.

Reactivity studies showed that the IMDx Flu A/B and RSV for Abbott m2000 assay is able to detect multiple influenza A/B and RSV strains from various geographical locations, including H1N1, H3N2, and emerging H3N2 variant strains. Also, this assay can produce results for up to 94 patients samples at once.

The IMDx Flu A/B and RSV has been cleared for use on Abbott's fully automated m2000 platform.

For more information call (617) 871-6400 or visit IntelligentMDx.com.