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IMDx assay receives FDA clearance for influenza, RSV
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The FDA recently approved an automated molecular diagnostic test that detects influenza A, influenza B and respiratory syncytial virus, according to a press release from the manufacturer.
The IMDx Flu A/B and RSV for Abbott m2000 assay (IntelligentMDx) is capable of detecting viruses directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection.
In addition, reactivity studies have shown that the assay is able to identify multiple influenza A/B and RSV strains from various geographical locations, including H1N1, H3N2, as well as emerging H3N2 variant strains. Also, this assay is able to generate results for up to 94 patient samples at once.
This is the second test from IMDx’s portfolio of molecular diagnostic products to receive FDA clearance for use on Abbott’s automated m2000 platform and is IMDx’s second FDA clearance in 5 weeks.
“It has been a very productive and exciting summer for IMDx,” said Alice Jacobs Nesselrodt, MD, chairman and CEO of IMDx. “FDA clearance of two products within 5 weeks of each other is a true testament to our team’s commitment to the rapid production of tests that will have a direct impact on patients worldwide. We are currently pursuing regulatory clearances for other tests from our product portfolio.”