IntelligentMDx Receives FDA Clearance for IMDx Flu A/B and RSV for Abbott m2000 assay
CAMBRIDGE, Mass., Sept. 10, 2013 /PRNewswire/ -- IntelligentMDx announced today that the U.S. Food and Drug Administration (FDA) has cleared its automated molecular diagnostic test that detects influenza A, influenza B, and Respiratory Syncytial Virus (RSV) directly from nasopharyngeal swabs from patients with signs and symptoms of respiratory infection. This is the second test from IMDx's portfolio of molecular diagnostic products to be cleared by the FDA for use on Abbott's fully automated m2000 platform and is IMDx's second FDA clearance in five weeks. The IMDx VanR for Abbott m2000 test, which detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci (VRE), received clearance in July 2013.
"It has been a very productive and exciting summer for IMDx," says Dr. Alice Jacobs Nesselrodt, Chairman and CEO of IMDx. "FDA clearance of two products within five 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."
Influenza and RSV infections cause a great health burden on the US population with as many as 60 million individuals becoming infected with influenza each year and approximately 125,000 children under the age of 1 being hospitalized annually with RSV infection. Influenza and RSV manifest similarly; symptomatic patients may experience fever, chills, headache, weakness, sneezing, runny nose, sore throat, and/or a cough. More severe complications including pneumonia and secondary bacterial or viral infections may also occur if infection with influenza and/or RSV is not properly treated. Reactivity studies demonstrated that the IMDx Flu A/B and RSV for Abbott m2000 assay is capable of detecting multiple influenza A/B and RSV strains from various geographical locations, including H1N1, H3N2, and recently emerging H3N2 variant strains. This assay can produce results for up to 94 patient samples simultaneously.
Based in Cambridge, MA, IMDx (www.IntelligentMDx.com) is an innovator of unique proprietary molecular tests equipped with features and benefits to port onto nearly any molecular testing system. IMDx's competitive advantage lies in its extensive bioinformatics capabilities, enabling the production of rapid, low cost high quality products with top performance characteristics to empower clinicians to provide care with greater certainty. Current and future product lines include tests for Infectious Diseases (Healthcare Associated Infections, respiratory diseases, STDs, prenatal testing), oncology and other human genetic targets. The IMDx facilities are ISO 13485:2003 certified and all of the IMDx products are developed and manufactured within a regulatory compliant (FDA QSR, CE-IVDD and cGMP) environment.
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