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IMDx receives FDA approval for molecular diagnostic test for Abbott m2000 assay

IntelligentMDx (IMDx) has received the US Food and Drug Administration (FDA) approval for its second automated molecular diagnostic test for use on Abbott's fully automated m2000 platform.

The automated molecular diagnostic test detects the presence of influenza A, influenza B, and respiratory syncytial virus (RSV) directly from nasopharyngeal swabs of patients who have the signs and symptoms of respiratory infection.

According to reactivity studies, IMDx Flu A/B and RSV for Abbott m2000 assay is able to detect the presence of influenza A/B and RSV strains from various geographical locations that include H1N1, H3N2, and H3N2 variant strains.

IMDx chairman and CEO Dr Alice Jacobs Nesselrodt noted it has been a very productive and exciting summer for the company.

"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," Dr Nesselrodt added.

In July 2013, IMDx has also received the FDA approval for its IMDx VanR for Abbott m2000 test, which detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci.