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IntelligentMDx HSV molecular diagnostic assay wins CE mark

IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system.

The HSV-1/2 for Abbott m2000 assay detects Herpes Simplex Virus (HSV) viral DNA and differentiates HSV-1 and HSV-2 in male and female genital or oral lesions and cerebral spinal fluid.

IntelligentMDx said the HSV-1/2 for Abbott m2000 assay tests up to 94 patient swab samples simultaneously in less than six hours.

The automated molecular test demonstrated 100.0% sensitivity and 97.2% specificity for HSV-1, while 100.0% sensitivity and 98.8% specificity for HSV-2, as compared to clinical samples classified for HSV-1 and HSV-2 using culture and a molecular reference method.

In addition to differentiation of HSV-1 and HSV-2 viruses, the company’s test menu for use on the Abbott m2000 system can detect Group B Streptococcus, vancomycin resistant Enterococci (vanA/ vanB) and toxigenic C. difficile.

IntelligentMDx chairman and CEO Alice Jacobs said, "The robust performance and automated nature of the IMDx HSV-1/2 for Abbott m2000 assay can aid in the diagnosis of patients and support faster treatment decisions."

IntelligentMDx said the HSV-1/2 for Abbott m2000 assay is not available for sale in the US or Canada.