IntelligentMDx wins CE mark for disease diagnostic test

19 July 2012 (Last Updated July 19th, 2012 18:30)

IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system to detect genital and oral lesions.

Herpes simplex virus

IntelligentMDx has received CE mark approval for its automated molecular HSV-1/2 test, designed for the Abbott m2000 system to detect genital and oral lesions.

The HSV-1/2 for Abbott m2000 assay, which tests up to 94 patient swab samples simultaneously in fewer than six hours, is designed to detect the herpes simplex virus (HSV) viral DNA and differentiate HSV-1 and HSV-2 in male and female genital or oral lesions and cerebral spinal fluid.

As results are obtained using a direct swab taken from a symptomatic male or female patient, minimal hands-on time is required, according to IntelligentMDx.

The automated molecular test demonstrated 100% sensitivity and 97.2% specificity for HSV-1, while 100% sensitivity and 98.8% specificity was demonstrated for HSV-2, as compared to clinical samples classified for HSV-1 and HSV-2 using culture and a molecular reference method.

"As results are obtained using a direct swab from a symptomatic male or female patient, minimal hands-on time is required."

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.

Alice Jacobs, IntelligentMDx chairman and CEO, said automated molecular diagnostics are becoming the method of choice for fast and reliable diagnosis of infections.

"We are proud to play a role in easing the global burden of herpes virus infections through rapid and precise diagnostics," Jacobs added.

"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.


Image: Transmission electron micrograph of herpes simplex virus. Photo:CDC/Dr. Erskine Palmer.