IntelligentMDx wins CE mark for new herpes test

Massachusetts' IntelligentMDx is once again turning to Europe to debut a new diagnostics test.

The Cambridge, MA company disclosed recently that it has obtained a CE mark for a new test that detects the herpes simplex virus in male or female genital/oral lesions and spinal fluid, and also determines whether it is HSV 1 or 2, the Boston Business Journal reports.

IntelligentMDx is also relying on a large partner for the test's market launch. The IMDx HSV-1/2 is the company's fourth automated high-throughput molecular diagnostic test designed to be used with Abbott's m2000 system. The automated process enables testing of up to 94 patient samples at the same time, in under 6 hours, according to the company. Other tests focus on Group B Streptococcus, vancomycin-resistant Enterococci and toxigenic C. difficile. All are approved for use in Europe, but not the U.S. or Canada.

The market potential for a more precise herpes diagnostic is significant. As Intelligent MDx notes, 4 billion people globally are infected with the virus, and the incidence of HSV-1 infection is second only to the common cold.

While some are focusing on developing better diagnostics to help manage herpes, many other companies and researchers are pursuing improved anti-herpes drugs or outright vaccines.

- read the BBJ story
- check out the CE mark announcement