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

Suggested Articles

LabCorp has licensed a blood test from Genfit designed to identify patients with risky cases of the liver disease NASH.

Philips has launched a compact, single-use device for physically clearing potentially dangerous blood clots lodged in the arms and legs.

CapsoVision has received word from the FDA that they may offer the home use of their ingestible camera pill for scanning the small intestine.