Quidel ($QDEL) has its latest molecular diagnostic test approval in hand, this time a CE mark for a blood test that screens for herpes plus a virus that causes chicken pox and shingles.
The San Diego, CA-based company's European regulator nod affects its Quidel Molecular Direct test, which detects herpes simplex viruses 1 and 2 (HSV 1 +2) and the varicella-zoster virus, which can cause chicken pox and the painful condition that sometimes follows--shingles. It will be marketed as a complementary product going with the company's ELVIS cell-based diagnostic for herpes detection.
Quidel CSO Timothy Stenzel said in a statement that the new test will help boost the standard of care, because it can screen for both viruses and their iterations in a precise, definitive way. That's an improvement over the status quo, where patients with atypical lesions often face a diagnosis for the incorrect condition or even another infection entirely. It is also made for rapid diagnosis in about one hour, through samples obtained from lesions.
Whatever the improvement, herpes, simply put, is big business. The company estimates that there are 800,000 new herpes cases annually in the United States alone, and that one in 6 Americans between the ages of 14 and 49 have a genital HSV 2 infection.
Quidel's Massachusetts-based rival IntelligentMDx sees an even bigger market potential for a more precise herpes diagnostic test, estimating 4 billion people globally are infected with some form of the virus. The company's new IMDx HSV-1/2 test works in 6 hours, and the high-throughput molecular diagnostic relies on samples from male or female genital and oral lesions, and also spinal fluid.
Quidel, meanwhile, has successfully obtained approvals in recent years for molecular diagnostic tests focused on the C. difficile virus, which is associated with influenza, among other targets.
- read the release
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