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SpeeDx Receives CE-IVD Mark for Assay to Distinguish HSV-1&2 and VZV

NEW YORK (GenomeWeb) – Australian molecular diagnostics manufacturer SpeeDx announced today that it has received the CE-IVD mark for a multiplex qPCR assay to detect and discriminate herpes simplex virus (HSV) 1 and 2 as well as varicella zoster virus (VZV).

The PlexPCR HSV-1&2, VZV multiplex qPCR kit is the first SpeeDx test to receive CE-IVD status. It is a single-well solution validated for use on multiple-lesion specimen types, SpeeDx said in a statement.

While HSV is spread through oral or sexual contact, VZV causes chickenpox in children and young adults as well as herpes zoster, also called shingles, in adults and aged populations.

All three viruses present with lesions or ulcers on the skin, mouth, or genital area. About 3 percent of genital lesions thought to be caused by HSV-1 or HSV-2 may actually be VZV, according to one study, and molecular tests have become the gold standard to detect and differentiate the cause of infection, SpeeDx said. Treatments of the viruses include acyclovir, famciclovir, and valacyclovir, but dosage depends on the causative virus.

Competition for the test may come from Quidel, which has a Lyra Direct HSV 1+2/VZV multiplex real-time assay that received CE mark in 2013. It also received de novo clearance in the US in 2014 and has described efforts to port that assay onto its isothermal Solana system. Researchers in the US have also shown a similar assay could be performed on the Becton-Dickinson BD Max system.

SpeeDx recently opened offices in London, from which it plans to launch CE-marked tests. It is also moving toward CE marking of a test for antibiotic-resistant Mycoplasma genitalium, as previously reported.