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SpeeDx Multiplexed VZV, Herpes, Syphilis Assay Gets CE Mark

NEW YORK (GenomeWeb) – Australian molecular diagnostics firm SpeeDx said today that its PlexPCR VHS multiplex qPCR test has received CE-IVD marking.

The single-well test is designed to detect and differentiate the main causes of genital and oral lesions: herpes simplex virus types 1 and 2 (HSV-1 and -2); Treponema pallidum (syphilis); and varicella-zoster virus (VZV).

All four infections present with clinically similar symptoms, appearing as lesions or ulcers on the skin, mouth, or genital area. Due to the similarities in clinical presentation, molecular-based tests are recommended to detect and differentiate the cause of infection, SpeeDx noted.

"With syphilis rates running at an all-time high, there is a real need to have access to the kind of definitive diagnostics that molecular testing can provide," SpeeDx Chief Technology Officer Elisa Mokany said in a statement. "Testing with PlexPCR VHS supports early detection and treatment decisions, helping to reduce the risk of disease progression and onward transmission."