TGA approval for SpeeDx PlexPCR® VHS | HSV-1&2, VZV & TP |
SpeeDx Multiplexed VZV, Herpes, Syphilis Assay is now fully registered as an IVD in the Australian market.
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.
“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.”