CE-IVD mark for multiplex PlexPCR VHS test for VZV, herpes and syphilis

SpeeDx has announced that it has received CE-IVD marking for its PlexPCR VHS multiplex qPCR test.

The test offers a single-well solution to cover the detection and differentiation of the main causes of genital and oral lesions: herpes simplex virus types 1 and 2 (HSV-1, HSV-2), Treponema pallidum (syphilis), and varicella zoster virus (VZV).

Validated for use on multiple lesion specimen types, the test is designed to streamline workflows and support rapid, appropriate clinical management of infections with similar symptoms.

“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,” said Elisa Mokany, Chief Technology Officer of SpeeDx. “Testing with PlexPCR VHS supports early detection and treatment decisions, helping to reduce the risk of disease progression and onward transmission.”

The SpeeDx portfolio is based on advanced multiplex technology, and the PlexPCR VHS test is the latest to gain the CE-IVD mark, supplementing the company’s range of market-leading infectious disease and antibiotic resistance detection tests.

“Once again we have collaborated with leading sexual health clinicians and researchers globally in order to quickly develop and market the kind of testing that is needed to rapidly diagnose and properly treat the growing threat of sexually transmitted diseases,” said Colin Denver, CEO for SpeeDx. “This latest product release continues to strengthen our position as the leaders in multiplex molecular diagnostics.”

Diagnostic challenges in treating herpes simplex virus types 1 and 2 (HSV-1/2), T. 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.

Treatments for HSV-1/2 and VZV include acyclovir, famciclovir and valacyclovir, however appropriate dosage requires correct identification of the causative virus, whereas the bacterial infection of T. pallidum can be treated with penicillin-based antibiotics.

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