SpeeDx Receives CE-IVD Mark for PlexPCR HSV-1&2, VZV Kit

SYDNEY, AUSTRALIA--(Marketwired - June 29, 2016) -

SpeeDx Pty., Ltd. announced today it has received CE-IVD marking for its PlexPCR™ HSV-1&2, VZV multiplex qPCR kit. The new multiplex molecular diagnostic test offers a single-well solution to cover the detection and differentiation of three herpes viruses (HSV-1, HSV-2, VZV) in addition to an internal control. Validated for use on multiple lesion specimen types, the test is designed to streamline herpes testing workflows and support appropriate clinical and therapeutic management for infections that present similarly.

Tim Read, MD, a sexual health physician at Melbourne Sexual Health Centre, said: “Our previous study highlights that a small but significant number of cases of presumed genital HSV infection are caused by VZV, and that zoster needs to be considered as a differential diagnosis for genital herpetic lesions.”

The study, published in Sexually Transmitted Infections, found that 3 percent of genital infections were positive for VZV. Infections identified to be VZV follow separate treatment and clinical counselling paths to HSV further highlighting the need for VZV testing on genital lesions(1).

“We are delighted to receive CE-IVD marking for this new high-performance benchmark for multiplex qPCR HSV and VZV testing,” said Colin Denver, Vice President of Sales & Marketing for SpeeDx. “This marks an exciting time for SpeeDx in Europe following our partnership with Goffin Molecular Technologies B.V. and the establishment of our European headquarters.”

The PlexPCR™ HSV-1&2, VZV kit is the first SpeeDx test to receive CE-IVD status. SpeeDx has a range of infectious disease and antibiotic-resistance detection kits in its portfolio based on its unique and market-leading multiplex technology.

About herpes simplex virus types 1 and 2 (HSV-1&2) and varicella zoster virus (VZV)
HSV is a contagious infection spread through oral or sexual contact causing a life-long infection, although treatment can reduce symptoms. VZV is a commonly occurring virus causing chickenpox in children, teens and young adults as well as herpes zoster (shingles) typically in adults and aged populations. All three viruses present with clinically similar symptoms appearing as lesions or ulcers on the skin, mouth (“cold sores”), or genital area. Due to the similarities in clinical presentation, molecular-based tests have become the gold standard to detect and differentiate the cause of infection. Treatments of HSV-1&2 and VZV include acyclovir, famciclovir, and valacyclovir; however appropriate dosage requires correct identification of the causative virus.

About PlexPCR™ and ResistancePlus™
PlexPCR™ and ResistancePlus™ constitute multiplex qPCR kits for detection of infectious disease pathogens and antimicrobial resistance markers, respectively. Powered by the company’s proprietary PlexZyme™ and PlexPrime™ technologies, both product lines offer high multiplexing capability for better, more streamlined infectious disease management. With increased ability to detect more pathogens, as well as multiple genetic markers, every PlexPCR™ and ResistancePlus™ test provides more actionable information for laboratories and clinicians alike.

About SpeeDx
Based in Sydney, Australia and founded in 2009, SpeeDx is a privately owned company specializing in innovative multiplex real-time polymerase chain reaction (qPCR) solutions for clinical diagnostics. SpeeDx has a portfolio of market leading detection and priming technologies to enable new healthcare paradigms based on improved delivery and reduced costs. SpeeDx has a proven track record of scientific discovery and strives to provide cutting edge clinically relevant tools for the clinical diagnostic market. For more information on SpeeDx please see: http://www.speedx.com.au/

(1) C J Birch, J D Druce, M C Catton, L MacGregor, T Read. Detection of varicella zoster virus in genital specimens using a multiplex polymerase chain reaction. Sex Transm Infect. 2003;79:298-300