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CE marking for SERRS-based clinical assay system

31 August 2015 | News

Renishaw Diagnostics has launched the CE-IVD certified RenDx Multiplex Assay System together with its first assay, Fungiplex, a multiplex PCR in vitro test for the qualitative detection of Candida and Aspergillus DNA extracted from blood samples.

The assay is designed for use on the RenDx Multiplex Assay System, an automation and detection platform that allows processing of up to 45 samples in a single run and identifies 12 Candida and Aspergillus species using surface enhanced resonance Raman spectroscopy (SERRS).

Rupert Jones, General Manager of Renishaw Diagnostics, said, “The CE-IVD launch of our RenDx platform and first assay marks a significant milestone, not just in the progress made here at Renishaw Diagnostics but more importantly, for infectious disease diagnostics throughout Europe. The extensive target menu for the Fungiplex assay, together with the high sensitivity that can be achieved through our exceptional detection technology, has the potential to aid earlier diagnosis, reduce overall spend and improve patient outcomes for those susceptible to these life threatening infections. We are looking forward to working with clinicians and laboratories to bring this assay into routine clinical use.”

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