SIRS-Lab Receives CE Approval for VYOO® Sepsis Test
The EU regulatory authorities have granted the CE mark for VYOO® from SIRS-Lab, a molecular diagnostic test for pathogen detection in sepsis. With VYOO, clinicians can rapidly and reliably identify causative pathogens (40 bacterial and fungal species detected within 8 hours) as well as important antibiotic resistance markers. Therefore VYOO allows for a customized anti-infective therapy in each patient within the critical hours of treatment. The CE mark will accelerate the implementation of VYOO into clinical routine throughout Europe.
Sepsis, a life-threatening systemic infection, is with more than 2 million cases per year the 2nd cause of death in hospitals after cardio-vascular diseases. SIRS-Lab, a leading molecular diagnostic company in the field of sepsis, has released VYOO in 2007. The VYOO is a multiplex PCR assay which provides significant advantages in clinical practice over currently used methods.
In his comments on the CE approval, SIRS-Lab´s CEO PD Dr Stefan Russwurm states:'In important European clinical centers, for example in Paris or Basel, patients already benefit from the therapeutic advantages provided by VYOO. With the CE status, the full potential of this ground-breaking approach to sepsis diagnostics will be realized.'
For SIRS-Lab, the CE approval is an important milestone enabling the company to manufacture VYOO in accordance to ISO 13485 standards and sell it for routine In-vitro diagnostic use (IVD directive 98/79/EC).
Source: SIRS-Lab GmbH View archived contact details
Posted: December 5, 2008
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