JENA, Germany--(BUSINESS WIRE)--SIRS-Lab today announced that the EU regulatory authorities have granted the CE mark for VYOO, a molecular diagnostic test for pathogen detection in sepsis. With VYOO, clinicians can rapidly and reliably identify causative pathogens 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 cutting-edge pathogen detection test provides significant advantages over currently used methods in clinical practice.
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).
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Axel Kunz, +49 3641 508 430
Source: SIRS-Lab GmbH