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SIRS-Lab receives CE approval for sepsis test

(PresseBox) (Jena, ) Jena, Dec 3rd, 2008 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 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).

About SIRS-Lab GmbH

Located in Jena, Germany, SIRS-Lab is a molecular diagnostic company which develops and commercializes unique and innovative products to identify and monitor life-threatening infections such as sepsis, one of the major causes of death in hospitals. With its diagnostic suite consisting of VYOO and SIQNATURE, SIRS-Lab's molecular diagnostic portfolio meets the currently unmet medical needs of fast and reliable identification and monitoring of sepsis. Created as a spin-off of the University Clinic of Jena, SIRS-Lab was founded in 2000 by S. Russwurm, K. Reinhart, E. Straube, and H.-P. Saluz, and has currently about 50 employees.

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