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SIRS-Lab Completes Enrollment in Clinical Trial to Evaluate Pathogen Detection Test VYOO® for Patients with Suspected Sepsis

SIRS-Lab, the innovative molecular diagnostics company specialized in sepsis, today announced the successful completion of recruitment in its 1’000-patient trial. The prospective, blinded multicenter study involved 13 key medical centers across Germany and focused on ICU patients. Results are expected in early 2013. The evaluated VYOO(R) test detects the presence of genetic material from a broad panel of pathogens in whole blood, faster than current methods. The test covers bacteria, fungi and genes associated with antibiotic resistances. In parallel, further development for a new version of VYOO(R) was completed.

Principal Investigator of the trial, Professor Tobias Welte of the University Hospital in Hannover: “Detection of the sepsis-causing pathogen is an important prerequisite for choosing the adequate antibiotic or antifungal therapy, a key step for the survival of the patient. The trial is the first of its kind and of remarkable magnitude for molecular diagnostic testing for sepsis. It will deliver data about test utility compared to conventional methods to identify microbes in ICU patients with suspected sepsis.”

Barbara Staehelin, CEO of SIRS-Lab, about the study: “With the full enrollment of the trial, we reached one of the most important milestones in compiling the data for the market launch of our test. The centers have proven exceptional motivation throughout the trial and we are grateful to be so generously supported by the sepsis community. Together, we strive to lower the burden of this cruel disease.”

At present, traditional diagnostic methods often cannot identify the microbe responsible for the infection and can take several days to complete. Molecular diagnostics like VYOO(R) offer the possibility to test for a panel of microbes within a much shorter time. The results offer same-day, reliable and valuable additional information for clinicians, allowing rapid tailoring of the patient’s therapy.

During the study, SIRS-Lab has continuously invested in further automation of VYOO(R), reducing hands-on time for laboratory technicians to 70 minutes per run with an overall test time of 7 hours. The user gets the results data through software, fully integrated on the microarray reader. On-board positive and negative controls ensure test performance. SIRS-Lab obtained European marketing clearance (CE mark) for the current VYOO version in May 2012.

Sepsis occurs when microbes enter the bloodstream and trigger a severe inflammatory response by the patient’s body. This is often life threatening, and the search for the appropriate antibiotic or antifungal treatment can be a race against time. This is a challenging area for new diagnostics because the amounts of bacteria or fungi that cause the disease are extremely small. Sepsis affects more than 2 million people per year and is the second leading cause of death in hospitals.

Headquartered in Jena, Germany, with offices in Basel, Switzerland, SIRS-Lab is a molecular diagnostic company that develops and commercializes unique and innovative products to identify and monitor life-threatening infections, as well as technologies to enhance the performance of microbial molecular tests in a variety of fields. The company has developed a proprietary sample preparation technology LOOXSTER(R), that can increase the sensitivity of molecular assays for pathogens: This is used within VYOO(R), SIRS-Lab’s CE-marked molecular diagnostic test for blood-stream infections in hospitals.

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