Study Evaluates Diagnostic Test for Blood Stream Infection

The first patient has been enrolled in a 1,000-patient clinical study evaluating a diagnostic test for blood stream infection.

The multicenter trial initiated in February 2011 being performed in 11 key centers across Germany, will deliver data about the utility of the polymerase chain reaction (PCR) test compared to conventional methods to identify microbes in ICU patients with suspected sepsis. Results are expected in early 2012.

Traditional diagnostic methods can take several days to complete, and often miss the infection. With molecular diagnostics like the VYOO test, the microbe can be identified within hours, allowing rapid tailoring of the patient's therapy.

The study led by the president of the German Sepsis Society Prof. Dr. Tobias Welte (Hannover, Germany), will deliver data about the sensitivity and specificity of VYOO compared with the current standard blood culture and the clinical diagnosis at the hospital. It will evaluate how VYOO supports the clinician's decision-making and delivers critical information to support early and targeted anti-infective therapy.

Barbara Staehelin, CEO of SIRS-Lab (Jena, Germany), and the producers of VYOO, said about the study, "In this study, clinicians and microbiologists in Germany's top centers combine efforts to improve critical care in sepsis. We are excited to now enter the clinical development stage with VYOO and are looking forward to see the test perform in a routine laboratory environment."

SIRS-Lab has developed a proprietary sample preparation technology LOOXSTER that can increase the sensitivity of molecular assays for pathogens. This is used within VYOO, SIRS-Lab's CE-marked molecular diagnostic test for blood-stream infections in hospitals.

Related Links:
German Sepsis Society
SIRS-Lab