Last updated on April 23, 2014 at 21:24 EDT

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

August 13, 2012

JENA, Germany, August 14, 2012 /PRNewswire/ –

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

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.

About sepsis and life threatening infections

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.

About SIRS-Lab

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.

        Contact SIRS-Lab GmbH
        Axel Kunz, Corporate Communication
        Phone: +49-3641-3103-333
        pr@sirslab.com, http://www.sirslab.com

        Press Room: http://www.sirslab.com/news/press-room
        Follow: http://twitter.com/SIRSLab


Source: PR Newswire