SIRS-Lab has completed enrolling patients in a clinical study of its VYOO molecular diagnostic test, designed to detect presence of pathogens' genetic material from whole blood.
The prospective, blinded multicenter study, which has enrolled patients from 13 key medical centers across Germany, is designed to demonstrate the safety and efficacy of VYOO test in identifying ICU patients with suspected sepsis.
In addition, the company has continuously invested in further automation of VYOO, reducing hands-on time for laboratory technicians to 70 minutes per run with an overall test time of 7 hours.
By using the VYOO test, the user can get results through software, fully integrated on the microarray reader within a much shorter time.
Hannover University Hospital professor and trial principal investigator Tobias Welte said 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," Welte added.
The company said VYOO test results are expected in early 2013 and further development of a new version of VYOO has been completed.
SIRS-Lab CEO Barbara Staehelin said with the full enrollment of the trial, the company has reached one of the important milestones in compiling the data for the market launch of VYOO test.
"The centers have proven exceptional motivation throughout the trial and we are grateful to be so generously supported by the sepsis community," Staehelin added.