Molecular diagnostics company, SIRS-Lab, has finished enrolling patients in a clinical study of its VYOO molecular diagnostic test, designed to detect the presence of pathogens' genetic material from whole blood.
The prospective, multicentre study has enrolled patients from 13 key medical centres across Germany to demonstrate the safety and efficacy of VYOO in identifying ICU patients with suspected sepsis.
The company has also 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 VYOO, the user receives results through software, fully integrated with the microarray reader, within a much shorter time.
Hannover University Hospital professor and trial principal investigator Tobias Welte said detection of the pathogen causing sepsis is important for choosing the appropriate antibiotic or antifungal therapy; a key step for the patient's survival.
"The trial is the first of its kind and of remarkable magnitude for molecular diagnostic testing for sepsis," Welte said.
"It will deliver data about test utility compared to conventional methods to identify microbes in ICU patients with suspected sepsis."
The VYOO test results are expected in early 2013 and a new version of VYOO has been developed, according to the company.
SIRS-Lab CEO Barbara Staehelin said that with the full enrolment of the trial, the company had reached an important milestone in compiling data for VYOO's market launch.
"The centres have proven exceptional motivation throughout the trial and we are grateful to be so generously supported by the sepsis community," Staehelin said.