Roche's new LightCycler SeptiFast Test has received CE Mark ("Conformitée Européenne"), allowing Roche Diagnostics to sell the test for diagnostic use in the European Union. The LightCycler SeptiFast Test can rapidly and reliably detect and identify 25 different sepsis-causing pathogens - including bacteria and fungi - which cause approximately 90 per cent of all sepsis cases. This new test opens up a whole new dimension in sepsis diagnosis as rapid initiation of targeted treatment is crucial in this condition, stated a company release.
Micro-organisms responsible for causing sepsis are traditionally detected in hospital laboratories with the aid of microbiological culture methods which are very time-consuming, generally taking from two to five days to complete, and up to eight days for the diagnosis of fungal infections. By contrast, the LightCycler SeptiFast Test offers the advantage of being able to detect and identify the sepsis pathogens in less than 6 hours - an important time saving for targeted medical treatment. Only after pathogens are correctly identified can targeted therapy using a specific antibiotic begin.
"We are very pleased that we can offer physicians this new test and support their efforts to fight this life-threatening infection. Combining the latest PCR technology and our know-how in molecular diagnostics has allowed us to rapidly develop this potentially life-saving test. I am confident that many patients will greatly benefit from it," states Severin Schwan, CEO, Division Roche Diagnostics and Member of the Corporate Executive Committee of Roche.
Over 18 million cases of severe sepsis occur each year. According to epidemiological studies, severe sepsis accounts for up to 135,000 European and 215,000 American deaths each year. In Germany, severe sepsis accounts for up to 60,000 deaths each year, a figure that makes this condition the third leading cause of death in Germany after coronary heart disease and acute myocardial infarction. Despite improvements in its medical management, sepsis still constitutes one of the greatest challenges in intensive care medicine.