Molecular bloodstream infection testing in Europe

Sepsis is a serious condition with high mortality rates ranging from 10 to 40% (and with septic shock over 50%) that requires rapid medical intervention. In recent years, a number of molecular panels have received CE marking for the diagnosis of bloodstream infections, with some of these including both gram+ and gram- bacteria, as well as yeast and antibiotic resistance markers. The ability to rapidly identify pathogens involved in these infections allows for tailored treatments that increase survival rates and dramatically decrease hospital costs.

However, data from 2017 show that even when clinical laboratories have the appropriate molecular instrumentation that can perform pathogen identification from bloodstream infections, only ~20% are using them for this purpose, largely due to cost factors. The majority of labs still use traditional blood cultures. However, volumes for molecular sepsis testing have grown by ~5% in the last year, so we expect to see continued growth in this sector. Mass spectrometry is also used in sepsis diagnostics at higher volumes than molecular testing, although it does not allow for antibiotic resistance testing and still requires culturing.

While the turnaround time for molecular sepsis testing is lower than traditional microbiology culturing methods (up to 72 hours), it is still ~ 24 hours using most systems due to the need to culture the samples prior to performing molecular analyses. We are beginning to see tests come out that can be performed direct from blood, thus reducing TAT considerably, but this is currently extremely rare in the clinical lab and there are technical issues to overcome.  

Here at dii, as we begin a new round of data collection for our Continuous Molecular Market Assessment in Europe, one of our primary goals this year is to explore the usage and putative growth of multi-marker panels, including those for sepsis testing. We will identify the instrumentation used, kits used (vs LDT) and number of markers in the panel, as well as current test volumes and changes over the last year.

Please contact us for additional information.