Horizon2020 project SMARTDIAGNOS: Cube Dx delivers early diagnostics of sepsis pathogens

The current pandemic of the new Corona virus (SARS-Cov-2) highlights the dangers of infections and demonstrates the need for fast and reliable diagnostic tools. However, even before the Corona pandemic a more deadly threat was and is largely neglected: sepsis.

Sepsis causes more than 8 million deaths annually and is caused mainly by bacteria. The ongoing spread of antibiotic resistance puts even more pressure on the health systems. Crucial for survival and quick recovery is an early diagnosis of the causative pathogen and its possible drug resistances.

The new generation of the instrument hyborg Dx RED2 and the newly developed tests to identify sepsis pathogens early are CE-IVD marked.

The EU funded SMARTDIAGNOS consortium coordinated by the Danish Technical University (DTU) and constituting of 10 partners from five different EU countries has developed new diagnostic technologies to detect sepsis causing pathogens in blood without the need for microbiological culturing. The test reduces time to result from average 48 hours down to 3 hours and has the potential to reduce mortality and cost. 

The progression of sepsis - or blood poisoning - is very quick. A person's condition can become life threatening in just a few hours. The incidence of sepsis is on the rise and is driven by an aging population, advances in medicine and the antibiotic crisis.

Clinicians still struggle with diagnosing sepsis early. Only an early diagnosis allows for early targeted treatment and hence reducing high mortality, a number of complications and significant costs. Today, blood culture is the method used to diagnose the causative pathogen, and it normally takes around 48 hours to get the results.

To overcome this limitation researchers in molecular biology and nanotechnology have teamed up with diagnostic SMEs, clinical microbiologists and business accelerators to form the EU HORIZON2020 SMARTDIAGNOS project consortium (www.smartdiagnos.eu). Aim of the project was to develop new systems to diagnose a wide range of pathogens (bacteria and fungi) and resistance mechanisms in whole blood in just 3 hours.

The 4 years project was recently concluded with a clinical performance evaluation in three hospitals (partners of SMARTDIAGNOS consortium) across Europe.