About Smartdiagnos

Sepsis is a medical emergency

Sepsis arises when the body’s response to an infection damages its own tissues and organs. It can lead to shock, multiple organ failures and death, especially if it is not recognized early and treated promptly. For patients with an infection, sepsis is the most common pathway to death. Worldwide around 9 million people die from sepsis every year.

Illustration 1
Number of deaths annually in the US/Rapid sepsis diagnosis is essential for survival rate
Source: http://www.dsxtherapeutics.com or  www.sepsis.com

SmartDiagnos goes beyond state-of-the-art on these 5 diagnostic performance indicators:

Tabel

The SmartDiagnos solution will improve clinical decisions and drastically reduce mortality and long-term side effects by providing information for targeted antimicrobial therapy within 1-3 hrs. Fast and appropriate treatment will decrease morbidity and mortality of sepsis by up to 20% 

The technology

The proposed equipment is based on DNA-based KET (micro-nano-bio) for high-sensitive specific diagnostics. It will allow fast and precise sepsis diagnoses to initiate effective antimicrobial therapy. It will be developed in 2 versions for 2 types of applications:

  1. The POC system enables an evidence-based initial diagnosis to start sepsis treatment
  2. The LAB system enables an in-depth analysis providing the “bigger picture” and confirming or adjusting the initial diagnosis.

After the end of the project, a clinical performance test must be carried out prior to marketing. 

Illustration 3

Why are current solutions not good enough?

Existing commercially available solutions all suffer from either low diagnostic sensitivity, limited panel of pathogens, no or very limited test for antimicrobial resistance and complex handling and lengthy procedures. 

Graphic illustration of current procedure for sepsis diagnostic and treatment (click for larger illustration)

Source: Bloos, F., Sachse, S., Kortgen, A., Pletz, M. W., Lehmann, M., Straube, E., … Bauer, M. (2012). Evaluation of a polymerase chain reaction assay for pathogen detection in septic patients under routine condition: an observational study. PloS One, 7(9), e46003. doi:10.1371/journal.pone.0046003

Globally some 27 million people experience sepsis each year; only around 18 million of them survive - between 28% and 70% of people who get sepsis die (depending on quality of the health care system and patient specific conditions).

In Europe, more than 1½ million experience sepsis.

Sepsis is one of the main causes of death in intensive care units worldwide, and within the EU more than 35% of patients in intensive care units suffer from sepsis, of which 27% die5F

In Europe, the costs of severe sepsis are typically 23,000-42,000 EUR per sepsis period per patient6F

In the EU 300,000-500,000 severe sepsis cases (60-100 per 100,000 inhabitants) costs 7-21 billion EUR in the health sector per year - this cost can be significantly reduced if better and faster diagnostics become available
Updated by Tine Elkjær Jørgensen on 15 December 2016

What is the problem?

  • >9 million people die every year from Sepsis

    >In septic shock, each hour of delayed diagnosis and therapy increases the risk of death by approximately 8%


  • >Sepsis is extremely difficult to differentiate from non-infectious systemic inflammatory response syndrome (ni-SIRS) that shows similar symptoms, but requires a different treatment


  • >Often sepsis survivors have to live with long cognitive and physical impairments

What is the solution?

>Fast identification of pathogens causing sepsis and antimicrobial resistance

 >Early and accurate sepsis diagnosis for an effective antimicrobial therapy

 

>Diagnostic sensitivity – we must catch (almost) all sepsis incidents

 

>Diagnostic specificity – accurate diagnosis

 

>Patient stratification – differentiate sepsis from other inflammatory conditions

The science

>SmartDiagnos will combine a number of innovative technologies 

 

>3D sample concentration to process large amount of raw sample

 

>Direct PCR in the 3D microstructure to circumvent DNA extraction step

 

>Solid-phase PCR to achieve unlimited multiplexing capability

 

>Supercritical angle fluorescence (SAF) microlens array for enhanced fluorescence detection and precise quantification of sepsis-related pathogens.

Updated by Tine Elkjær Jørgensen on 15 December 2016