Infections are the third biggest killer in the developed world and the top killer in emerging and resource poor countries. In the western world, the associated economic burden is estimated to exceed € 30 billion each year.

Beating bacterial infections has the potential to save millions of lives – and millions of € – each year. The most important step is ensuring accurate treatment as early as possible. However the lack of diagnostic tools leads to treatment decisions based on observations and experience - empiric antibiosis. According to a study inadequate treatment schemes are applied in about 40% of VAP cases. Often, this can make therapy more complicated, expensive and results in worsened prognoses. Clinical studies show that each hour of delay in administering an effective antimicrobial therapy results in a decrease in survival. Inappropriate initial treatment also contributes to drug resistant variations – such as when broad-spectrum rather than targeted antibiotics are used.

Antibiotic-resistant pathogens in healthcare settings are a growing threat. More than 70% of the bacteria that cause HAIs show resistance to at least one of the drugs most commonly used to treat them. Hospitals and particularly intensive care units (ICUs), have become centers for breeding and spreading antibiotic-resistant bacteria. This often delays effective therapy, requires costly patient isolation, increases mortality and length of hospital stays, and therefore large costs to the healthcare system.

In the global fight against severe infections, clinical experts, and local as well as global healthcare organizations are demanding new, easy to use solutions that make the rapid detection of infectious agents and potential resistances to antimicrobial drugs possible. These would enable timely and optimal antibiotic therapy decisions, for instance for healthcare related infections.

Infection can occur during or after the surgical procedure and usually results in a significant increase in the length of hospital stay and overall treatment costs. The risk of surgical site infection varies between patients, with risk factors including wound class, duration of operation, type of procedure and the type of anesthesia utilized. The health risk posed by such infection depends on whether the skin, deeper tissues or other structures are involved.

In the UK, at least 25% of surgical site infections reported during 1997-1999 were more serious deep or organ infections (PHLS SSI Surveillance). Post-operative surgical site infections remain a major source of morbidity and a less frequent cause of mortality in surgical patients. Approximately 500,000 surgical site infections occur each year in the US, following an estimated 27 million annual surgical procedures. However, the incidence of wound infections following surgery varies significantly with surgeon, hospital, procedure and patient.

Sepsis kills 1,400 people every day worldwide.

In the US, emergency departments treat in excess of 100 million patients each year and an estimate suggest that 2.9% of hospital admissions are associated with severe sepsis and septic shock. The incidence of sepsis continuous to rise increase by 1.5% per annum. Research has shown that mortality rate in sepsis patients is somewhere in the range of 28-50%.

Sepsis affects around 100,000 people in Germany each year and the cost of sepsis per patient is approximately € 23,297 leading to total healthcare costs in the region of € 1,025 million to € 2,214 million. Direct costs were found to be only 28% of sepsis disease burden, with indirect costs ranging between € 2 billion and € 5,6 billion.

Although sepsis is most commonly caused by some form of underlying infection, not all cases are associated with a positive culture. As reported by a US study, only 35% of 1,342 episodes of sepsis syndrome, resulted in a positive culture result. In the same study, only 32% of cases involved bacteremia and 32% involved a documented infection without bacteremia. This data indicates that the identification of the pathogen involved in sepsis is not as simple resulting in false-negative cultures in the range of 45%.

At present the identification of specific bacteria in sepsis typically requires 24 to 72 hours and, as a consequence, physicians must initiate broad-spectrum antibacterial therapy prior to pathogen identification. The lack of diagnostic information and associated broad-spectrum nature of treatment has severe implications for patient prognosis, cost of therapy and the development of resistant strains.

However, the incidence of wound infections following surgery varies significantly with surgeon, hospital, procedure and patient.

As in other bacterial infections there is a lack of diagnosis tests to timely provide the clinicians with clinically relevant information enabling adequate early antibiotic treatment.