In response to the growing threat posed by antibiotic resistance, Curetis has developed Unyvero, a fully automated rapid diagnostic solution.
Antibiotic resistance is prominently acknowledged as a global crisis, attributed to the widespread overuse and misuse of antibiotics. There is a direct relationship between antibiotic consumption, and emergence and dissemination of bacterial resistances. Studies demonstrate that in 30-50% of cases, either treatment indication, agent choice or duration of antibiotic therapy is incorrect.
A survey in 2011 of infectious disease specialists, conducted by the Infectious Diseases Society of America (IDSA) Emerging Infections Network, found that more than 60% of infectious specialists had seen a pan-resistant, untreatable bacterial infection within the previous year. In addition, 30-60% of the antibiotics prescribed in intensive care units were found to be unnecessary, inappropriate or suboptimal.
Bacterial infections are challenging because they can be life-threatening, especially in hospitalised patients. This requires immediate initiation of antimicrobial therapy. However, conventional microbiological methods can take several days to return definitive results. Consequently, empiric treatment can be inadequate because information on the causative pathogen and its resistances is not available in time. Earlier identification of the pathogen and its antimicrobial resistances is an effective solution, allowing earlier informed treatment decisions to the benefit of patients and a more stringent use of antibiotics.
In 2006, ISDA released a 'hit list' of the six most dangerous drug-resistant microbes as pathogens of particular concern. A decade later, these superbugs have become more prevalent and pose a significant threat, as there are no effective antibiotics against them. At the top of the list are Gram-negative pathogens Acinetobacter baumannii and Pseudomonas aeruginosa, and the bacteria known as carbapenem-resistant Enterobacteriaceae (CRE). CRE is a class of drug-resistant bacteria that can even withstand carbapenems, last-resort drugs only administered after all other antibiotics have failed. Carbapenems are crucial in life-threatening infections such as lower respiratory tract (LRT) infections and intra-abdominal infections (IAIs).
LRT infections are a persistent and pervasive healthcare problem worldwide, and severe cases require hospitalisation. The etiology of LRT infections plays a key role in decision-making regarding the choice of antibiotics, isolation and hospitalisation measures. Gram-negative bacteria are the most commonly implicated organisms in LRT infections. Therefore, accurate and early diagnosis is essential for appropriate treatment, helping to minimise complications and improve outcomes.
Complicated IAIs are also a common health problem. In Germany, there are about 150,000 cases of severe IAIs a year. In the US, appendicitis alone affects about 33,000 patients annually and is responsible for over a million hospital days. One in four cases of severe sepsis or septic shock can be attributed to IAIs, and independent studies show an overall mortality rate of 7.5%.
Prompted by the dramatic rise in antibiotic resistance, Curetis has been at the forefront of developing rapid diagnostic solutions to address the unmet clinical need for reliable and rapid identification of potentially causative organisms and their associated resistance genes.
The Unyvero system is fully automated and has a broad range of differentiated multiplex molecular diagnostic panels, which enable detection and identification of a comprehensive list of common pathogens and their associated resistance markers in under five hours. Unyvero is based on proven PCR technology, and its self-contained disposable cartridge is prefilled with all necessary reagents that integrate automated nucleic acid extraction, amplification and detection.
"We wanted to offer a fast, reliable and practical solution that does not require highly qualified laboratory personnel. Our Unyvero system is fully automated so that it can always be operated correctly, even at the end of a long, exhausting night shift," says Oliver Schacht, CEO of Curetis.