Fast susceptibility tests for personalised antibiotic treatment
Sepsis is a life-threatening condition that develops when the body’s response to infection, such as inflammation, results in its own organs and tissues being compromised. This leads to a weakened immune system and sometimes death. The only treatment currently availability to stop the disease progressing is the administration of emergency, broad-spectrum antibiotics. While these usually save lives, in up to 40 % of cases the specific treatment given is inappropriate, often a result of incorrect dosage or the use of the wrong kind of antibiotic. To get both right, clinicians must first identify the pathogen causing the infection, and test for the most effective antibiotic. “But the standard antibiotic susceptibility testing (AST) currently available takes 24 to 48 hours. Given the need to urgently respond to sepsis cases, this is simply too long to be effective,” says coordinator of the RAPID-SEP-AST project, Grzegorz Gonciarz. RAPID-SEP-AST’s host Resistell had already developed AST that delivers diagnostic results within two to four hours. This EU-funded project enabled the team to finalise the industrialisation, CE-IVD approval and proof of efficiency study necessary for commercialisation. “Thanks to the project’s excellent clinical data, despite the hospital and lab COVID-19 challenges, we have released our first product into the market,” remarks Gonciarz. “We already have the first pre-orders and are now working on the additional certifications required for our target markets beyond Europe, principally the United States and Japan.”
Taking a different approach
Before RAPID-SEP-AST, all the technologies, either under development or already available in the market, measured the bacterial growth rates when exposed to antibiotics, inevitably slowing down the results. “Instead, this Swiss Federal Institute of Technology invention measures bacterial vibrations, comparing how bacteria vibrate before and after exposure to the antibiotic being tested,” explains Gonciarz. Micromechanical sensors and a photo-detection system in Resistell’s solution measure the nanomotion of the bacteria. This microwave-sized benchtop system integrates well with standard workflows for sample preparation. The accompanying software then delivers a resistance/susceptibility report. Thousands of preclinical tests on anonymised patient isolates (bacterial sample collections) were performed at Resistell’s laboratories. “After the tests had achieved accuracy rates above 95 %, with a significantly reduced time-to-result, we then started our clinical studies,” says Gonciarz.
Improving outcomes, reducing costs
Annually, there are almost 50 million sepsis cases and around 11 million deaths worldwide, almost 700 000 of those within Europe, and the numbers are growing. “During the COVID-19 pandemic, sepsis was diagnosed in over 60 % of patients admitted to hospital,” adds Gonciarz. In the United States, sepsis is the most expensive condition for the American healthcare system, in 2013 equating to over USD 24 billion in hospital expenses. “With our solution, for the first time, clinicians will be able to deliver personalised antibiotics to sepsis patients the same day they are diagnosed, improving treatment outcomes. This will reduce hospital time and so overall medical costs,” concludes Gonciarz. Looking to the future, the team are considering development of the technology for other applications, such as antifungal susceptibility testing, personalised phage or cancer therapies. For now the team are concentrating on scaling up their commercial operations, leveraging pre-existing European global distribution channels, while developing new ones further afield.
Keywords
RAPID-SEP-AST, sepsis, antibiotics, infection, blood poisoning, bacterial, antibiotic susceptibility testing
