Nanotechnology diagnostic developer Abionic has completed a multi-centre observational study using its point-of-care Pancreatic Stone Protein (PSP) sepsis test on the abioScope platform.
The sepsis test performed on Abionic’s nanofluidic technology based point-of-care abioScope platform offers results in five minutes with a drop of capillary blood for the earliest detection of sepsis, enabling physicians to make critical decisions at the point of need.
The study was designed to establish performance characteristics of the PSP test in the early detection of sepsis. A total of 300 adult ICU patients at high risk of developing sepsis admitted to 14 ICU sites in the UK, France, Italy and Switzerland were enrolled. Bedside measurement of PSP on the abioScope clearly shows correlation with the onset of sepsis. During the study, the majority of patients who developed sepsis already showed high PSP concentration values 24 hours before the diagnosis with current methods.
The complete clinical data is currently in preparation for peer reviewed publication at the beginning of 2020.
Fabien Rebeaud, PhD, chief scientific officer of Abionic, said: “We are extremely proud to announce the successful completion of our pivotal sepsis trial and thank all the people who make this possible. Our study demonstrates that, from a drop of blood and in five minutes sepsis can be identified several dozen of hours upfront than today’s standard of care. This opens tremendous perspectives for the improvement of the diagnosis of sepsis and its timely, optimal clinical management, for the benefit of the patient.”
Abionic is about to launch a multi-centre clinical trial in the U.S with the aim of further establishing the clinical value and to fulfil FDA registration requirements. The first patient in is expected in October 2019.
Prof. Dr. Bruno François, principal investigator of the study from University Hospital Limoges, France, said: "I am deeply convinced of the potential of POCT with adequate sepsis marker that allows to speed up sepsis diagnosis. The PSP test on the abioScope platform is well positioned to achieve that ambitious but important goal."
To improve sepsis management and reduce its burden, in 2017, the World Health Assembly and World Health Organisation adopted a resolution that urged governments and healthcare workers to implement appropriate measures to address sepsis. The resolution determined that sepsis should be considered a medical emergency and that increasing the level of awareness of sepsis is essential.
Dr. Giuseppe Nardi from Rimini Hospital, Italy, who also participated in the study, added: “The burden of sepsis is rising globally and claims up to 9 million lives every year – every three seconds a person dies from sepsis. Abionic’s early sepsis recognition test may tackle this issue and bring a valuable contribution to the improvement of sepsis management.”
Abionic is about to launch a multi-centre clinical trial in the U.S to further establish clinical value and fulfill FDA registration requirements. The first patient in is expected in October 2019.
