Abionic: International Pivotal Study Successfully Demonstrates Diagnosis of Sepsis within 5 Minutes – 24 Hours Earlier Compared with Current Standard-of-Care
Biopôle, Lausanne, Switzerland, -- Abionic SA, a developer of disruptive nanotechnology based rapid diagnostic solutions, announced today the successful completion of its multi-center observational study using Abionic’s novel point-of-care Pancreatic Stone Protein (PSP) sepsis test on the abioSCOPE® platform. The results of the study show an anticipation of 24 hours for the diagnosis of sepsis compared to current standard of care.
Abionic is engaged in an ambitious clinical program demonstrating how the PSP test could lead to a better recognition and clinical management of sepsis.
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. Time being critical with this condition, the outcome for patients could dramatically be improved with a gain of 24 hours.
The complete clinical data is currently in preparation for peer reviewed publication at the beginning of 2020.
“We are extremely proud to announce the successful completion of our pivotal sepsis trial and thank all the people who make this possible.” said Fabien Rebeaud, PhD, Chief Scientific Officer of Abionic. “Our study demonstrates that, from a drop of blood and in 5 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.”
“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,” Prof. Dr. Bruno François, Principal Investigator of the study from University Hospital Limoges, France, commented.
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 3 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-center clinical trial in the U.S to further establish the clinical value and fulfill FDA registration requirements. The first patient in is expected in October 2019.
The company’s vision is to have an abioSCOPE® in every single Intensive Care Unit (ICU) and Emergency Room (ER) to bring the right diagnosis immediately to patients.
Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Infection leading to sepsis can be bacterial, fungal, or viral, but usually 95% of cases are caused by bacteria.3
Sepsis is a global health crisis. It affects 27 to 30 million people every year, 7 to 9 million die – one death every 3 seconds. Depending on country, mortality varies between 15 and more than 50%. Many surviving patients suffer from the consequences of sepsis for the rest of their lives.4,5
Mortality increases 8% every hour that treatment is delayed. If diagnosed with sepsis and treated in the first hour, the patient has more than 80% survival rate.6,7
To improve sepsis management and reduce its burden, in 2017, the World Health Assembly and World Health Organization 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.