Research & Development
Abionic Integrates First Patients in US Clinical Trial for Sepsis Diagnosis Method
13 January 2020 - - Swiss medtech firm Abionic SA is initiating a pivotal clinical trial in the US for an innovative point-of-care diagnostic method for sepsis to validate the results of a first trial that took place in Europe in 2019, proving the suitability of Abionic's sepsis test on the abioSCOPE device to identify sepsis, the company said.

The PSP test on the abioSCOPE can diagnose sepsis 24 hours earlier than TODAY's standard of care for sepsis diagnosis. For the US version of the study, the first patients are now being integrated.

The study will be held in seven leading hospitals: Rhode Island Hospital in Providence, RI, Baystate Medical Center in Springfield, MA, Rush Medical University in Chicago, IL, and the Mercy Health clinics Saint-Vincent, Saint-Anne, and Saint-Charles, all located in Toledo, OH.

The trial will support an FDA 510(k) filing. The goal of the study is to assess the performance of immunoassay measurements of pancreatic stone protein performed on Abionic's abioSCOPE device.

As indicated by earlier studies, PSP is the best marker to distinguish sepsis from non-infectious inflammation. The US study therefore seeks to confirm the results of the previously conducted European trials that found the PSP test on the abioSCOPE is able to recognize sepsis earlier than other markers.

Of the 30m people that are affected by sepsis each year, nine m cases are fatal. Unfortunately, sepsis symptoms are often unclear and unspecific.

This results in sepsis being overlooked or recognized too late, as mortality increases by ~ 8% per hour the treatment is delayed.

Current methods can take up to 48 hours to diagnose sepsis, meaning that vital time is lost, and survival chances diminish. Moreover, sepsis is also extremely costly for healthcare organizations: in the US alone, sepsis-related costs in hospitals surpass USD 24bn annually.

abioSCOPE delivers results in as little as five minutes, allowing immediate administration of effective treatment and thus reducing mortality. This also allows for lower costs for healthcare organizations.

Sepsis is a life-threatening organ dysfunction caused by a dysregulated host response to infection. Infection leading to sepsis is mostly bacterial, but can be fungal or viral as well.

Sepsis is a global health crisis, affecting 27 to 30 m people every year. 7 to 9 m of sepsis patients die one death every 3 seconds. Depending on the country, mortality varies between 15% and more than 50%.

Mortality increases 8% every hour that treatment is delayed. If sepsis is diagnosed and treated in the first hour, the patient's chances of survival exceed 80%.

Founded in 2010, Abionic is a Swiss Medtech company that has developed a revolutionary nanofluidic technology, providing healthcare professionals with a fast, simple and universal diagnostic tool.

Abionic's cutting-edge Nanotechnology enhances efficiency and versatility of standard ELISA tests to deliver optimal point of care treatment options with the potential to reduce the current biological techniques from macroscale to nanoscale in a multi-analyte environment.

Abionic's In Vitro Diagnostic platform provides lab-quality results in 5 minutes from a single drop of blood at the POC enabling personalized diagnostics and the possibility of immediate treatment initiation. Other certified products already exist in allergy and iron deficiency TODAY allowing for exploration of other targets for the IVD market of tomorrow.

The abioSCOPE relies on Nanofluidics. Nanofluidics is the study of a liquid's behavior at the nanoscale. In such dimensions, it is possible to take advantage of the 'forced' biomolecular interactions happening in the nanospace in order to develop immunoassays able to detect minute concentrations of analyte in complex matrices such as blood.

This allows for an immunoassay that quantifies pancreatic stone protein from a drop of capillary whole blood in as little as 5 minutes. The specimen is mixed with a solution containing the fluorescently labelled detecting antibody.

It then passes through a nanometric size channel in which anti-PSP antibodies are immobilized. These antibodies capture the PSP bound to the fluorescent detecting PSP antibodies.

The abioSCOPE, a tabletop size, easy-to-operate device, reads the fluorescence emission from the PSP sensor and converts the signal, employing advanced signal processing, into a concentration thanks to the assay's embedded, lot-specific calibration.
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