Abionic receives IVDR certification for its ultra-rapid Sepsis test

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10.08.2022
Abionic Sepsis Test

Abionic’s test uses the earliest marker of sepsis, allowing for its identification up to 72 hours before the standard of care in 5 minutes. The newly IVDR certified PSP test is particularly useful for guiding physicians in the decision to start or modify antibiotic treatment.

Abionic SA, a developer of disruptive nanotechnology-based diagnostic solutions, has announced that its Pancreatic Stone Protein (PSP) test on the abioSCOPE has been certified by BSI certification agency as complying with the European In-vitro Diagnostic Regulation (IVDR), EU 2017/746. This certification granted by notified bodies like BSI is required for in-vitro diagnostics to continue being sold in the European Union.

Dr. Samir Vora, infectious disease physician, Geneva, Switzerland, commented: “The PSP assay has the potential to help the physician decide whether or not to start antibiotic therapy, and thus contribute to reducing the two major public health problems of sepsis and antimicrobial resistance.” Studies have shown that antibiotic therapy is incorrectly prescribed in as many as 60% of patients receiving hospital care and is likely to be even higher outside this environment (Luyt et al., Critical Care, 2014). Aside from contributing to resistance, inappropriate antibiotic use may lead to increased mortality and severe disease, increased healthcare costs, increased lengths of stay in hospital and the need for more complex treatments leading to a higher risk for adverse effects and unwanted drug interactions.

Expansion to the USA

Two years after the commercial launch of its sepsis test, Abionic’s expansion is reaching a global scale. With over 50 markets already covered, Abionic’s next big step is the U.S. where sepsis represents the single largest cost to the healthcare system. Clinical trials to support FDA 510(k) submission are well underway. “As we gear up for FDA clearance, it’s very motivating to see how excited the U.S. ecosystem is about our novel approach to detecting sepsis and its potential impact on lifespan and healthcare costs,” said Nelson Dumas, Director of the U.S. Subsidiary of Abionic.

(Press release / SK)

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