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Abionic, a medical diagnostics company specializing in rapid early detection technologies, announced that its IVD CAPSULE PSP test has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expedite sepsis detection. Already certified under the EU IVDR as of July 2022, this FDA clearance represents a key milestone in Abionic’s entry into the U.S. market

Sepsis is a global health emergency, impacting 50 million people worldwide and responsible for 11 million deaths—20% of all global mortality. In the U.S. alone, it affects 1.7 million patients and incurs an annual cost of $38 billion, making it a significant public health concern. Timely intervention is critical, as sepsis is a rapidly progressing condition. According to the Sepsis Alliance, 80% of sepsis-related deaths could be prevented with early detection and intervention. However, sepsis remains difficult to diagnose due to its non-specific symptoms, which often mimic other common conditions. Early identification is essential for initiating effective treatment and improving patient survival rates.

Pancreatic Stone Protein (PSP) is an emerging biomarker used by clinicians to detect sepsis 24-48 hours earlier than current methods, aiding in time-sensitive decision-making. Produced by the pancreas and immune cells, PSP levels rise in response to infection and inflammation, and have shown high sensitivity and specificity in sepsis detection, particularly in critically ill patients. Clinical studies demonstrate that elevated PSP levels are closely linked to sepsis progression, enabling healthcare providers to implement sepsis treatment protocols sooner and improve outcomes.

The IVD CAPSULE PSP test is designed to work exclusively with the abioSCOPE®, an award-winning rapid diagnostics platform that utilizes nanofluidics to deliver lab-quality results from a drop of blood in just minutes. Seamlessly integrated into standard clinical workflows, the test provides fast, accurate, and user-friendly results in critical care settings. By measuring PSP levels, which are directly associated with a patient’s sepsis risk, the test empowers clinicians to make informed decisions and initiate appropriate treatments earlier, ultimately improving patient outcomes.

“Achieving FDA 510(k) clearance for IVD CAPSULE PSP marks a significant milestone for Abionic and confirms our ability to meet the need for quick & reliable sepsis testing,” said Patrick Pestalozzi, CEO at Abionic. “This clearance will allow us to deploy our solutions across the United States and provide clinicians in acute care settings with a proven solution to accelerate the Time-To-Detection of sepsis.”

Source: Business Wire