Summary: Abionic’s IVD CAPSULE PSP test gained FDA 510(k) clearance to rapidly detect sepsis, marking the company’s expansion into the U.S. market.

Takeaways:

  1. The IVD CAPSULE PSP test provides early detection of sepsis, identifying it 24 to 48 hours earlier than standard methods using the Pancreatic Stone Protein (PSP) biomarker.
  2. Sepsis remains a global health crisis, with over 50 million cases annually, and early detection is crucial to prevent millions of deaths, especially in critical care settings.
  3. Abionic’s FDA clearance enables U.S. deployment of its rapid diagnostic test, which operates on the abioSCOPE platform, delivering lab-quality results from a single drop of blood within minutes.

Abionic, an emerging medical diagnostics company focused on 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 accelerate the time-to-detection of Sepsis. Already certified under the EU IVDR as of July 2022, this FDA clearance marks a pivotal moment for Abionic’s expansion into the U.S. market.

Impact of Sepsis

Sepsis is a global health threat affecting 50 million patients worldwide and responsible for 11 million deaths, or 20% of all global deaths. In the United States, it strikes 1.7 million patients and costs $38 billion annually, making it a major public health challenge. Sepsis is a time-sensitive emergency and according to the Sepsis Alliance, 80% of sepsis-related deaths could be prevented, but it remains notoriously difficult to diagnose due to the non-specific nature of its symptoms, which often resemble those of other common conditions. The timely and early detection of sepsis is critical to initiate optimal treatment protocols and increase the odds of patient survival.

Pancreatic Stone Protein (PSP) Biomarker

Pancreatic Stone Protein (PSP) is an emerging sepsis biomarker used by clinicians as a screening tool for the early-detection of sepsis 24 to 48 hours earlier than current standards to support critical time-sensitive decisions. Produced by the pancreas and immune cells, PSP levels increase in response to infections and inflammation and has demonstrated significant sensitivity and specificity in detecting sepsis, particularly in critically ill patients. Clinical studies have shown that elevated PSP levels correlate closely with the progression of sepsis, allowing healthcare professionals to activate sepsis bundles earlier and improve outcomes.

The IVD CAPSULE PSP runs exclusively on the abioSCOPE, a rapid diagnostics platform that leverages nanofluidics to deliver lab-quality results from a drop of blood within minutes. Seamlessly integrated into routine clinical workflows, the test delivers fast, accurate, and user-friendly results in critical care settings. By measuring PSP levels, which are directly linked to a patient’s risk of sepsis, the test enables clinicians to make informed decisions and initiate appropriate treatments earlier, improving outcomes.

Further reading: AI Enables Effective Antibiotic Treatment of Sepsis

“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,” says 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.”