Abionic SA | MedPath

FDA Approves Abionic's CAPSULE PSP for Early Sepsis Detection; Fapon to Commercialize in China

7 months ago

• Abionic's CAPSULE PSP, an early sepsis detection test, has received FDA 510(k) clearance, marking a significant advancement in sepsis diagnosis. • The test utilizes Pancreatic Stone Protein (PSP) as a biomarker, detecting sepsis 24-48 hours earlier than current standard methods, improving patient outcomes. • Fapon has secured exclusive rights to commercialize the PSP biomarker for sepsis diagnosis in China through a strategic partnership with Abionic SA and LASCCO SA. • Fapon will develop and commercialize the PSP test on its chemiluminescent immunoassay (CLIA) analyzer, expanding its diagnostic solutions portfolio.

Abionic's CAPSULE PSP Receives FDA Approval for Early Sepsis Detection

7 months ago

• Abionic's CAPSULE PSP, an innovative test for early sepsis detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). • The CAPSULE PSP test measures Pancreatic Stone Protein (PSP), a biomarker that rises in response to infections and inflammation, enabling earlier sepsis detection. • Fapon has secured exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China through a strategic partnership with Abionic SA and LASCCO SA. • Fapon is developing and commercializing PSP on its chemiluminescent immunoassay (CLIA) analyzer for the Chinese market, leveraging the FDA approval and strategic collaboration.

FDA Approves Abionic's CAPSULE PSP for Early Sepsis Detection

7 months ago

• Abionic's CAPSULE PSP, an innovative in vitro diagnostic test for early sepsis detection, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). • The CAPSULE PSP test measures Pancreatic Stone Protein (PSP) levels, an emerging biomarker that can detect sepsis 24-48 hours earlier than current standard methods. • Fapon has exclusive rights to utilize the PSP biomarker for sepsis diagnosis in China, leveraging a strategic partnership with Abionic SA and LASCCO SA. • Clinical studies demonstrate that elevated PSP levels correlate with sepsis progression, enabling earlier intervention and potentially improving patient outcomes.