Chinese pharma company secures exclusive licence with Abionic and Lascco

By leveraging their respective expertise in technology, medicine and market, Biopole-based companies Abionic and Lascco and China-based life sciences company Fapon will join forces in the rapid screening and clinical diagnosis of sepsis, as well as providing guidelines for antibiotic use. Sepsis is a life-threatening condition caused by a dysregulated host response to infection, which can progress to multiple organ dysfunction, septic shock and even death. Current methods to detect early warning signs and symptoms cannot meet the clinical needs for early diagnosis of sepsis as they have major limitations.

Based on Abionic’s abioSCOPE device, LASCCO developed a Pancreatic stone protein (PSP) test for the prediction of sepsis outcome. PSP is an acute-phase protein secreted by pancreatic acinar cells, with levels that correlate with the presence and severity of sepsis. Sufficient evidence has shown that PSP exhibits great accuracy as an early warning sign of sepsis. The PSP level in the blood shows a significant upward trend three days before the clinical diagnosis of sepsis, even in inflammatory confounding situations such as sterile inflammation and inhalation injury in burnt patients or post-trauma and post-surgery inflammatory host responses.

In 2022, the PSP immunoassay obtained CE mark approval under the In Vitro Diagnostic Medical Devices (IVDR) regulations, Australian registration. Since then, the PSP test has been commercially deployed in 20+ countries and is widely used to diagnose ICU patients in several European hospitals, providing clinicians with a clear result in all at-risk patients in 5 minutes. Abionic is in final preparation for the 510(k) clearance with the FDA in the United States.

The strategic partnership and exclusive licence allow Fapon to engage in the research, development, manufacturing, and commercialization of PSP raw materials and chemiluminescent immunoassay (CLIA)-based reagent solutions within the Chinese market. The financial terms of this transaction have not been disclosed.

Fapon is dedicated to advancing the discovery and research of innovative biomarkers to accelerate the transition of such markers to clinical applications. Obtaining the PSP license for the diagnosis of sepsis will further enhance Fapon's potential for innovative applications in the diagnosis of infectious diseases.

(Press release / RAN)