FDA Clears Abionic’s IVD CAPSULE PSP for the Early Detection of Sepsis

Abionic, an innovative medical diagnostics company specialising in rapid early detection technologies, has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its IVD CAPSULE PSP test.

Abionic, an emerging medical diagnostics company focused on rapid early detection technologies, received 510(k) clearance for its IVD CAPSULE PSP test 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.

Sepsis is a global health threat affecting 50M patients worldwide and responsible for 11M deaths, or 20% of all global deaths. In the United States, it strikes 1.7M patients and costs $62B annually, making it a major public health challenge (www.sepsis.org). 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. Timely detection and intervention are critical, as delayed antibiotic therapy in septic shock increases mortality by 8% per hour (Ventura et al. 2023). The current Sepsis-3 definition emphasises organ dysfunction measured by SOFA score (Singer et al. 2016). However, sepsis symptoms are non-specific, complicating early diagnosis (Fidalgo et al. 2022).

Biomarkers are increasingly used for personalised care in sepsis management (van Engelen et al. 2018; Singer 2019), but most biomarkers lack the necessary specificity

and speed for reliable sepsis detection (Rhee et al. 2016). This leads to frequent misdiagnosis, with over 40% of patients potentially being misdiagnosed, which contributes to the overuse of broad-spectrum antibiotics and exacerbates antimicrobial resistance (Klein et al. 2015). Common biomarkers such as C-reactive protein (CRP) and procalcitonin (PCT) help identify infections but are limited in predicting sepsis severity and outcomes.

Pancreatic Stone Protein (PSP) has emerged as a promising biomarker for sepsis diagnosis and outcome prediction (Zuercher et al. 2023; Fidalgo et al. 2022). PSP, a 144-amino acid glycoprotein secreted by the pancreas, plays a crucial role in the neutrophil response during sepsis (Eggimann et al. 2019). Its diagnostic potential has been validated in emergency departments (EDs) and intensive care units (ICUs) (Prazak et al. 2021).

PSP levels increase earlier in the infection process than traditional biomarkers, offering the potential for earlier sepsis detection at patient presentation. This early detection is especially beneficial in EDs, where PSP aids in early diagnosis, reducing unnecessary antibiotic use and supporting stewardship strategies (Fidalgo et al. 2022).

PSP also serves as a reliable prognostic marker for ICU mortality, outperforming CRP and matching PCT in predictive power (Zuercher et al. 2023). Its use in assessing severity and predicting mortality in septic patients allows for better resource allocation and patient stabilisation.

A key advantage of PSP is the availability of point-of-care (POC) tests, which enable rapid, cost-effective bedside measurements within minutes (Schneider et al. 2022). This quick turnaround is vital in high-stakes environments such as the ED and ICU.

The IVD CAPSULE PSP runs exclusively on the abioSCOPE®,an award-winning rapid diagnostics platform that leverages nanofluidics to deliver lab-quality results from a drop of blood within minutes. Seamlessly integrated into clinical workflows, measuring PSP levels, which are directly linked to a patient’s risk of sepsis, enables healthcare professionals to activate sepsis bundles earlier and improve patient health outcomes.

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Key Points

• Septic shock is a severe, life-threatening response to infection, characterised by systemic inflammation, tissue hypoperfusion, and persistent, severe hypotension.
• According to the Surviving Sepsis Campaign (SSC) guidelines, the recommended treatment to address hypotension in septic shock includes adequate fluid resuscitation and vasopressor support.
• Three recent retrospective observational studies have investigated predictors for a response to the addition of vasopressin.
• Studies indicate that patients who respond to the addition of vasopressin have lower mortality, reduced need for renal replacement therapy, and decreased catecholamine doses.
• The results of these studies suggest that vasopressin as an early adjunct to norepinephrine for patients with septic shock could be beneficial to patient outcomes.

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Point-of-view articles are the sole opinion of the author(s) and are part of the ICU Management & Practice Corporate Engagement or Educational Community Programme.