SeptiLoop IVD LPS-Induced TNF-alpha Release Assay

Loop Diagnostics S.L.

Barcelona, Spain

Loop Diagnostics S.L. (Loop Dx): Revolutionizing Rapid Infection Diagnostics Loop Diagnostics is a Spanish-based IVD company that developed SeptiLoop, the first CE-IVDR Class C near-patient test that helps identify early immunosuppression induced by bacteremia, including sepsis. SeptiLoop also holds UKCA certification. Our uniqueness is the functional host-response approach. Instead of static serum markers, we stimulate whole blood ex vivo with LPS and quantify the patient s TNF-α release. This response assay detects immune dysfunction from first contact in the ED and through the first 72 hours of infection, with a simple workflow and a result in under 3 hours. Clinical studies in emergency settings showed 91 percent sensitivity and 80 percent specificity, with performance that compares favorably to conventional serum biomarkers for early detection. The technology has been evaluated in more than one thousand suspected sepsis patients across prospective feasibility and accuracy studies. Our near-term goal is to scale hospital adoption in Europe, embed SeptiLoop into ED and ICU pathways, and advance regulatory and market access in the UK, EU, and US. We are also extending the platform to new clinical uses using the same immune-response methodology. The challenge is accelerating the shift toward rapid functional testing that informs triage and early decision-making. Our vision is for dynamic immune assessment to become a standard pillar of acute infection management, reducing mortality, adverse effects, and unnecessary antibiotic use. Our Goals Accelerate Diagnosis : Reduce the time to diagnose bloodstream infections, enabling earlier intervention and improving patient outcomes. Enhance Precision : Increase the accuracy of infection detection to ensure patients receive the most effective treatments promptly. Improve Accessibility : Develop cost-effective diagnostic tools that can be easily integrated into clinical settings worldwide. Challenges We Tackle Sepsis Detection : Sepsis is a life-threatening condition that requires immediate attention. Our technology aims to identify sepsis at its earliest stages. Antimicrobial Resistance : By enabling precise diagnostics, we help reduce the misuse of antibiotics, combating the global issue of antibiotic resistance. Healthcare Efficiency : Providing rapid results can significantly reduce hospital stays and healthcare costs, optimizing resource allocation. Our Vision We envision a world where rapid and accurate diagnostics are accessible, leading to timely treatments and better healthcare outcomes. By bridging the gap between unmet clinical needs and innovative solutions, we strive to transform the landscape of medical diagnostics.