K. Liu, S. Du
NaMi Diagnostics,
United States
Keywords: cell deformability, early sepsis diagnosis, sepsis, rapid detection, neutrophil, electro-deformability spectroscopy, diagnostic
Summary:
Sepsis is a life-threatening condition that affects approximately 1.7 million adults each year in the United States, resulting in over 270,000 deaths and an estimated $38 billion in healthcare costs. Globally, there were 48.9 million cases and 11 million deaths attributed to sepsis in 2020. Without timely diagnosis and antibiotic treatment, sepsis leads to high morbidity and mortality and imposes a tremendous burden on healthcare systems, as patients often require prolonged hospitalization, with intensive care unit (ICU) stays of 2–3 weeks or longer. NaMi Diagnostics is a pre-clinical stage biomedical company developing next-generation sepsis diagnostics designed to deliver rapid confirmation of suspected sepsis, enable timely medical intervention, and improve patient outcomes. Since immune cells play a pivotal role in defending against microbial infection, unlike traditional methods that identify causative pathogens or rely on non-specific vital signs such as blood pressure, body temperature, and respiratory rates, our innovative approach focuses on the root cause of sepsis, the patient’s immune response to acute infection for early identification of the disease. In collaboration with Florida Atlantic University, the company is developing an Electro-Deformation Spectroscopy (EDS) platform capable of analyzing hundreds to thousands of immune cells, specifically neutrophils, within minutes. The system precisely captures the alternation in cell mechanical properties (i.e., cell membrane deformability) across large cell populations, which are triggered by the host inflammatory response. These pathological changes serve as highly sensitive and specific early biomarkers for sepsis. The system integrates a signal generator, a disposable microfluidic chip with microelectrode arrays, and an image acquisition module. Using an established assay protocol and proprietary image-processing algorithms, the test is expected to deliver near real-time diagnostic results, enabling prompt medical decisions. Other key advantages include ease of use, minimal sample and reagent requirement, low operational costs and skill demands, and strong point-of-care potential, making the technology and our future product particularly well-suited for ICU and emergency care settings, where most sepsis cases are managed. Data from our pre-clinical study reveal a significant difference (p < 0.05) in neutrophil deformability between blood samples from healthy donors and the in-vitro disease model and demonstrate detection of cytokine-induced inflammatory responses in 30 minutes, well within the time window recommended by current clinical guidelines for antibiotic administration in suspected sepsis, thereby supporting the clinical feasibility of identifying sepsis at its initial stage. NaMi Diagnostics is now preparing to launch a pilot clinical trial at St. Mary’s Medical Center in Q1 2026, aiming to recruit approximately 30 study subjects, including patients diagnosed with sepsis, non-infectious systemic inflammatory response syndrome (SIRS) patients, and healthy volunteers. This study will further assess the system’s ability to distinguish sepsis from non-infectious SIRS and to evaluate correlations between test results and patient outcomes (e.g., survival rates and ICU length of stay), supporting its application for disease severity assessment and risk prognosis in real-world medical settings.