A NANOeSPRi-based IVD Assay for Multiple Organ Injury

Major organ injury such as liver, kidney, heart and lung injuries can lead to high morbidity and mortality in critically ill patients. Advanced noninvasive testing with high sensitivity and specificity is needed to detect specific organ injury particularly at early stages. Current techniques such as PCR, MS, absorption-based assays, ELISA and microfluidic-Luminex, cannot meet such requirements. To address this issue, Luna is developing an enhanced surface plasmon resonance imaging based diagnostic technology to detect predictive biomarkers for organ injury. It incorporates a protein array for detection of biomarkers with LoD as low as few pg/mL, and can be used in a fieldable detection system. During the three-phase program, Luna plans to develop the proposed assay and demonstrate its feasibility through testing with recombinant biomarkers in Phase I. The biomarkers and their cut-off values will be determined for the accurate diagnosis of organ injury. During Phase II, the assay kit will be further optimized, prototyped and validated with clinical relevance, followed by transitioning to manufacturing and commercialization for dual applications in Phase III.