A NANOeSPRi-based IVD Assay for Multiple Organ Injury

Major organ injuries 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 enhanced surface plasmon resonance imaging based diagnostic technology to detect all predictive biomarkers for organ injuries. It incorporates protein and aptamer arrays for detection of each biomarker with LoD as low as few pg/mL, used in a fieldable detection system. During the three-phase program, Luna has developed a proposed multiplexed assay and demonstrated its feasibility through detecting two organ injury biomarkers at pg/mL concentration in Phase I. 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. The project will result in a diagnostic product that will determine whether a patient have organ injury, thereby allowing the possibility to take early curative intervention.