The proposed Phase I SBIR project will support Sandstone Diagnostics, Inc. to demonstrate feasibility of a commercial point-of-care diagnostic system for rapid diagnosis and monitoring of neonatal sepsis using peripheral protein and cellular biomarkers from heel stick blood samples in the NICU. Significance: Neonatal sepsis affects approximately 4 out of every 1000 live births and accounts for nearly half of all neonatal deaths in the United States. Detection of the onset of sepsis and timely intervention with appropriate antimicrobial therapy is critical for survival in neonates. There is an urgent need for improved early diagnostic tools;routine laboratory blood culture (gold standard) suffers from slow analysis time (24 - 48 hours), large sample volume requirement (~1 mL), and high false negative rate. Innovation: Our patent-pending SpinDxTM system uniquely addresses this need by achieving rapid (~15 minute), multiplexed quantitation of protein and cellular biomarkers from small volume (~30 ?L) whole blood samples. All assays are packaged on one disposable microfluidic disk for fully automated analysis in a portable, battery-powered reader. Approach: We will demonstrate feasibility by: (1) developing assays for a panel of protein and cellular biomarkers shown to be responsive for early detection and monitoring of neonatal sepsis, and (2) packaging and deploying a system to the Stanford Clinical Laboratory for follow-up (Phase II) benchmarking and validation using whole blood samples obtained for routine monitoring in the Lucile Packard Children's Hospital NICU. Target biomarkers include acute phase reactants (CRP, PCT, SAA, LBP), chemokines and cytokines (IL-6, IL-8, TNF?), hematologic parameters (WBC counts) and cell surface antigens (CD64, CD11b, HLA-DR, CTLA-4). The system is designed for fully automated quantitation of each biomarker from blood samples loaded via pipette or interfaced with heel stick collection tubes commonly used in the NICU. Company: Sandstone Diagnostics, Inc. was founded in April 2012 in Livermore, CA. Company co-founders Schaff and Sommer invented the SpinDxTM technology at Sandia National Laboratories for point-of-care biodefense applications, including NIH U01 funding for an improved toxin diagnostics system. The company has licensed the intellectual property from Sandia for neonatal diagnostic applications. The company's lead advisors have deep executive experience in diagnostic product development, marketing, and FDA clearance. Sandstone is also partnering with Dr. James Faix - a premier thought leader in sepsis diagnostics and management at Stanford University Medical Center. Commercial Market and Customers: The final product will greatly enhance neonatal and pediatric sepsis monitoring capabilities by drastically reducing the time, cost, and sample volume required for testing and diagnosis. The company has received extensive interest and feedback from NICU physicians, nurses, and laboratory personnel who constitute our targeted customer base. The company anticipates penetration into the estimated $1.5 billion global clinical neonatal and pediatric monitoring market within 4 years.
The proposed device facilitates rapid diagnosis of neonatal sepsis, and infants at risk at advancing to severe sepsis, by measuring a broad panel of protein and cellular biomarkers from heel stick whole blood samples. The final product will greatly enhance NICU monitoring capabilities, enabling timely and directed therapeutic intervention. Sepsis is a major public health concern accounting for nearly half of all neonatal deaths in the United States.