Point-of-Care Nucleic Acid Assays

Precision medicine promises to improve many aspects of health and healthcare, making it possible for physicians to choose the best treatment and prevention strategy for each patient. Prior research has demonstrated that genomic and transcriptomic biomarkers are useful for disease diagnosis, prognosis, and monitoring, including cancers, cardiovascular health, depression, sepsis, etc. Genetic variations and differences in gene expression levels have also been identified that affect pharmacokinetics as well as pharmacologic effects of specific drugs. Current methods for detection and quantification of these nucleic acid biomarkers requires bulky equipment and trained laboratory personnel, with turnaround times ranging from few hours to several days. A low resource cartridge is required to identify clinically relevant genes including SNPs for these applications. Proof-of-concept for such a no-power cartridge for genotyping was demonstrated in Phase I. The Phase II work will focus on further improvement of the no-power cartridge design to include additional genotyping targets as well as transition to low-volume manufacturing. The fabricated cartridges will be extensively tested and characterized against human samples. Storage and environmental testing will be carried out to evaluate cartridge performance in real-world applications.