Point-of-care Nucleic Acid Assays

Genomic and transcriptomic biomarkers have been identified that can be utilized for disease diagnosis, prognosis, and monitoring including cancers, cardiovascular health, depression, and sepsis. Genetic variations 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. Even though, there has been development in portable PCR machines, these still need skilled staff, power and are not rugged for battlefield environments. There is a clear need to develop assays and instruments that can be utilized at the site to rapidly detect and quantify specific sets of genes including SNPs from a variety of different clinical samples. To address this need, we propose to develop novel point-of-care assay kits for precise, multiplexed detection of genetic variation. The assays kits will be low-cost, support no to low power operation, and provide rapid results. Phase I will establish proof-of-concept of the assays by demonstrating detection of selected gene variants of interest from spiked samples. Phase II will expand the multiplexing capabilities of the assay and build pre-production prototypes.