SBIR Phase II: Development of a Rapid, Point-Of-Care, Diagnostic Technology Platform with the Diagnosis of Liver Cancer as the First Application

This Small Business Innovation Research (SBIR) Phase II project aims to develop a platform technology for point of care (POC) detection of disease biomarkers present in low concentrations in bodily fluids. This technology can greatly impact the current standard medical workflow by reducing the time-to-results from days or weeks to 15 minutes, allowing for disease screenings during routine doctors visits supporting early diagnosis and improved treatment monitoring. It will promote preventative care, and therefore lead to improved treatment outcomes, patient satisfaction, and reduced healthcare costs. This technology will be incorporated into a portable, low-powered device that can be operated in-the-field, in low-resource settings in the US and internationally, supporting better healthcare monitoring that is often absent in under-served segments of society. The first target application is the detection of liver cancer, a disease that, when diagnosed late, has an extremely high mortality rate and cost of treatment. The proposed system may aid in the screening and early diagnosis of liver cancer. Furthermore, due to the technology?s inherent potential for multiplexing, it may be possible to simultaneous detect multiple biomarkers for chronic liver disease (Hep B, C, and cirrhosis), increasing its applicability to a global patient pool of over 500 million patients. Medicine is increasingly focused on personalized and preventative care and hence there is an increasing demand for diagnostic tools that can facilitate rapid screening, diagnosis, and treatment monitoring. Most current POC tests on the market are lateral flow based and do not target high sensitivity applications like cancer biomarkers, which require quantitative results and are present in low concentrations in blood. The goal of this Phase II project is to develop a standalone diagnostic system consisting of a portable reader and disposable cartridges to rapidly diagnose hepatocellular carcinoma (HCC) via the quantitative detection of AFP. During year 1, a 20-sensor very-high frequency (VHF) biochip will be designed and fabricated, simultaneously the whole blood processing component of the cartridge will be developed and integrated to form an all-inclusive cartridge. A distributed standalone electronic system will also designed and tested in year 1. Year 2 will involve the integration of the reader components to form a standalone system, additionally the all-inclusive cartridge will modified to interface with the reader allowing for plug and play operation. The performance of the integrated system will be evaluated via detection of HCC biomarkers in registry samples and comparison to the current standard of care.