STTR Phase I: Development of Biochip and Cartridge Components of a Rapid, Point-Of-Care, Diagnostic Technology Platform with the Diagnosis of Liver Cancer as the First Application

The broader impacts/commercial potential of this Small Business Technology Transfer (STTR) Phase I project lies in the area of personalized and preventative medicine. The proposed work is aimed at brining current laboratory-based blood/urine/saliva-tests, to the point-of-care, such as primary/urgent/emergency care facilities, community centers, and for some diseases, retirement homes, and self-testing. Current standard time-to-results, ranging from days or weeks, will be reduced to a few minutes, allowing for disease screenings during routine physician visits resulting in early-diagnosis and improved treatment monitoring. It will promote preventative care, and therefore lead to improved treatment outcomes, patient satisfaction, and eventually reduced healthcare costs. This work will result in the development of a portable, low-powered, hand-held device that can be operated in-the-field, in low-resource settings, here in the US and internationally, thus supporting better health management in these under-served communities. This unique technology has the potential to further improve the current standard of care by reliably and reproducibly detecting multiple diseases from the same few drops of blood in a few minutes. Although a single disease, liver cancer, is the initial target, future generations will target diseases ranging from cancers to viral and bacterial infections and can be expanded to environmental and veterinarian applications. The proposed project aims to develop a proprietary multimodal approach (essentially lab-on-chip) that will translate the entire laboratory based diagnostic testing procedure to a rapid and disposable point of care test. The challenge lies in low sample volume availability (few drops), complex sample type (unprocessed whole-blood), short time-to-results (15 minutes) and need for high accuracy and reliability. To address these stringent requirements, Advanced Biosensors is developing a platform technology based on a unique combination of label-free, very high frequency piezoelectric biochips, magnetic nanoparticles, and microfluidics. During this Phase I, key technology component designs and specifications that are required for the point-of-care detection of 1-1500ng/mL Alpha Fetoprotein with performance (sensitivity, linearity, and dynamic range) comparable to the current gold standard centralized laboratory method, i.e. ELISA, will be developed. At the end of this Phase I project, the critical designs of individual cartridge components will be fabricated and tested. These components will serve as critical inputs to the integrated prototyping to be performed in phase II that will result in a portable point of care diagnostic device.