This PFI: AIR Technology Translation project focuses on translating an integrated microfluidic device capable of processing milliliters of whole blood by rapidly isolating and enriching rare cells (such as circulating tumor cells, CTCs), resulting in faster sample preparation for high fidelity diagnostic and prognostic measurements that are critically needed in many therapeutic applications. This integrated microfluidic platform is important due to the direct impact on cancer patients and supporting infrastructure resulting from bringing this game-changing microfluidic device to market. Patient diagnosis and monitoring would become simpler, cheaper, faster, and more convenient. Moreover, the usage of this microfluidic platform is not limited to cancer diagnosis, but extends to any disease or condition measured via changes in cellular physical properties in a sample of biological fluid. The project will result in an optimized, integrated cell separator and enrichment prototype microfluidic device. The team will demonstrate its utility with clinically relevant levels of CTCs in whole blood to determine its feasibility for improved cancer diagnosis and monitoring. This integrated microfluidic device has the following unique features: (a) label-free cell separation, enrichment, and release, (b) clinical scale sample volumes and single pass through device to achieve complete cell isolation and enrichment (100% target capture) in approximately 20 minutes, and (c) device is amenable to mass production. When compared to the leading competing methods for CTC isolation and purification from whole blood in this market space, these features provide the following advantages: (a) simpler operation, (b) quicker, more reliable test results, and (c) lower cost per test and small form factor towards a potentially portable system for use in various point-of-care applications or resource limited settings.
The main technology gaps to be addressed during the project are associated with optimizing the microfluidic device to achieve the rigorous performance levels required for CTC analysis (isolate and enrich 5 CTCs/7.5mL whole blood for downstream detection). These gaps will be bridged by having multiple integrated microfluidic devices working simultaneously in parallel and improving the sensitivity of the device to sufficiently separate and capture cells of similar size. In addition, personnel involved in this project, especially undergraduate students, graduate students, and post-docs, will gain innovation and technology translation experiences. They will become well versed in microfluidic cell sorting, enrichment, chip design, manufacturing, and the needs of primary end-users in multiple business spaces around the world. They will also gain firsthand experience in working in a multidisciplinary academic-industrial environment.
