The objective of this Phase I SBIR proposal is the development of a non-invasive, disposable biochip for the analysis of a panel of breast cancer biomarkers (c-erbB-2 and CA15-3) from saliva. The disposable biochip uses fluorescent immunoassay on a nano-magnetic bead platform to detect the biomarkers. The biochip is fabricated using BioMEMS technology to develop low-cost plastic biochips with integrated saliva sampling and smart passive microfluidic control. The concentration of the breast cancer biomarkers (in saliva) chosen for this work shows good correlation with breast cancer and can distinguish between benign and malignant tumors. The nano-magnetic bead platform is a versatile approach, which allows for separate detection limits for different biomarkers on the same biochip to ensure high sensitivity and specificity for breast cancer diagnosis. Furthermore, the nanomagnetic bead approach also makes it possible to adapt the biochip for detecting a new set of biomarkers without any microfluidic design changes. The integration of the magnetic bead approach (for fluorescent immunoassay) with the BioMEMS technology will allow us to develop a highly sensitive breast cancer biomarker detection chip, which can detect biomarkers across a broad dynamic range from ultralow (~ 5 -10 microliter) saliva volumes. The ultimate goal of this work is to develop a smart disposable biochip for screening a panel of breast cancer biomarkers for home healthcare use. Specific goals of the Phase I are: 1) Develop and demonstrate c-erbB-2 and CA15-3 detection using fluorescent immunoassay on magnetic bead platform. 2) Develop microfluidic biochip for capillarity based sampling of saliva with smart microfluidic control. 3) Integrate nano-magnetic bead immunoassay with smart microfluidic biochip for proof-of-concept demonstration of breast cancer biomarker panel detection.
