SBIR Phase I:Sub-Cellular Tunable Confocal MEMS Scanner for Early Cancer Detection

This Small Business Innovation Research (SBIR) Phase I project proposes to develop a handheld sub-cellular confocal microscope using Micro-Electro-Mechanical systems (MEMS) technologies for non-invasive and early detection of cancers. 85% of cancers arise in epithelium and occur in the topmost 200 microns of tissues, including oral, skin, cervical, and many other cancers. Epithelial cancers such as oral cancer at early stages are rarely painful and hard to detect without invasive biopsy or radiation-based imaging like CT scan. The proposed handheld microscope, consisting of confocal MEMS imaging scanners with mechanically tunable resolution and field-of-view (FOV), allows doctors to closely exam epithelial layers at multiple depths without mechanical cutting, and identify early signs of cancers through morphologic changes and alternations in tissue architectures. The tunability of the resolution and FOV is achieved by active micro-mechanical adjustment on-chip. A handheld prototype will be built to test the diagnostic capabilities by utilizing ex vivo tissue samples and measuring tissue morphology and used in future clinical trials to identify pre-cancer in vivo relative to the gold standard of histo-pathology. The broader impact/commercial potential of this project is to enable a new class of clinical micro-imaging tools that can significantly improve early diagnosis of epithelial cancers leading towards individualized, minimally invasive treatment and improves long-term survival rates. Current diagnostic methods require recurring surgical biopsy of benign lesions and often detect malignant change too late for restorative treatment. The key innovation of this technology is that it translates confocal microscopy into in vivo application using miniature optics, optical fibers, tunable MEMS design and robust packaging technologies to provide clinicians and researchers a real-time 3D view of tissue cellular structure, without removal of tissue. This technology offers a potential breakthrough in non-invasive and radiation-free cancer diagnostics. The handheld scanner can not only be used to spot tumors at a very early stage and determine how far the cancer has progressed, it also can be used to monitor the tumor during treatment, and track the efficiency of therapy adopted, thus opening up a whole new opportunity to conquer cancers. The core technology builds on the strengths of the well-developed semiconductor industry and can potentially bring more intelligence to cancer imaging and lower healthcare cost.