SBIR Phase I: Partial Wave Spectroscopic (PWS) Microscopy: an Early Screening for Lung Cancer

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This Small Business Innovation Research Phase I project aims to develop and commercialize a technology that can screen patients who are at risk for lung cancer by means of a simple buccal swab of the cheek epithelium. Lung cancer is the leading cause of cancer deaths in the U.S. The reason for the lethality of lung cancer relates to its tendency to be diagnosed at a late stage, given that the potentially curable stages of disease are often clinically silent. Survival rates for lung cancer depend dramatically on the stage at which it is diagnosed. However, existing screening approaches have been inadequate from either a sensitivity or efficacy/cost-effectiveness perspective. Thus, finding a screening method to identify patients at risk would be critical. In Phase I, a high-throughput partial wave spectroscopic (HT-PWS) microscope that can quantify the statistical properties of cellular nanoscale organization and identify early cancerous changes in buccal epithelial cells, which are associated with lung cancer, will be developed. This test will be simple, inexpensive, minimally invasive, and highly accurate and will be based on the well-validated biological phenomena of field carcinogenesis. The broader impact/commercialization potential of this project is that the partial wave spectroscopic (PWS) microscope-based testing would significantly improve the accuracy of lung cancer screening and allow diagnosis of the disease at an early, curable stage. The vision is for this technology to become a primary font-line screening method for lung cancer which is a $5B market, with an estimated 46M smokers in the United States. The PWS microscopy-based screening technique would be performed on smokers by a primary care physician or dentist as part of an annual exam (like an annual Pap smear test). If the result is negative (not at risk), then the patient would be retested at their next annual physical. However, if the result is positive then the patient will be sent for other more expensive/invasive tests such as Computed tomography (CT) and bronchoscopy. Because significantly more at-risk patients would likely be screened for lung cancer than today, this would have a major impact on healthcare in the United States by both reducing the cost of healthcare and by saving valuable human life.