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

这个小企业创新研究第一阶段项目旨在开发和商业化一项技术，该技术可以通过简单的口腔拭子拭取脸颊上皮来筛查有肺癌风险的患者。在美国，肺癌是导致癌症死亡的首要原因。肺癌的致命原因在于它往往在晚期才被诊断出来，因为潜在的可治愈阶段通常在临床上是沉默的。肺癌的存活率很大程度上取决于它被诊断的阶段。然而，从敏感性或疗效/成本效益的角度来看，现有的筛查方法都是不够的。因此，找到一种筛查方法来识别有风险的患者将是至关重要的。在第一阶段，将开发一种高通量部分波光谱（HT-PWS）显微镜，该显微镜可以量化细胞纳米级组织的统计特性，并识别与肺癌相关的颊上皮细胞的早期癌变。这项检测将是简单、廉价、微创和高度准确的，并将基于经过充分验证的野外致癌生物学现象。该项目的更广泛的影响/商业化潜力是，基于部分波光谱（PWS）显微镜的检测将显著提高肺癌筛查的准确性，并允许在早期可治愈阶段诊断疾病。这项技术的愿景是成为肺癌的主要一线筛查方法，这是一个价值50亿美元的市场，在美国估计有4600万吸烟者。基于PWS显微镜的筛查技术将由初级保健医生或牙医对吸烟者进行，作为年度检查的一部分（如年度巴氏涂片检查）。如果结果是阴性（没有风险），那么患者将在下次年度体检时重新进行检测。然而，如果结果是阳性的，那么病人将被送去做其他更昂贵/侵入性的检查，如计算机断层扫描（CT）和支气管镜检查。因为与今天相比，更多的高危患者可能会接受肺癌筛查，这将对美国的医疗保健产生重大影响，既降低了医疗保健成本，又挽救了宝贵的生命。

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.