OTHER FUNCTIONS CIRCULATING TUMOR CELL ENUMERATION PRODUCT

该SBIR II期合同申请是在成功完成名为“循环肿瘤细胞枚举产品”的I期后延长的邀请下提交的。I期临床试验将展示该产品作为疑似原发性肺癌组织确认替代物的临床效用。该I期合同是根据2009年招标主题272授予的，旨在开发一种临床有用的方法，用于识别和枚举循环肿瘤细胞，适合早期商业化和作为护理点解决方案的实施。在这种情况下，护理点被定义为一种易于部署的技术，具有低成本的消耗品和设备，可扩展到最终的护理点实现。使检测尽可能接近患者的最终目标是检测发展的关键驱动因素。正是为了实现这一目标，CTC枚举的方法被限制为一种保持下游表征能力的方法。在第一阶段合同期内，我们已经开发并在技术和临床上验证了已鉴定的ctc的分子表征，可在初步鉴定和枚举完成后应用。这为作为液体活检的初始产品提供了坚实的产品基础，该产品可识别大多数患者中有意义数量的疾病来源细胞。II期将侧重于两项适用和预期的活动，第一个是开发GLP验证分析，第二个是对足够数量的患者进行测试

This SBIR Phase II controct application is submitted in response to the invitation that was extended after successful completion of the phase I entitled 'Circulating Tumor Cell Enumeration Product'. The Phase /I will demonstrate dinical utility of the product as a surrogate for tissue confirmation of suspected primary lung cancer. The phase I contract was awarded in response to the 2009 solicitation topic 272 and is aimed at developing a clinically useful method for the identification and enumeration of Circulating tumor cells suitable for early stage commercialization and Implementation as a point of care solution. Point of Care in this context is defined as an easily deployable technology with low cost of consumables and devices that is scalable to an eventual point of care implementation. The ultimate goal of getting the test as close as possible to the patient is a key driver in the assay development. It was in pursuit of this goal that the methodology for CTC enumeration was restricted to a method that maintained the ability for downstream characterization. During the phase I contract period, we have developed and both technically and dinically validated molecular characterization of identified CTCs, which can be applied after the initial identification and enumeration is completed. This provides a solid product foundation of the initial product as a fluid biopsy that identifies meaningful numbers of disease derived cells in the majority of patients. The phase II will focus on the two applicable and expected activities, the first being the development of a GLP validated assay and second being the testing of sufficient number of patient samples to demonstrate clinical utility.