OTHER FUNCTIONS CIRCULATING TUMOR CELL ENUMERATION PRODUCT

本SBIR II期对照申请是应成功完成题为“循环肿瘤细胞计数产品”的I期后发出的邀请而提交的。I期将证明该产品作为疑似原发性肺癌组织确认的替代品的临床效用。第一阶段合同是根据2009年招标主题272授予的，旨在开发一种临床上有用的方法，用于识别和计数循环肿瘤细胞，适用于早期商业化和实施，作为护理点解决方案。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施。使检测尽可能接近患者的最终目标是检测开发的关键驱动因素。正是为了实现这一目标，CTC计数方法被限制为保持下游表征能力的方法。在第一阶段合同期间，我们已经开发并在技术和临床上验证了已鉴定CTC的分子表征，可在完成初步鉴定和计数后应用。这为初始产品作为液体活检提供了坚实的产品基础，该液体活检可在大多数患者中识别有意义数量的疾病来源细胞。第二阶段将侧重于两个适用和预期的活动，第一个是开发GLP验证的检测方法，第二个是检测足够数量的患者 样本以证明临床效用。

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.