OTHER FUNCTIONS CIRCULATING TUMOR CELL ENUMERATION PRODUCT

本SBIR第二阶段控制申请是应在成功完成第一阶段“循环肿瘤细胞计数产品”后发出的邀请而提交的。该阶段/I将展示该产品作为疑似原发肺癌组织确认的替代产品的临床用途。第一阶段合同是根据2009年的征集主题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中的肿瘤细胞，适合早期商业化并作为护理点解决方案实施。在这种情况下，关注点被定义为一种易于部署的技术，具有低耗材和低设备成本，并且可扩展到最终的关注点实施。让测试尽可能接近患者的最终目标是测试开发的关键驱动因素。正是为了实现这一目标，四氯化碳的列举方法被限制在一种保持下游表征能力的方法上。在第一阶段合同期间，我们开发了已识别的CTCs的分子表征，并进行了技术和临床验证，可在初步鉴定和计数完成后应用。这为最初的产品提供了坚实的产品基础，作为液体活检，在大多数患者中识别出有意义数量的疾病来源细胞。第二阶段将集中于两个可适用和预期的活动，第一个是开发GLP验证的分析，第二个是对足够数量的患者进行测试 样本，以证明临床实用。

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.