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.
