Biomarkers play a central role in the detection, diagnosis, management and monitoring of patients with cancer. Factors such as analytical sensitivity and reproducibility are critical to the clinical utility of plasma based biomarkers in the setting of longitudinal surveillance and early detection of disease and or recurrence. Currently, the state of preservation of biospecimens is accomplished primarily using sub freezer techniques and it is cost prohibitive and certainly not practical in most scenarios. There is clearly a dearth of techniques that can preserve the biospecimens at room temperature for long periods of time. Therefore, there is a critical unmet clinical need for storing a plethora of biospecimens acquired routinely. Here, we propose to demonstrate stability and integrity of Pancreatic Cancer Specific biomarkers (CA-A19, miRNA21, and ctDNA) in buffers as well as plasma for extended periods of time at room temperature. There are several hurdles that must be overcome to realize the stabilization of biomarkers in plasma directly, due to its inherent complex nature. The proposed technology is based upon our innovation in developing CaRGOS: Capture and Release Gels for Optimized storage of Biospecimens. The technical impact of the proposed methodology is achievement of instantaneous one-step aqueous biospecimen preservative method for cancer research and clinical samples of interest. The proposed technology is extremely simple, user friendly, eliminates several complex processes, and more importantly requires no substantial equipment. The key scientific impact includes our fundamental insight into the interactions of the biomarkers and other proteins/solute with silica precursors. Based on this fundamental principle, the methodology can be easily expanded to other research areas including clinical samples, antigens, bio-pharmaceuticals, drugs, viruses and cell lines. If successful, the innovative proposed research will result in a paradigm shift in storage and preservation of Cancer Biospecimens in aqueous formulations that current techniques are unable to achieve.
