Normal and disease tissue biospecimens likely contain all the molecular information required to define disease prognosis and guide treatment. This has been reduced to practice in the diagnosis and treatment of breast cancer, evidenced by the commercial success of the Mamaprint(R) genomic test (Agendia, Inc;based on estrogen and progesterone sensitivity biomarkers). However, it is recognized that power and utility of today's exquisitely sensitive analytical tools is limited by the quality of the biomarkers measured. Biomarker pre- analytical variability resulting from improper and inconsistent biospecimen acquisition, fixation and shipment can affect the results of molecular analysis and therefore cancer research and therapeutic decisions. Recognizing this, Core Prognostics, Inc. (CPX) developed a unique system (device and protocols) to greatly enhance the convenience, success rate, and reproducibility of biospecimen acquisition and shipping. This passively-cooled system is laboratory-validated and has a proven track record of performance in biomarker- based multi-center clinical trials including three sponsored by NCI cooperative groups. However, as experience has been gained with the system, opportunities for improvement have been defined. Specifically, the experience of CPX shows that a passively-cooled system is inherently unable to guarantee tissue sample quality when simultaneously shipping multiple temperature specimens under different environmental conditions and when operated by technicians with varying experience levels.
The specific aim of this project is to create a reusable actively-cooled system to conveniently and reproducibly refrigerate multiple tissue samples to <-700C, 40C and 150C and precisely maintain temperatures during shipment. The research strategy is to expand existing CPX technology partnerships to access the expertise required to achieve the considerable thermodynamic, refrigeration, design, fabrication, hardware and software innovation and laboratory testing necessary to achieve the goals of this proposal. "Off- the-shelf" components will be utilized to the greatest extent possible, to take advantage of existing technology, reduce project time and expense as well as the anticipated cost of the final product. The practical benefits of a successful project to improve biospecimen cryopreservation and shipping from patient to analytical laboratory will be to: 1.) substantially increase the reliability and reproducibility of biospecimen preservation and shipping;2.) create broader access to the collection of a wide range of tissue types;3.) improve the convenience and flexibility of tissue acquisition;and, 4.) reduce the cost and environmental impact over current single-use solutions. In the long-term, these benefits support the mission of NCI OBBR: "to guide, coordinate, and develop the Institute's biospecimen resources and capabilities and ensure that human biospecimens available for cancer research are of the highest quality"1 1. National Cancer Institute (NCI), Office of Biorepositories and Biospecimen Research (OBBR) website.
Key to cancer research today, and widespread implementation of personalized medical technologies in the future, is the need for significantly increased consistency and accessibility of biospecimen preservation and shipping from patient to analytical laboratory. Improvement of this important and under-investigated patient-to- platform link, for the benefit of cancer research, prevention and treatment efforts, is the subject of this proposal.