DEVELOPMENT OF A SYSTEM (DEVICES AND PROTOCOLS) TO IMPROVE BIOSPECIMEN PRESERVATI


Year of Award:
2011
Award Type:
R21
Project Number:
CA155478
RFA Number:
RFA-CA-10-001
Technology Track:
Biospecimen Science Technologies
PI/Project Leader:
HRUDKA, BRIAN
Other PI or Project Leader:
N/A
Institution:
BIOSPECIMEN PROCUREMENT SOLUTIONS, INC.
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