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284 Alternative Biospecimen Stabilization and Storage Solutions
Number of anticipated awards: 2
(Fast-Track proposals will not be accepted. Phase II information is provided only for informational purposes to assist Phase I proposers with their long-term strategic planning.)
Budget (total costs): Phase I: $150,000;
Phase II: $1,000,000
(Note: It is strongly suggested that Proposals adhere to the above budget amounts. Proposals with budgets exceeding the above amounts may not be funded. Phase I project periods may last a maximum of 9 months.)
The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.
Summary:
Current methods for stabilizing tissue specimens for downstream molecular analyses, including freezing and embedding in paraffin, have not undergone significant improvements for many years, are not energy efficient, and require long-term investments in complex and expensive infrastructure. Biorepositories, especially those that store frozen specimens, require significant investments in personnel, space, and sophisticated monitoring and alarm systems to assure that optimal temperatures are maintained. Various dry storage techniques have been developed to provide an alternative to freezing and paraffin embedding, including blood and saliva spot cards. Such techniques have been widely used, for example in the CDC's neonatal screening program. However such methods have not been routinely developed for solid tissue specimens. New approaches are needed that are more universally suited to a variety of tissue types, and maintain the stability of all macromolecules. Such methods should not require hazardous chemicals or expensive equipment and should provide an alternative to the high energy costs required to maintain ultralow temperatures. A method suitable for room temperature storage is preferable. The stabilization process should be easily reversible in order for samples to be used quickly as needed. Finally, given the rapid turnover of RNA and other macromolecules, stabilization must occur almost immediately after removal from the patient.
Project Goals:
The focus of this solicitation is on the development of novel, innovative, or improved methodologies or reagents for the stabilization and/or storage of cancer tissue biospecimens and their resulting molecular analytes. As discussed in the above section, the NCI is interested in proposals that demonstrate how the product will overcome one of more of the limitations and disadvantages of current methods for stabilization and storage of biospecimens intended for use in molecular research, namely formalin-fixed paraffin embedded (FFPE) and frozen tissues. The project scope could include reagents and/or novel methodologies for biospecimen fixation, biospecimen storage, and short term post operative biospecimen stabilization for tissue evaluation and/or transport.
The short-term goal of this project is the identification and development of a technical strategy with the potential to serve as a useful alternative storage and/or stabilization reagent or method for use by the cancer research community.
The long-term goal of this project is to thoroughly test such a method or reagent for effectiveness as a storage and/or stabilization method for cancer biospecimens and/or analytes. Such testing will include evaluating the performance of alternatively fixed/stored biospecimens and analytes against case-matched biospecimens stabilized and stored in liquid nitrogen or FFPE. Performance evaluation of the product should focus on biospecimen molecular integrity and utility for molecular research platforms.
- Demonstrate proof of principle for the development of the reagent or method.
- Provide a description of the technical strategy for the stabilization or storage reagent highlighting the critical operating principles and the experimental design for testing if feasibility has been achieved.
- Demonstrate feasibility of use by providing a summary report of results from feasibility testing.
- Test the usefulness of the methods and/or reagent by comparing the outcome of appropriate molecular analysis (dependent on disease and specimen type) with that from matched frozen or FFPE biospecimens.
- Obtain input from potential customers in the research community in preparation for developing a comprehensive commercialization plan for the method or reagent.
Phase II activities and expected deliverables: Refine and analytically validate the reagent or method.
- Provide data comparing the fixation and/or stabilization method and/or reagent to previous widely used methods or reagents detailing performance and any improvements in 1) stabilization of proteins and nucleic acids, 2) quality of biospecimen or resulting analytes for molecular research, 3) general accessibility and ease of use, 4) cost effectiveness compared to FFPE or frozen storage, and 5) hazard level of the involved reagents.
- Demonstrate the use of the method or reagent by stabilizing or storing more than 20 disease matched biospecimens accompanied by matched samples stabilized by FFPE and by freezing, or more than 100 molecular analytes in comparison to all other currently available applicable stabilization and storage methods.
- Provide all comparison data to the NCI.
- Generate a scientific publication regarding assay or method performance targeted to the end user audience.
