Find Funding

Contract Topics

257 Biopsy Instruments and Devices that Preserve Molecular Profiles in Tumors

Number of anticipated awards: 2

(Fast-Track proposals will be accepted.)

Budget (total costs): Phase I: $250,000;
Phase II: $2,000,000

(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:
Molecular medicine holds much promise for advancing cancer diagnosis and treatment, if biomarkers, molecular targets, and drug effects on these targets can be accurately assessed in tumor nodules in the viscera. The amount and function of molecular drug targets within signal transduction pathways are often regulated by rapid enzymatic reactions in response to physiological stimuli. Biopsies play a central role in assessing biomarkers and molecular targets in solid tumors, but conventional practices and medications used by surgeons and interventional radiologists necessarily perturb the tumor environment and thereby induce extraneous and confounding molecular responses to tissue trauma, vascular changes, hypoxia, anesthetics, etc. Expeditious processing of the biopsy specimen using snap freezing or rapid fixation are ineffective for preventing many rapid enzymatic modifications, because time frames of biopsy procedures are much longer than that of the enzymatic reactions. Thus, there is a need to develop clinical devices, instruments, and approaches suitable for clinical practice that stabilize molecular profiles in visceral tumor lesions during the procedure, and prevent molecular response to the procedure. The diagnostics market includes devices for needle cryobiopsy of breast lesions that freeze the tissue in situ before sampling, but the needle size is too large for percutaneous image-guided biopsy of visceral sites. Although unlikely to improve routine diagnostic biopsies, innovative approaches for tumor biopsy that preserve the molecular profile will create an entirely new diagnostic area and market in molecular therapeutics, which will not only facilitate pharmacodynamic assessment of targeted therapeutics but also enable individualized molecular therapy of solid tumors based on accurate information about signal transduction pathways, molecular drug targets and biomarkers.

Project Goals:
The short-term goal of the project is the identification of technical strategies with potential for stabilizing the molecular profile of cancerous lesions in visceral tissue sites during clinical biopsy procedures. The long-term goals of the project are the design and development of operational prototype instruments/devices required to practice the innovative biopsy approach; the demonstration of the operational success of the innovative approach when applied to visceral lesions of solid tumors in model systems; and the evaluation of the potential superiority of the innovative biopsy approach over conventional surgical and radiological procedures for assessing highly dynamic molecular profiles that are associated with a high degree of instability during conventional biopsy procedures. The project scope includes advancements in biopsy technologies and approaches from any medical discipline performing biopsy procedures (surgery, radiology, dermatology, etc.) that improve the fidelity of molecular assessment of visceral tumor lesions. Reaching these goals on the basis of experimental evidence will mark a major advance in the ability to accurately assess the molecular profile of solid tumor lesions of the viscera and the functional status of their molecular targets during early clinical trials of experimental therapeutics. If successful, this project will improve the accuracy of biomarker assessment for diagnosis and prognosis and the information available about the pharmacodynamics and molecular efficacy of targeted drug therapy.