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283 Development of a Molecular Diagnostic Assay to Detect Basal-like Breast Cancer

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:
Breast cancer is a heterogeneous disease with a number of distinct biological entities that are associated with specific morphological/immune-histochemical features and clinical behavior. Basal-like breast cancer is one of the five intrinsic subtypes, which was classified by gene expression profiling in breast cancer. The four other subtypes include luminal A, luminal B, human epidermal growth factor receptor-2 (HER2) over expressing, and normal-like. 15-20% of breast cancer patients have basal-like subtype, which is the most aggressive subtype in breast cancer. It is associated with high grade, poor prognosis, and younger patient age. Population-based study has shown that this subtype is more prevalent in premenopausal African American women, which may contribute to the poor outcomes seen among these patients. Currently there is no effective assay product with low cost to detect basal-like subtype in the market. The purpose of this initiative is to provide support for the development of a molecular diagnostic assay to detect basal-like breast cancer. The selected offerors will develop an assay for detection of basal-like subtype at cell, protein, or DNA level, so that basal-like breast cancer can be identified specifically. The final assay should enable test to be completed within one day at a low cost. In Phase I, the development of molecular diagnostic assay should focus on proof of concept. In Phase II, the assay developed in Phase I will be validated under a plan developed with the NCI project officer.

Project Goals:
The goal of the project is to develop a molecular diagnostic assay to detect basal-like breast cancer with sensitivity and specificity that is able to distinguish basal-like breast cancer from other subtypes in both human cells and tissues. The assay can be used for early detection of basal-like breast cancer, or be used as post-treatment monitoring to detect recurrence of the cancer. The assay may also be used to provide a better mechanistic understanding of basal-like tumor development, so the knowledge can help develop preventive, diagnostic, or therapeutic agents that target specifically against basal-like subtype and further improve patient outcome. The assay development should be platform driven, meaning that the procedure for the assay development should be easily applied for a new assay development for the detection of other cancer subtypes in breast cancer or other cancer types such as prostate or colon cancers.