Molecular Diagnostics for Breast Cancer Precursors

Background:
The National Cancer Institute, Genetics Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize a method of profiling ductal carcinoma of the breast.

The implementation of mammographic screening for breast cancer has led to the frequent identification of early tumors that are confined to the ductal system of the breast. These tumors are termed ductal carcinoma in situ (DCIS). Many of these tumors are low grade and can be treated with lumpectomy or other simple procedures. However, some will become invasive or metastatic cancers. Currently, there is no predictive system to determine which category a patient falls into.

Technology:
This technology is a molecular profiling for ductal carcinoma in situ (DCIS) in breast cancer patients that utilizes both gene expression and genomic change. The molecular profiles identify early stage patients at risk of disease progression. These observations suggest that an accurate clinical assay for DCIS, able to diagnose patients according to their risk of tumor progression, can be developed. This diagnostic can assist physicians in making personalized therapy decisions for DCIS patients. Tissue samples collected using laser capture micro-dissection from breast cancer patients have already been used to validate and authenticate the relevance of this technology.

Further R&D Needed:
Develop a streamlined method for applying the molecular signature identified to clinical samples without microdissection. This method could be based on quantitative PCR, microarrays, and/or immunostaining.

R&D Status:
A larger clinical study is currently being planned.

IP Status:
U.S. Provisional Application No. 60/936,526 filed 20 Jun 2007

Value Proposition:

• Potential to develop an accurate diagnostic test for DCIS that classifies patients according to their risk of tumor progression.
• Ability to assist physicians in making personalized therapy decisions for DCIS patients.

Contact Information:
John D. Hewes, Ph.D.
NCI Technology Transfer Center
Phone: 301-435-3121
E-mail: Hewesj@mail.nih.gov

Reference:  #656 PM

Posted 07/16/2008