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