A Molecular Grading System for Ductal Carcinoma In Situ (DCIS) of the Breast: A New Molecular Diagnostics to Determine Disease Stages of DCIS
Description of Invention:
The technology describes the comprehensive profiling of Ductal Carcinoma in situ (DCIS) in breast cancer patients. The inventors have developed a molecular grading system for DCIS utilizing both gene expression profiling and genomic change profiling. The inventors have identified molecular profiles that identify early stage patients at risk of disease progression requiring more aggressive therapy. These observations suggest that a clinical assay could be developed for the grading of DCIS. Furthermore, the invention demonstrates that the profiles correlate with the molecular grade and with cell proliferation, suggesting that a clinical assay using routine methods, based on the nuclear grade and staining for Ki67 as a measure of proliferation, could also potentially be developed.
Advantages and Applications:
The technology has the potential being developed into an accurate diagnostic test for DCIS patients according to their risk of tumor progression.
The diagnostic profiling can assist physicians in making clinically informed and personalized therapy decisions for DCIS patients.
In the studies, tissue samples collected via laser capture micro-dissection from in situ breast cancer patients were used, which validate and authenticate the relevance of the study.
Development Status:
Larger clinical study is currently being planned.
Patent Status:
DHHS Reference No. E-192-2007/0 --
U.S. Provisional Application No. 60/936,526 filed 20 Jun 2007
Licensing Status: Available for exclusive and non-exclusive licensing.
Collaborative Research Opportunity:
The National Cancer Institue, Genetics Branch, is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize molecular grading of DCIS. Please contact John D. Hewes, Ph.D. at 301-435-3121 or hewesj@mail.nih.gov for more information.
Portfolios: Cancer
Cancer -Diagnostics-In Vitro-DNA Based Cancer -Diagnostics
For Additional Information Please Contact: Mojdeh Bahar J.D.
NIH Office of Technology Transfer
6011 Executive Blvd, Suite 325
Rockville, MD 20852-3804
Phone: (301)435-2950
Email: baharm@mail.nih.gov
Fax: (301) 402-0220
