Develop a molecular diagnostic (MDx) test, implemented on a gene expression based analysis platform. The test will be performed on surgical or biopsy samples from breast cancer patients considered for treatment with radiotherapy and provide new predictive information on response to radiotherapy that is independent of existing clinical decision parameters.
The new test has potential to become “first in class” and lead to better informed treatment decisions, improved clinical outcome as well as reduced toxicity and cost from unnecessary RT.
Predictive test developed from analysis of a subset of 200 patients from the (Danish) DBCCG82bc cohort, in which patients was randomized to +/- RT treatment after mastectomy.
The test uses a Radiotherapy Response Prediction (RRP) Index generated from a weighted normalized expression of informative genes that indicates significant benefits of RT for patents with a high RRP index and no significant benefits for patients with a low RRP index:
A patent application (WO 2013/132354A2) protecting the invention is currently pending in multiple jurisdictions (US, EP, JP, IN, AU).