Predictive biomarkers for breast cancer
AssigneeNuclea Biotechnologies, Inc.
InventorPatrick J. Muraca
Life of this patent
Estimating the term…
Abstract
The invention relates to compositions and methods for detecting, screening, diagnosing or determining the progression of, regression of and/or survival from a proliferative disease or condition, specifically breast cancer. The invention also provides new assays and kits for the staging or stratifying breast cancer patients or patients suspected of having breast cancer.
Claims20
A method of predicting a clinical outcome of a patient diagnosed with breast cancer, the method comprising
- a. obtaining a tissue sample from the patient by excision, aspiration or biopsy,
- b. assaying the sample by one or more colorimetric methods to determine the nuclear stain intensity and stain positivity of fatty acid synthase, and
- c. classifying as a good clinical outcome any assay results where stain intensity and stain positivity are individually at least 2.00.
A method for predicting the of likelihood of a metastatic event occurring within five years in a lymph node negative patient diagnosed with breast cancer independent of age, Her2/neu status or estrogen receptor status comprising;
- a. obtaining a breast tissue sample from the patient by excision, aspiration or biopsy,
- b. assaying the sample to determine the nuclear stain positivity boundary pair scores of fatty acid synthase,
- c. classifying the results of step b as likely to predict the occurrence of a metastatic event in the patient when the boundary pair scores are individually less than 2.00.
A method for predicting the five year survival rate of a female patient diagnosed with breast cancer independent of cancer stage, comprising;
- a. obtaining a breast biopsy at least 2 cm in diameter;
- b. assaying the breast biopsy and resected margins of the breast biopsy of (a) for one or more cancer markers;
- c. obtaining a nipple aspirate sample from the patient,
- d. assaying the nipple aspirate to determine the nuclear stain scores of fatty acid synthase (FAS);
- and
- e. classifying the results of step (d) as predictive of less than a five year survival rate for the patient when the FAS score is at least 2 and the resected margins of the breast biopsy of (b) are positive for one or more cancer markers.
Dependencies are inferred from the claim text.