Detection of saliva proteins modulated secondary to ductal carcinoma in situ of the breast

Abstract

A method of differentiating among the presence of ductal carcinoma in situ in the breast, benign fibroadenoma of the breast, and non-cancerous breast tissue in a subject is disclosed. The method comprises: measuring the concentration of at least one protein biomarker selected from a group of forty-nine differentially expressed proteins in the saliva of persons with DCIS, or benign fibroadenoma, or in persons who are cancer-free. The resulting test data is compared to a reference panel. From the comparison the presence in the subject of either ductal carcinoma in situ of the breast, or benign fibroadenoma of the breast is determined.

Description

BACKGROUND[0001]1. Technical Field[0002]The invention generally relates to methods and compositions for diagnosing breast cancer, and, more particularly, to such methods and compositions which use the differential expression of protein biomarkers in the saliva of an individual to differentiate among ductal carcinoma in situ of the breast, benign fibroadenoma and non-cancerous tissue in that individual.[0003]2. Description of Related Art[0004]Conventional physical examination and mammography are useful screening procedures for the early detection of breast cancer. However, they can produce a substantial percentage of false positive and false negative results especially in women with dense parenchymal breast tissue. Consequently, screening results in a number of negative biopsy results yielding a high percentage of false positives. There is also a demonstrated lack of sensitivity in detecting cancerous lesions in younger women yielding a significant percentage of false negatives. Alth...

AI Technical Summary

Benefits of technology

"The patent describes a method for diagnosing breast tumors by measuring the concentration of certain proteins in saliva samples. These proteins are known to be differentially expressed in breast tumors and tumor-free breast tissue. The method involves comparing the concentration data of the proteins in the saliva sample to a reference panel, which includes the mean concentration values of each protein in saliva samples from a group of individuals without breast cancer or benign breast disease. By measuring the concentration of these proteins in a saliva sample from a test subject, a diagnosis of likelihood of breast cancer or benign breast disease can be determined. The method can be used in a diagnostic test for breast cancer that is simple, accurate, and non-invasive."

Problems solved by technology

However, they can produce a substantial percentage of false positive and false negative results especially in women with dense parenchymal breast tissue.

Consequently, screening results in a number of negative biopsy results yielding a high percentage of false positives.

There is also a demonstrated lack of sensitivity in detecting cancerous lesions in younger women yielding a significant percentage of false negatives.

There is a paucity of information regarding the salivary proteome and its constituents in the presence of disease such as carcinoma.

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