Absorbent paper and use thereof for breast cancer detection

Abstract

Biological samples of mammary fluid or components thereof are obtained using a breast pump device coupled with an absorbent paper or membrane, optionally facilitated by administering oxytocin to the subject. The breast pump device stimulates expression of mammary fluid and provides for collection of diagnostic samples on the absorbent paper or membrane to evaluate breast disease, including cancer. The biological sample may include fluid containing one or more of cells or cellular components, proteins, glycoproteins, peptides, nucleotides or other desired constituents comprising a breast disease marker. Absorbent paper or membrane, and methods relating to the paper or membrane, and a breast pump device are also provided.

Description

CROSS-REFERENCE[0001]This application claims the benefit of U.S. Provisional Application No. 61 / 550,855, filed Oct. 24, 2011, which application is incorporated herein by reference.BACKGROUND OF THE INVENTION[0002]Breast cancer is by far the most common form of cancer in women, and it is the second leading cause of cancer death in humans. Despite advances in diagnosing and treating breast cancer, the prevalence of this disease has been steadily rising at a rate of about 1% per year since 1940. Today, the likelihood that a women living in North America will develop breast cancer during her lifetime is one in eight.[0003]The current widespread use of mammography has resulted in improved detection of breast cancer. Nonetheless, the death rate due to breast cancer has remained unchanged at about 27 deaths per 100,000 women. All too often, breast cancer is discovered at a stage that is too far advanced, when therapeutic options and survival rates are severely limited.SUMMARY OF THE INVENT...

AI Technical Summary

Benefits of technology

The present invention introduces a new absorbent paper or membrane that reduces the number of cuts during sample collection and allows for low sample volume collection from women who were previously considered non-secretors. This invention also increases the sensitivity of protein detection, allowing for the early diagnosis of breast cancer. The new methods are less painful and discomforting to patients, as the absorbent paper or membrane does not cut tissue to the extent that current filter paper does. The invention is useful for both non-secretors and secretors, and can detect protein in nipple aspirate fluid at a concentration of as low as about 70 picograms.

Problems solved by technology

The clinical utility of nipple aspirate fluid for helping in breast health management has been hampered over the last 50 years by the current clinical methodology of collecting and measuring the presence of fluid.

In fact, using current technology, up to 50% of all women are non-secretors, that is, they are judged to not produce nipple aspirate fluid (NAF); this, in turn, means that these women cannot be tested for diagnosis of early stage breast cancer using non-invasive procedures using current technology.

Additionally, paper used to collect fluid from non-secreting and secreting women using current technology results in a significant number of paper cuts to the nipple tissue, rendering sample collection painful for women undergoing testing.

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