The Facts*

Breast cancer is the most diagnosed cancer among women in the U.S. In 2024, there will be over 300,000 new cases of invasive breast cancer in women and an additional 56,500 cases of ductal carcinoma in situ (DCIS) in women. For women in the U.S., the lifetime risk of being diagnosed with invasive breast cancer has increased since 1975 from 1 in 11 to 1 in 8.  Progress in reducing breast cancer mortality has slowed in recent years, from 3% annually during the 1990s to 1% annually in 2021. While the breast cancer mortality rate has declined, the number of women who die each year is rising and will continue to rise as the aging population grows.
*National Breast Cancer Coalition 2024 Facts & Figures

The Risks**

Medical researchers have long recognized that over 95% of all breast cancer originates in the epithelial lining of the mammary ductal system. It is well established that in its early stages, most breast cancer develops very slowly and remains confined to the mammary ducts for up to 7-10 years. The analysis of individualized ductal systems provides the means to deliver a true personalized breast health assessment and discover the earliest signs of breast cancer risk.

About 85% of breast cancers occur in women who have no family history of breast cancer. These occur due to genetic mutations that happen as a result of the aging process and life in general, rather than inherited mutations.  Studies have shown that the risk for breast cancer is due to a combination of factors. Most breast cancers are found in women who are 50 years old or older. Some women will get breast cancer even without any other risk factors that they know of.  Having a risk factor does not mean one will get the disease, and not all risk factors have the same effect. Most women have some risk factors, but most women do not get breast cancer.  Each woman has a unique and personal risk profile, no two women have the same breast cancer risk profile.
**https://www.cdc.gov/cancer/breast/basic_info/risk_factors.htm        **https://www.breastcancer.org/facts-statistics

The Origins

Medical researchers have long recognized that over 95% of all breast cancer originates in the cellular lining of the mammary ductal system. It is well established that in its early stages, most breast cancer develops very slowly and remains confined to the mammary ducts for up to 7-10 years. The evaluation and exploration of the ductal systems provides the means to deliver a true personalized breast health assessment and discover the earliest signs of breast cancer.

An array of genetic, proteomic and cellular components is released into breast fluid by both normal and abnormal cells contained within the mammary ductal system. And these molecular by-products of both normal and/or abnormal cellular function are readily available for analysis. The analysis of individualized breast fluid provides the means to deliver personalized breast health care. Further evidence of the importance of focusing on the mammary ductal system rather than the breast is that non-invasive disease such as ductal carcinoma in situ (DCIS) is usually localized to a single ductal system. To this point, the intraductal approach suggests that breast cancer is a disease of the ductal system in which genetic factors predispose the duct to cancer.

Breast Cancer Progression

The Evolution

The urgent need for early detection of breast cancer is founded on the physiological condition that the molecular evolution of breast cancer cells (from precancerous, atypia, to malignant) is several years. Breast fluid offers a unique liquid biopsy that can be used to assess early cellular changes associated with breast cancer progression and provide a personalized breast health signature. This unmet clinical need for early detection, particularly in women already at high-risk and those with dense breast tissue, will require an evolutionary approach to the established imaging modalities - An Intraductal Approach.

The Solution

There is no universally accepted early detection technology for breast cancer. Mammography, Ultrasound, and MRI all have their advocates, and all have their skeptics. Medical researchers have long recognized that virtually all breast cancer originates in the cellular lining of the mammary ductal system. Knowledge of the anatomy, physiology and metabolism of the breast is essential in monitoring the status of breast health or dysfunction. Breast fluid also known as Nipple Aspirate Fluid (NAF), is the purest repository of those processes and is the gateway to personalized risk assessment, diagnosis, treatment, and surveillance of the breast in both health and disease.

Nipple aspirate fluid can be described as the Rosetta stone of normal or abnormal breast function. It provides analytic material to alert of dysfunction that is far beyond the standard means of clinical investigation used today. The changes that can be recognized may precede by years the development of a visible cancer on present state of the art imaging systems. A precision medicine assessment of breast fluid offers an early insight into a woman’s breast health changes.