Origins of Breast Cancer

The Intraductal Evolution

Medical researchers have long recognized that nearly all breast cancer originates in the epithelial lining of the mammary ductal system and its adjacent microenvironment. It is well established that the earliest stages of breast cancer evolve slowly. Indeed, most types of breast cancer develop very slowly and initially remain confined to the mammary ductal wall for up to 7-10 years. More importantly, this ‘silent’ stage of early cancer development produces identifiable metabolic products that are contained within ductal fluid. This array of genetic, proteomic and cellular components is released into ductal fluid by both normal and abnormal cells contained within the mammary ductal system. And it is these molecular biproducts of both normal and/or abnormal cellular function that are readily available for analysis. It is this analysis of individualized ductal fluid that provides the means to deliver personalized breast health care.

Nipple Aspirate Fluid

The Intraductal Opportunity

The breast contains distinct ductal systems that drain geographically distinct areas of the breast, the lobes. The ductal system carries mother’s milk to the surface of the breast after childbirth. In the non-pregnant state, the ductal system contains the products of ductal cells and that of its supporting peri ductal cellular tissue. Medical researchers have long recognized that virtually all breast disease originates in the epithelial lining of the mammary ductal system. Knowledge of the anatomy and physiology of ductal tissue and its supporting microenvironment is essential to monitor the health or dysfunction of the breast. Knowledge of the anatomy, physiology and metabolism of the breast is essential in monitoring the status of breast health or dysfunction. Nipple Aspirate Fluid (also known as 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.

The expression of NAF on the surface of the breast marks the external opening to the duct under examination. It also provides a sample for analysis of content. Breast nipple aspirate fluid can be described as the Rosetta stone of normal or abnormal breast function. It provides analytic material to alert the examiner 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. Genetic products and metabolic products of cellular growth are now and will continue to be studied by analyzing the content of breast ductal fluid. NAF content does provide evidence of abnormal function far earlier then screening techniques utilized today. NAF can identify individuals that are presently at risk or are already the unwitting victim of a nascent breast cancer. Recognition of a nascent breast cancer will provide valuable lead time for early diagnosis, intervention and treatment. Identification of the ductal system also enables the performance of breast endoscopy to visualize the ductal system. Identification of a visualized abnormality will be followed by sampling and histologic confirmation of dysfunction. Once the ductal orifice and site of abnormality is known and diagnosis confirmed, appropriate treatment can be administered by endoscopic assistance adjunctive to standard surgical means or non-surgically via endoscopic delivery of preventive or ablative treatment to diagnosed abnormalities.

Breast Endoscopy/Ductoscopy

The Promise of Breast Endoscopy/Ductoscopy

Malignant changes of the mammary duct epithelium (lining) of the breast (DCIS, LCIS, ADH) inevitably precede the development of invasive breast cancer. Although these histologically recognized changes are usually present for some years, they are only occasionally detectable on mammography. As a result, 80% of women are only diagnosed after an invasive cancer has arisen and the opportunity of treatment, when the malignancy is confined to the breast, is missed. The more effective the detection of DCIS and ADH will offers a way of preventing many cases of invasive breast cancer and is the aim of CYductDX.

The small size of the mammary ducts poses significant technical limitations. The great promise of an intraductal approach requires technology that provides (direct) endoscopic visualization of the mammary duct system capable of yielding images of high quality and detail, sufficient size, enhanced resolution and optical magnification for critical clinical decision-making. With the CYductDX MammoView System, the Company has overcome the technical obstacles and is literally changing the clinical picture. The result is a technology capable of accessing the mammary ducts for screening, detection, diagnosis and treatment intervention of DCIS, LCIS, ADH and all with large, clear, sharp real-time video images. In the TIME Magazine issue entitled; “The New Thinking on Breast Cancer” – breast endoscopy was featured as one of the leading technologies to impact breast cancer detection and treatment in the future.

That future is now. Breast endoscopy has the distinct advantage of being the only available procedure that while remaining minimally invasive, allows direct visual examination of breast duct epithelium and allows for cytological and histological diagnosis. The procedure has been shown for over 20 years, to be entirely safe and extremely well tolerated by patients when used in a clinical setting. CYductDX currently offers a line of breast endoscopy products (MammoView), which are utilized at many of the leading centers for breast cancer research and treatment in the Unites States. Leading physicians believe that the CYductDX products for mammary ductoscopy could be used as a visual guide to pinpoint suspicious premalignant and cancerous lesions for surgical tissue sampling or removal. Today, these products are being used in this manner, where surgeons are reporting favorable success.