The Current Status of Breast Care

Edmond Rambod, PhD, EMBA
Chairman & Chief Executive Officer

September 2016

Breast cancer has become a worldwide epidemic and has reached alarming rates. Prevalence rates of this disease, based on current statistical reports, are extremely disturbing and prove, irrefutably, that society’s efforts thus far in addressing the issue have failed to produce the desired results. Neither has a universal cure been found, nor has an effective procedure been developed to prevent, or even confine the disease:

  • US Mortality Rate: ~ 50,000/year (6/hour)
  • Worldwide Mortality Rate: ~ 600,000/year (1/minute)
  • US Morbidity Rate: ~ 250,000/year (30/hour)
  • Worldwide Morbidity Rate: ~ 1,600,000/year (3/minute)

Quantason has selected to follow a fundamentally different approach in combating this disease. Instead of passively awaiting the occurrence of the disease and then seeking treatments, Quantason has embarked on a proactive market-driven innovation process that aims at preventing the inception of breast cancer. This disruptive approach requires knowledge of the disease itself, of screening and diagnostic technologies currently available and of policies adopted by different states and countries. It further requires the ability to think creatively and develop an advanced proactive and novel screening modality that allows for the earlier, better, easier, radiation-free, patient-friendly and cost-effective detection and mapping of the anatomical precursor of breast cancer (i.e., DCIS) with clearer and more readily interpretable results. This groundbreaking modality will be suitable for all adult women irrespective of age, ethnicity, skin color, breast density or size, implants, pregnancy and lactation history, or planned radiation therapy. Timely detection and proactive removal of the clinically known precursor will physically alter the environment in which it was found, consequently eliminating the conditions necessary for the inception of cancer.

While x-ray mammography is the standard of care in breast screening and diagnosis, it has been widely controversial and subject to severe scrutiny. Other modalities seem to follow suit in their prohibitively high cost, administration of harmful agents or lack of availability, insufficient sensitivity to the precursor of cancer for effective early detection, or inadequate specificity in differentiating cancerous tumors from benign masses. The outcome of the current state of affairs has been negatively affecting society in general and the global women population in particular.

X-Ray Mammography
It is acknowledged that mammography's sensitivity diminishes in proportion to breast fibroglandular density, and that when women's breasts are heterogeneously dense (ACR BI-RADS density 3) or extremely dense (BI-RADS category 4), that masses may be less or inconspicuous. The reason for this is a contrast limitation of a white mass situated within white fibroglandular tissue. When the background tissue is dark gray, it is easy to perceive a lighter colored mass and to analyze its shape and margins. An indication for ultrasound is confirmation and characterization of a palpable or suspected mammographic abnormality. There is little controversy regarding this recommendation, and it is and has been for many years listed among the indications for breast ultrasound (ACR, Reston, VA). In the most recently approved version of the Guideline for the Performance of the Breast Ultrasound Examination (May, 2011), screening of high risk women and extent of disease evaluations in newly diagnosed or suspected breast cancer patients has been moved from "an area of research" to an indication.

Role of the FDA Guidelines
It is not the FDA that specifies policies but rather approves or qualifies use of equipment and devices for efficacy and safety in exams and procedures. Recommendations for screening come from various organization and advisory agencies. The current recommendation for breast cancer mammography screening to start at 40 and annually thereafter was voiced by the USPSTF (United States Preventive Services Task Force) in 2002. These guidelines were upheld by the Department of Health and Human Services over the more recent USPSTF recommendations to begin screening for average risk women at 45 or 50 with screening mammography to continue biennially. X-ray mammography is the only examination established through randomized controlled trials to reduce breast cancer mortality.

Dense Breasts Care
No examination is perfect, and mammography's limitations for depicting masses in dense breast tissue are known. In the last several years, breast density itself has been established as a risk factor, breast density law has been adopted by 27 states and being legislated in eight more states and much attention has been given to the supplementation of mammography with additional studies that might find cancers occult on mammography. Most sensitive of these imaging examinations is contrast-enhanced breast MRI, costly and requiring intravenous contrast material, and MRI is recommended by the American Cancer Society and other organizations for the highest risk women, those with genetic abnormalities such as BR-CA 1 or 2 or prior treatment with radiation for mediastinal lymphoma. Screening MRI in addition to screening mammography is being reimbursed for these patients. For women of intermediate risk, availability and reimbursement for MRI is problematic, and attention has turned to ultrasound, of far less cost, with no ionizing radiation and without need for contrast material.

New Innovations in Breast Care
Much innovative design has focused on creation of automated scanners, both the prone and supine varieties, systems which depict the entire breast rather than the small windows into tissue that current high resolution handheld ultrasound provides. In the United States, different practice patterns are evolving compared with common practice in Europe and Asia, where breast ultrasound is ordinarily performed by physicians, who are detecting, characterizing, and assessing in real time. In the U.S., volume demands make comprehensive breast sonography by the breast imager a task that cannot be satisfactorily completed, and sonographers are doing much of the basic scanning. Automation would help in that a 3-D volumetric image acquisition done by a sonographer or nurse is accomplished within ten to fifteen minutes, and the interpretation made on the workstation.

Role of IDUS™ in Breast Care
Why can't ultrasound substitute for mammography rather than supplement it? Ultrasound's main contribution is finding masses, ordinarily invasive if these masses are malignant (ACRIN 6666 first year results, Berg, et al, JAMA, May 2008). Microcalcifications, the other important sign of breast cancer, may be visible and identifiable on ultrasound, but it is difficult to track the patterns, which on mammography, even within dense tissue, may suggest ductal carcinoma in situ (DCIS). It is an established clinical fact that certain types of grouped microcalcifications in the breast are directly associated with malignancy at the risk profile of above 95%. The dual-mode hybrid method that Quantason is developing is an innovative one for detecting and pinpointing microcalcifications that would enable accurate minimally invasive biopsy to be performed, before a tumor is developed. Bonded with an automated system, Quantason's method, when validated clinically, would serve as an alternative or robust supplement to mammography for screening of women with dense breast tissue and intermediate risk of breast cancer. Women have understood the need for supplemental screening and advocacy groups have bombarded state legislatures with demands for access to supplemental screening with ultrasound and IDUS™-enabled stereotactic biopsies. Most recently, the significance of early detection of microcalcifications has prompted investigators to develop CT-based techniques. It is highly unlikely that CT will ever become the standard of care. IDUS™, on the other hand, is ultrasound-based and provides a superior, ionizing-radiation-free, cost-effective, age-limitation-free, reimbursable, cancer preventing screening, which will be available to all women and specifically to those with dense breasts.

We, at Quantason, are fully committed to and working to fast track the product development. I invite all readers to become part of the conversation. Together, we can elevate awareness, make preventive breast cancer care a reality, and save countless lives.