03/18/2010 05:12 am ET Updated May 25, 2011

The Future Of Breast Cancer Diagnosis Is Touch

Understandably, the recent reversal of the United States Preventative Services Task Force's 1992 recommendations on mammography and subsequent reaction from the White House have elicited highly emotional reactions and caused outright confusion to women and the medical community. Although, mammography has saved countless lives, it also exposes women to radiation that increases the likelihood of developing breast cancer by 2% with each procedure.

At the heart of it, the real issue is that clearly new screening methods need to be established and supported, since our current system is risky, costly and just isn't working. New technologies have evolved that will result in a shift away from mammography as the first diagnostic tool within the next 10 years, as we have already witnessed in Australia, China and the UK.

First, let's look at what we know today:

  1. All women should be screened regardless of their overall age related risk. Cancer is the leading cause of death for women 45-54 and breast cancer is the most common form of invasive cancer.
  2. The Task Force is NOT saying that screening is unimportant, only that the risks of mammography far outweigh the benefits particularly to younger women. This is the key point in their recommendation--that mammography isn't necessarily the answer.
  3. 70% of cancers are initially found through palpation, meaning the 32 million screening mammographies in the United States only yielded 30% of the 193,000 cancers diagnosed or 58,000 mammo detected cancers.
  4. Early detection remains the best means to a good prognosis for breast cancer. This is especially true for younger women as their cancers tend to be aggressive and grow more rapidly. Younger women still have a disproportionately high mortality rate.

Millions of women are being subjected to radiation every year when they could choose an alternative screening procedure and just may not know that it exists. Radiation mutates cells which can cause cancer. Low energy x-rays used in mammograms (24 to 30 kVp) are more harmful than those of a chest x-ray (80 to 120kVp) since the high energy particles more readily pass through the body according to the US Department of Energy. In addition, while the overall dose of a screening mammography is low, (`300mrem), the dose to younger women is significantly higher (`800 to 1000 mrem) since their glandular tissue absorbs more x-rays requiring greater exposures to achieve acceptable images. Diagnostic mammography procedures and additional images push the total dose much higher.

Additionally, a high percentage of breast cancer occurs in the upper outer region of the breast. A mammography paddle cannot adequately compress that region in many women since it is limited by geometry. This is also true for small breasted women.

The medical community is still standing behind the 30 year old mammography technology despite the pain, cancer causing radiation, and a very high false positive rate. What is needed is an easy, quick and non-toxic method that has effective clinical performance. We believe that an Enhanced Clinical Breast Exam using sensory technology meets that need. Close to 40 journal publications and conference proceedings and abstracts support this technology.

Breast cancer screening facilities are closing their doors due to poor reimbursement. The operating cost to perform a screening mammography is typically over $100, but reimbursement is around $85. Many centers have to make up the losses by offering other imaging services such as follow up diagnostic imaging, ultrasound and if available, MRI. Centers in underserved communities, whose clientele cannot afford these additional services, have seen higher rates of closure. This isn't okay--all women should have access to an affordable breast cancer screening solution.

Two and a half billion dollars are being spent on mammograms for breast cancer just in the US, while only 20-30% of the cases turn out to be real cancers when the lesion is biopsied. Four patients receive unneeded overtreatment for every cancer that is found using current screening techniques.

However, women who tested positive to genetic testing (BRCA1 & BRCA2) are having preemptive mastectomies without any signs of cancer partly because their chances of getting breast cancer in their lifetime is as high as 65%. We also know that the mental stress caused by the anxiety and the repeat false positive results followed by biopsy play a major role in the decision to undergo these radical procedures. If women were provided a risk and pain free, non-invasive alternative to mammography, they would avoid these preemptive mastectomies and still have peace of mind if they could get screened at their doctor's office or purchase a home-screening device to use more regularly.

I became personally passionate and involved in creating a new screening technology after my mother was diagnosed with breast cancer over 10 years ago. (Full disclosure: I have now been issued, or am awaiting approval of, 14 patents in areas related to robotic tactile sensors that emulate the human sense of touch.) After looking into mammography and the choices women are given, I felt that I could apply my background in robotic tactile sensory systems to discovering a better alternative for detecting breast cancer in women. I am excited to say that researchers are very positive about the field of elastography where tissue hardness or elasticity is determined using stress and strain measurement techniques. It has demonstrated 90% accuracy in a dozen independent clinical studies. Elastography works because most types of breast cancers turn into a hard lesion that is up to 1000 times harder than the surrounding tissue. Doctors and women have often relied on their sense of touch, but it is difficult to communicate what one person felt and has not been considered scientific enough.

Several studies show that breast self exam isn't effective, yet the majority of breast cancers (65% - 82%) are found by women through their sense of touch. The problem is that the average size of lesions that are detected by women on their own is 2.1 cm. The average threshold trained clinician can detect lesions down to 1 cm. Tactile sensing technology can reliably detect and digitize 0.5 cm lesions without any radiation or energy being transmitted through the body. A multi-center clinical study on hundreds of women has shown it to be 90% accurate when compared with pathology results.

I believe we are well on our way to making the sense of touch more ubiquitous through tactile sensory technology. It is being widely used in Australia, China and the UK and is FDA cleared and available in the US. We have also set up the Pre-Mammogram Foundation in order to donate SureTouch systems to the underserved communities that need better screening for their women.