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Biofield Diagnostic System (BDS)

Introduction

The Biofield Diagnostic System (BDS) has been developed and tested by the world’s leading breast cancer specialists. It has been developed to make mammogram's and all other current breast cancer diagnostic technologies obsolete in the next generation. What separates BDS from mammogram's and other leading cancer diagnostic technology is its accuracy level. BDS can detect up to 30% of cancers (especially smaller tumors in the earlier stages) missed by mammogram's. It is totally non-evasive and painless causing women to no longer undergo unnecessary biopsies, which may be what deters some women from seeking early detection in the first place.

Technology: The state of the Art Technology BDS is a revolutionary patented system for the detection of uncontrolled cellular proliferation that is characteristic of cancer. BDS works by measuring electro potentials in the breast tissue through single-use, disposable Sensors the size of quarters placed on the breasts and connected to a portable briefcase-sized computer device.

Significant electro potential differences in different areas of the breasts are associated with rapid or abnormal growth patterns in the underlying tissue, such as those found in pre malignant and malignant lesions. Normal resting breast cells are polarized with the inside about 70mV more negative than the outside of the cell, referred to as the transmembrane potential. All cancer cells are depolarized compared to their homologous normal cells with a transmembrane difference of -55 to -20mV. When cells divide, the polarization decreases. Growth or proliferation and death (apoptosis) of normal cells are highly regulated. Cancers are defined as unregulated rapidly proliferating immortalized cells. Rapidly proliferating cells have increased Na ion permeability. Excess Na ion accumulates in the cell, while K ion decreases. Resting cancer cells are thus depolarized with a more positive electro potential than normal cells. The Goldman principle states that “motion of ions equals electric current.” The trans membrane electro potentials generated by ionic currents have been measured by using microelectrodes inserted through the cell membrane, and aid in the understanding of bio potentials and the nature of the cell processes and functions and correlate with surface measurements, such as the electrocardiogram. What is recorded by skin-surface bio potential measurements, however, is not the trans membrane potential but the signal generated externally from cells, due to the external flow of current from a region of the cell membrane having a higher voltage, to one having a lower voltage; the signal is thus due to the current flow through the conducting medium. If such a signal exists in the steady state, a direct current signal will be generated.

Detection and Diagnosis: In pre-menopausal women, breast cancer is most commonly detected when a woman or her doctor feels an abnormality in her breast by an examination of the breasts by hand. In post-menopausal women, breast cancer is most often detected by a doctor with the help of a mammogram rather than by the examination of the breast by hand. Breast cancer diagnosis is the process of identifying and evaluating a suspicious breast symptom, such as a lump, abscess or nipple discharge. The most common methods currently being used for diagnosing breast cancer are diagnostic mammography, ultrasound and biopsy.

Breast Self-Examination (B.S.E.)

The more familiar a woman is with her breasts, the better she can differentiate between normal and abnormal changes. Advocates of breast self-exam state that women should examine their breasts once a month, at different times of the month, a process which should begin with adolescence and continue throughout life. The breasts change many times not only during the course of a woman's life, but also during the month. So it is smart to check at different times every month to become most familiar with monitoring .changes in the breasts.

Advantages:

Approximately 80 percent of breast cancers found, other than by screening procedures, are found by the woman herself. Breast self exam may help a woman find breast cancer a little earlier. The earlier the diagnosis, the better the chances of survival and remission and the easier it is for cosmetic reconstruction.

Clinical Breast Examination (C.B.E.)

Clinical breast examination is similar to a breast self-exam, except that a clinical breast exam is a routine examination of a woman's breasts by a doctor or other medical professional in a medical environment. The elements of a clinical breast exam are visual observation and palpation (examination of the breast by hand), It is recommended that a woman verify that her doctor is trained in breast problems or breast cancer.

Advantages

A trained breast specialist may find a suspicious lump that may have been undetected by a woman’s self-examination.

Limitations:

Clinical breast exam produces subjective results. If a suspicious lesion is found, the woman may be subjected to painful diagnostic testing often resulting in a benign finding.

Mammography

Mammography is the process of emitting a low-dose X-ray beam through a portion of the breast while the breast is compressed between a plastic paddle and a film holder. The result is a black and white negative displaying the fatty tissue, the ducts and lobes within the breast and possibly an abnormality. Mammography is classified in two categories: screening mammography and diagnostic mammography. Screening mammography usually involves taking two pictures of each breast, one in a lateral position, the other vertical, and includes all healthy women. The American Cancer Society recommends that women 40 years and over get a mammogram once a year. The National Cancer Institute recommends that women over 50 have annual mammogram's. Women under 50 should talk with their doctor about the pros and cons of screening mammography then decide for themselves whether to undergo the procedure.

Advantages:

Mammography may detect very small, non-palpable lesions that could be benign or malignant. Mammogram's can pick up pre-cancers in certain areas. Clinical trials in screening mammography have shown a reduction in mortality from breast cancer by 30 percent in women between the ages of 50 and 69.

Limitations

Mammography is subject to interpretation. One clinical test revealed that 10 radiologists who reviewed the same set of 150 mammogram's gave significantly different diagnoses. Cancer may not be visible in women with dense breast tissue. A cancer growing near the chest wall may not be detectable on a mammogram. An average of 10 to 15 percent of tumors may not be detectable on a mammogram. This average is higher in younger women. Mammography exposes a woman to radiation. Mammogram's are not as effective for women with breast implants.

Benefits of BDS to the Patient

  1. Identifies cancers currently missed by mammography and ultrasound. Biofield currently identified 119 out of 149 cancers. Whereas the current diagnostic technique only detected 88 out of 149 cancers. (BDS) identified 30% more cancers
  2. Non-invasive, painless and objective breast cancer diagnostic test with rapid results (15 minutes)
  3. Direct scientific measurement of cellular and molecular activity of breast lesions - Detects level of cell division/proliferation.
  4. Works well in younger women where x-ray imaging has major difficulties.
  5. Safe testing allows the patient to have tests administered as frequently as needed without any risks to the patient’s health.
  6. Up to ten times less expensive than currently used breast cancer screening procedures

Benefits of BDS to the Medical Professional

  1. BDS is a PC-based device with disposable sensors
  2. 15 minute test - instant results
  3. Safe: No X-rays
  4. Office-based and easy to learn
  5. Less expensive and more convenient than existing technologies. Simple easy-to-read output/Objective patient management

Effectiveness: The (BDS) accuracy level is extremely higher than other breast cancer detection methods identifying 30 % more cancers in women currently being missed by mammogram's. Thus eliminating the risk of malpractice suits against physicians for missing a problem even with a woman’s attempts at early detection.

Expense: The (BDS) technology is up to ten times less than mammography machines and is equally more cost effective to the patient undergoing the screening.

Safety & Possible Side Effects: The Biofield Diagnostic System is safe - There is no use of radiation - No compression of the breast and virtually no pain to the patient. During clinical trials, less than 0.005% of patients reported any discomfort during the exam. Minor redness in the area of the sensor placement was reported, however, all were mild in severity. All were transient. One of these patients also had incidences of itching at two sensor sites as well as on the back. Although the multiple events in the one patient lasted for five to twelve days, the patient was successfully treated with topical vitamin E. These adverse effects were attributed to local dermal reactions to the electro conductive medium (ECM) or the acrylic adhesive material used to apply the sensors. Some discomfort to skin from removal of sensors may also be expected. One other patient experienced transient mild anxiety. The BDS is superior to existing modalities at each level of prevalence. In the grid below, we compare the BDS to the common diagnostic modalities. We use the U.S. and Europe data because the tested population is more comparable in cancer prevalence to the other studies quoted. The BDS offers clear superiority in specificity, thereby offering more definitive negative results.

Clinical Studies:

  • BDS Results
  • Increased detection of malignancy by 20-29% compared to current diagnostic technologies
  • Significant added value when combined with current diagnostic technologies
  • Significant value in the diagnosis of dense breasts
  • In younger women with dense breast tissue 5 of 10 cancers are missed by advanced diagnostics
  • Provides objective results at point of care
  • Provides immediate results - no period of uncertainty for the patient More Accurate Than other Technologies
  • Procedure Sensitivity Specificity Objective Results
  • Physical Examination 71% - 86% 20% - 60% no
  • Diagnostic Mammography 78% - 90% 20% - 40% no
  • Ultrasound 60% - 80% 38% - 74% no
  • FNA 65% - 98% 34% - 99% yes
  • Biofield 90% - 9%5 40% - 65% yes

London, United Kingdom. The initial diagnosis of breast cancer is usually made during a physical examination or from a mammogram. The majority of the lesions or masses discovered will turn out to be benign. However, to establish this fact the women involved have to go through additional diagnostic tests such as further mammography, ultrasound, fine needle aspiration or open surgical biopsy. These additional tests are expensive and anxiety-provoking. Now a team of researchers from eight European hospitals and universities reports that an energy medicine device, the Biofield Diagnostic System, can provide accurate information as to whether an abnormal breast mass is cancerous or not. The study involved 661 women with suspicious lesions who had been scheduled for surgical biopsy. Prior to the biopsy the women were tested on the Biofield device. The test involves placing electrodes (similar to those used in obtaining electrocardiograms) on the skin over the suspicious breast mass as well as around the mass and in an identical pattern on the unaffected breast. Reference electrodes are placed on the palms of the hands. Electropotential (voltage) measurements are made over a one-minute period and recorded. The researchers found a very strong correlation between the magnitude of the differences in electropotential between the involved and uninvolved breasts and the likelihood that the suspicious lesion would be cancerous (as determined by the subsequent biopsy). The researchers conclude that the Biofield test can be used to reliably rule out malignant disease with a negative predictive value as high as 99.1 per cent. The accuracy of the test is somewhat less with non- palpable lesions because of the difficulty in placing the sensors accurately.

NOTE: This study was partly funded by Biofield Corp., the manufacturer of the device. Cuzick, Jack, et al. Electropotential measurements as a new diagnostic modality for breast cancer. The Lancet, Vol. 352, August 1, 1998, pp. 359-63