New Approach To Diagnosis Of Breast Cancer Shows Promising Results

July 30, 1998

New 'Biofield' Test May Help Reduce Number Of Unnecessary Biopsies For Women With Benign Disease

A multicentre clinical study published in The Lancet* and co-ordinated by the Imperial Cancer Research Fund (ICRF) has found that a new, non-invasive diagnostic technique based on measuring electropotentials at the skin surface can help distinguish benign breast abnormalities from breast cancer. The test, developed by the US Biofield Corp. of Atlanta, Georgia, is similar to an electrocardiogram. In the study it performed best in pre-menopausal women with abnormalities detected during a breast examination by a physician.

The technique, called the Biofield Diagnostic System, has been evaluated on 661 women, at eight leading European medical centres, who had undergone biopsy for suspicious breast lesions. Dr Jack Cuzick, head of the ICRF Mathematics, Statistics and Epidemiology Laboratory, has performed an independent analysis of the findings and shown that when the system is operated at 90 per cent sensitivity, it has a specificity of 55 per cent. This means that more than half of the biopsies could have been avoided.

"This test promises to reduce the distress suffered by women with lesions detected during physical examination, especially if they are pre-menopausal, where the limitations of current diagnostic modalities are most pronounced," said Dr Cuzick. "We are also encouraged that preliminary results from more recent studies continue to confirm the findings of this study."

The diagnosis of breast cancer usually begins with the discovery of a breast lump or other abnormality through physical examination or mammography screening. Most of these suspicious lesions will prove to be benign. However, to reach a firm diagnosis, doctors will refer most of these women for further tests, including additional mammography, ultrasound, fine needle aspiration or, in some cases, surgical biopsy. This excessive testing is a result of the low specificity of current screening and diagnostic methods, especially in younger women. It causes anxiety, and wastes resources.

The new test is a non-invasive procedure that records and analyses changes in electrical charge distributions associated with the development of breast cancer. Its results can provide physicians and patients with an objective assessment of the likelihood that an abnormality identified through physical examination is malignant or benign. This, together with other clinical information, can be used by physicians when making further treatment decisions, including whether or not to proceed with a surgical biopsy.

"The largest part of my practice is treating women with suspicious lumps found during a physical examination," said Professor Ian Fentiman of the ICRF Breast Oncology Group at Guy's Hospital, a co-author of the study. "Most of these women will not ultimately have cancer, but this is often clear only after they undergo a range of diagnostic tests and in some cases biopsy. This is time-consuming, expensive and creates enormous anxiety. An approach which could avoid much of this testing would be very valuable, and I am encouraged by the promising results found in this study."

Dr Richard Davies, professor of surgery at New Jersey Medical and Dental School and chairman of the scientific advisory board of Biofield Corp. commented: "This is a completely different approach to breast cancer diagnosis. It has been known for decades that there are electrical disturbances caused by cancerous cells, and what is exciting is that this effect can be measured at the skin surface.

"These results also indicate that with certain improvements the test could be modified to be a screening test, but this application will require additional research," he added.

In the United States, Pre-Market Approval from the US Food and Drug Administration will be required prior to commercial availability. The test should be available in Europe by the end of 1998.

*Electropotential measurements as a new diagnostic modality for breast cancer. Lancet. 1 August 1998.

Note to editors: Biofield is a registered trademark of Biofield Corp.

Imperial Cancer Research Fund

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