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| |  DuPont Merck Introduces New Test in the Fight Against Breast Cancer N. BILLERICA, Mass., May 27, 1997 -- Beginning today, millions of women with an abnormal mammogram have a new, much-needed adjunct in the detection of breast cancer. The U.S. Food and Drug Administration (FDA) has granted DuPont Pharma Radiopharmaceuticals, a division of The DuPont Merck Pharmaceutical Company, clearance to market Miraluma(TM) (Kit for the Preparation of Technetium Tc99m Sestamibi), the first-ever nuclear medicine test approved for breast imaging. This test is an adjunct to mammography that produces striking pictures of lesions even in the midst of difficult to image breast tissue. While x-ray mammography alone is effective in many women, in the radiographically dense breast the ability of mammography to detect some cancers is reduced. However, the unique value of the Miraluma test, as an adjunct to mammography, is the accuracy of Miraluma which is unaffected by breast density. "Implicit in this test is a call for a paradigm shift in our diagnostic approach to breast cancer. We are moving towards an approach that takes into account biological behavior of breast tissue," said Iraj Khalkhali, MD, FACR, associate professor of radiological sciences, UCLA School of Medicine, and chief, breast imaging section, Department of Radiology, Harbor-UCLA Medical Center. About the procedure The Miraluma test -- also called sestamibi breast imaging -- uses a radiopharmaceutical (or imaging agent) that is thought to accumulate in areas of increased metabolic activity in malignant cells. According to in vitro studies, the concentration of the drug is up to nine times higher in malignant cells than in normal cells. During the Miraluma test, patients receive a small or "trace" amount of the radiopharmaceutical by injection, after which the breasts are imaged with a gamma camera. The patient lies down on an imaging table and the gamma camera is positioned to provide images of the breast(s). Each view may take about 10 minutes. Total test time is between 45 minutes and one hour. The Miraluma test does not involve compressing the breasts as in a mammogram. The patient may experience a slight metallic taste after the injection of the radiopharmaceutical. A more inclusive safety net According to the American Cancer Society, increased early detection via mammography is one of the main reasons for the decline in death rates from breast cancer since 1989. Today, the overall five-year survival rate is approximately 83 percent; but the rate can be as high as 96 percent if cancer is detected early, before it has spread to other parts of the body. "At a time when the breast cancer survival rate is on the rise, we are working to motivate more women than ever before to get mammograms. Conducting the Miraluma test after inconclusive mammograms may help us catch more women in the safety net of early detection," said Amy Langer, executive director of the National Alliance of Breast Cancer Organizations (NABCO). "Women facing the possibility of breast cancer will now have a much needed option when faced with an inconclusive mammogram," said Susan T. Nemetz, vice president, DuPont Pharma Radiopharmaceuticals. About DuPont Merck Pharmaceuticals A worldwide leader in its field, DuPont Merck Pharmaceuticals has division headquarters in North Billerica, Mass. The DuPont Merck Pharmaceutical Company, headquartered in Wilmington, Del., is a worldwide research-based pharmaceutical and radiopharmaceutical company.
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