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deCODE genetics launches deCODE BreastCancer to assess risks of common breast cancers

DeCODE Genetics : 08 October, 2008  (New Product)
deCODE genetics has launched deCODE BreastCancer, a new tool for assessing risk of the common forms of breast cancer.
deCODE BreastCancer is a DNA-based reference laboratory test performed using a simple blood sample or cheek swab, ordered by physicians on behalf of their patients.

The common forms of breast cancer result from the interplay of genetic as well as environmental and lifestyle factors and represents 95 percent of all breast cancers. These are distinct from the rare and essentially purely inherited forms of the disease due to mutations in the BRCA1 and BRCA2 genes, which cause between one and three percent of breast cancers.

'This test is simple and compelling because it provides a woman and her doctor a means of understanding her personal risk of developing the common forms of breast cancer. This information is well-validated, relevant to the vast majority of women, and independent of family history and other known risk factors. Combined with the high public awareness of the importance of screening, advances in Magnetic resonance imaging (MRI) technology and the availability of preventive drugs targeting estrogen receptors, I believe this test will help to save lives,' said Dr Kari Stefansson, MD, Dr Med, chief executive officer of deCODE.

'DNA-based breast cancer risk assessment has to date been focused on detecting rare mutations that confer very high risk of early onset breast cancer. These are very valuable tests, but they do not measure genetic risk of the common forms of the disease. The DNA markers identified recently by deCODE represent an important step toward filling current gaps in our understanding of breast cancer risk. Ultimately, the goal is to deliver more personalised prevention and treatment for a much greater number of women,' said Rebecca Sutphen, MD, clinical geneticist at Moffitt Cancer Center and Advisory Board member at Informed Medical Decisions, a network of genetic counselors who provide support to physicians and patients using deCODE's tests.

'We speak to many people who are concerned about breast cancer through our 24/7 YourShoes Breast Cancer Support Center,' said Margaret C Kirk, chief executive officer, Breast Cancer Network of Strength (formerly known as YME National Breast Cancer Organization). 'We are very interested in all advances that could empower people to take charge of their health care and better understand their risk for developing breast cancer.'

Owen Winsett, MD, founder and director of the Breast Center of Austin, Texas, commented: 'I have followed closely the recent scientific discoveries that are incorporated into this test. I am excited to be able to extend my screening and prevention practice, because this test applies to so many more women than the BRCA1 and BRCA2 tests. My patients are eager for this type of risk information and appreciate that the test can be done with a painless inner-cheek swab. I have ordered several tests on an early-access basis and plan to make this test a standard tool for helping me to decide which of my patients may benefit from screening at an earlier age, breast MRIs, and other risk reduction measures. This test helps define individual prevention, which is what so many of my patients want.'

The deCODE BreastCancer test measures seven widely replicated single-letter variations (SNPs) in the human genome that deCODE and others have linked to risk of breast cancer. These SNPs contribute to the incidence of an estimated 60 percent of all breast cancers. The test integrates data from discovery and replication studies published in major peer-reviewed journals and involving nearly 100,000 breast cancer patients and healthy volunteers from many populations, principally of European descent. deCODE and other organizations are conducting replication studies to validate these markers in populations of other continental ancestries.

Women taking the deCODE BreastCancer test will receive a numerical score representing their relative risk of developing breast cancer in their lifetime compared to that of the general population as well as their personal lifetime risk. According to the American Cancer Society, average lifetime risk for women of European descent is 12 percent. Test scores range from 4.0 times average lifetime risk to less than half, or 0.4-times. The risk assessed by deCODE BreastCancer is independent of conventional risk factors such as family history of breast cancer in close relatives, age at first menstrual period, pregnancy history, and breast density. Therefore, this genetic risk should be viewed in the context of other risk factors assessed by a woman's physician.

deCODE BreastCancer can identify the roughly five percent of women who are at a greater than 20 percent lifetime risk of the common forms of breast cancer (about twice the average risk in the general population), and the one percent of women whose lifetime risk is roughly 36 percent (about three-times average). According to ACS guidelines, women with a lifetime risk of 20 percent or greater should receive annual MRI breast screenings in addition to mammograms, and women at 15 to 20 percent lifetime risk should talk with their doctors about the benefits and limitations of adding MRI screening to their yearly mammogram. With the information provided by the deCODE BreastCancer test, an additional 15 percent of women may fall within this range of moderately increased risk.

The test also predicts which women are more likely to develop ER-positive breast cancer if they develop cancer at all. This is important because these women may be more likely to respond to prevention strategies with drugs like tamoxifen that target oestrogen receptors. The American Society of Clinical Oncology (ASCO) recommends that women with a five-year risk of 1.66 percent or greater should be considered for preventive treatment with tamoxifen.

deCODE BreastCancer may also be used to modulate the risk profile of the early onset inherited forms of breast cancer in women who have tested positive for risk variants in the BRCA1 or BRCA2 genes.
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