Lab21 to market deCODE BreastCancer^™, a Genetic Test to Screen for Risk of the Most Common Forms of Breast Cancer

Lab21 is pleased to announce that it will be building on its’ strong molecular diagnostics portfolio with the addition of deCODE BreastCancer^™, which will be available across the UK and Ireland. deCODE‘s BreastCancer^™ assay can be used to predict a woman’s lifetime risk of developing breast cancer, which is compared with the average risk of breast cancer across the population. Using this data, patients at an increased risk can be identified and referred for more extensive testing if the results indicate they are at an increased risk.

Genetic tests such as this are rapidly becoming key tools in modern medicine and Lab21 already offers the commonly used analysis of the BRCA1 and BRCA2 genes which can identify those patients at risk of development of early-onset inherited breast cancer.

Dr Berwyn Clarke, Chief Science and Development Officer at Lab21 said: “This new test represents a significant step forward in the ability to predict breast cancer risk in the general population and provides physicians with a clearer understanding of the patient’s personal risk of developing this disease. Not only does it provide vital information on the 95 percent of breast cancers which result from the interaction of genetic, environmental and lifestyle factors, it can 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.”

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. Officially launched yesterday, it integrates new data from discovery and replication studies published in major peer-reviewed journals and involving nearly 100,000 breast cancer patients and healthy volunteers across many populations.

About The deCODE BreastCancer™ Test
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 5 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 1 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 additional to mammograms, and MRIs should be considered for women with lifetime risk of 15 to 20 percent. With the information provided by the deCODE BreastCancer^™ test, an additional 15 percent of women may fall within this range.

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 estrogen 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.