Risk Assessment

The Mammaprint test, developed by Agendia (http://www.agendia.com/pages/mammaprint/21.php), is used to predict whether early breast cancer is likely to spread (metastasize) to other parts of the body. This is accomplished by looking (at the molecular level) at the activity of 70 different genes known to be involved in the progression of cancer. The results group the cancers into 'low' or 'high' risk for spread of cancer and can be used to guide treatment decisions. The test was initially approved in 2007 (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048477.htm).

The development of accurate molecular tests for drug sensitivity and prediction of disease progression is critical. These tests have the potential to spare patients treatments that are unlikely to work for their cancer and let them begin more effective treatments immediately. Essentially, the tests allow clinicians to treat each cancer case individually. These types of test will (and already have had) have a great impact on cancer survival and quality of life for patients. The Mammaprint test, developed by Agendia (http://www.agendia.com/pages/mammaprint/21.php), is used to predict whether early breast cancer is likely to spread (metastasize) to other parts of the body. This is accomplished by looking (at the molecular level) at the activity of 70 different genes known to be involved in the progression of cancer. The results group the cancers into 'low' or 'high' risk for spread of cancer and can be used to guide treatment decisions. The test was initially approved in 2007 (http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm048477.htm).

The development of accurate molecular tests for drug sensitivity and prediction of disease progression is critical. These tests have the potential to spare patients treatments that are unlikely to work for their cancer and let them begin more effective treatments immediately. Essentially, the tests allow clinicians to treat each cancer case individually. These types of test will (and already have had) have a great impact on cancer survival and quality of life for patients.

The HALO test is meant to be used as a risk assessment tool, not a cancer detection test - it primarily meant for women under the age of about 40 (in whom routine mammography is not performed). The idea is that if there are abnormal cells lining the milk ducts, they may be detected in the fluid obtained from the test. If there are abnormal cells, that generally signifies an increased risk of developing cancer, and additional testing (perhaps MRI) may be indicated.

When properly performed, as many as 50% of women will not produce fluid with the HALO test, and in young women, this is considered a "negative" result (no abnormality). However with the normal aging process, there can be atrophy of the milk ducts, so that in women over the age of 40-50, no fluid might be due to changes related to age, and not necessarily a negative result. In addition, the HALO test will probably not pick up abnormal cells even if a cancer is present if the tumor is in the outer aspects of the breast. Lobular cancer (as it is not growing initially in the milk ducts) also will not likely be picked up with the HALO test.

The HALO test is not for everyone and again it is important to stress that this test is not meant to be a screening test for breast cancer, and is not a substitute for clinical and self-examination as well as routine imaging such as mammogram (and ultrasound / MRI if indicated). However when used appropriately it can be helpful to provide some counseling to young women regarding their risk. The HALO test is meant to be used as a risk assessment tool, not a cancer detection test - it primarily meant for women under the age of about 40 (in whom routine mammography is not performed). The idea is that if there are abnormal cells lining the milk ducts, they may be detected in the fluid obtained from the test. If there are abnormal cells, that generally signifies an increased risk of developing cancer, and additional testing (perhaps MRI) may be indicated.

When properly performed, as many as 50% of women will not produce fluid with the HALO test, and in young women, this is considered a "negative" result (no abnormality). However with the normal aging process, there can be atrophy of the milk ducts, so that in women over the age of 40-50, no fluid might be due to changes related to age, and not necessarily a negative result. In addition, the HALO test will probably not pick up abnormal cells even if a cancer is present if the tumor is in the outer aspects of the breast. Lobular cancer (as it is not growing initially in the milk ducts) also will not likely be picked up with the HALO test.

The HALO test is not for everyone and again it is important to stress that this test is not meant to be a screening test for breast cancer, and is not a substitute for clinical and self-examination as well as routine imaging such as mammogram (and ultrasound / MRI if indicated). However when used appropriately it can be helpful to provide some counseling to young women regarding their risk.