The ForeCYTE Breast Health test
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The ForeCYTE Breast Health Test is a simple, non-invasive test that can detect breast cancer cells at the earliest stages of disease. For women ages 50 to 73, the ForeCYTE Breast Health Test is intended to be used as a routine screen for breast cancer in addition to an annual mammogram. The test is also intended as an important tool for assessing and maintaining breast health in women between the ages of 18 and 49, for whom screening mammography is not currently recommended.
ForeCYTE versus Mammography
Mammography can only detect masses of at least 100,000,000 cells and do not provide information on the type of cell contained in the mass. In contrast, the ForeCYTE Breast Health Test collects and analyzes individual cells from breast tissue and can determine if they are normal, atypical, or malignant (cancerous). The test can detect cancer when there as few as 10 abnormal cells, enabling intervention at a much earlier stage of disease than was feasible with previous technology.
Predicting Breast Cancer Risk
In addition to detecting cancer cells, the ForeCYTE Breast Health Test also detects atypical (pre-malignant) cells. By determining the number and type of atypical cells in a patient’s sample, the ForeCYTE Breast Health Test provides important information about the risk of developing cancer in the future. A woman who has atypical findings may choose to change her lifestyle or speak with her doctor about alternative breast screening schedules in order to reduce her risk of developing breast cancer or to detect breast cancer as early as possible.
Before the availability of the ForeCYTE Breast Health Test, only 19% of physicians included in a recent survey knew their patient’s lifetime risk of breast cancer. After administering the test, 99% of physicians surveyed had the information they needed to know their patient’s lifetime breast cancer risk. The ForeCYTE Breast Health Test is the only test currently available that provides this critical information on lifetime breast cancer risk. This knowledge empowers women and their doctors to more effectively manage and protect their breast health.
Getting the ForeCYTE Breast Health Test
The ForeCYTE Breast Health Test can be administered in a physician’s office in just a few minutes. Cells and fluid that exist inside the milk duct and lobules of the breast and collected using a small pump that is applied to the outside of the patient’s nipple. This sample, known as nipple aspirate fluid (NAF), contains cells from the lining of the milk ducts and lobules. These are the types of cells from which 99% of all breast cancers originate. The NAF sample is then sent to the National Reference Laboratory for Breast Health at Atossa Genetics for analysis. This analysis uses a patented process to look for the presence or absence of specific proteins that are known to be associated with pre-malignant or malignant cells. This enables detection of breast cancer. Additionally, information on the number of pre-malignant or malignant cells and the amount of specific proteins present on these cells is used to calculate a lifetime breast cancer risk profile. After the test, patients and their doctors receive a five-page report detailing the findings of the analysis and providing a lifetime risk profile.

