This novel test identifies patients at risk of breast cancer by detecting a cancer-associated sugar in a sample of breast nipple aspirate fluid (NAF) that is derived from the mammary ducts, where a majority of breast cancers originate, and expressed through the nipple. A number of attributes position our Breast Cancer Test to be a front-line screening test. It is:

• Minimally invasive;
• Painless;
• Attractive to patients as it does not require any dietary restrictions or other preparation prior to the test;
• Easy to administer, with the sample collected by a physician during a routine check-up; and
• Cost effective.

Breast cancer is the most frequently diagnosed cancer among women. It is the second leading cause of cancer death in women, after lung cancer. In 2006, the American Cancer Society projects that about 212,920 women in the U.S. will be diagnosed with breast cancer and 40,970 will die from the disease.

When breast cancer is found at an early, localized stage, the five-year survival rate is 98%. However, early-stage breast cancer frequently has no symptoms. Common symptoms of the disease include a swelling of part of the breast, skin irritation or dimpling, nipple pain or redness, nipple discharge or a lump in the underarm area.

Numerous studies have shown that early detection of breast cancer saves lives and increases treatment options. Guidelines published by the American Cancer Society recommend an annual mammogram for women aged 40 and older and a clinical breast examination (CBE) for women in their 20s and 30s every three years and annually for women in their 40s. Breast self-examination may also help to detect changes in the breast. Emerging tools include proteomic- and genomic-based screening tests and a variety of imaging technologies.

Many of these methods, however, including mammography, are resource intensive, may not be sensitive enough to detect very early-stage disease or are too costly to serve as a front-line screening test.

A sample of breast nipple aspirate fluid is painlessly obtained during a routine physical. The sample is then placed on a proprietary membrane and sent to a laboratory.

At the laboratory, the sample is treated with the enzyme galactose oxidase and then stained with Schiff’s reagent, which produces a color change. The treated sample is read with a color reader (spectrophotometer) to quantify the color change and determine the numeric Breast Cancer Test value.