New Breast Cancer Screening Tests

The Halo Breast Pap Test

Breast cancer in younger women is often more aggressive and more deadly than in their older counterparts. But mammography is not as sensitive in younger women because of their denser breast tissue.While all women should perform monthly breast self examinations and have clinical breast examinations by qualified clinicians at least annually, women, especially younger women who want to assess their risk for developing breast cancer, may want to consider having the Halo Breast Pap Test.

Approved by the FDA in 2002 and widely distributed in 2005, The Halo Breast Pap Test collects nipple aspirate fluid and tests the fluid for the presence of atypical cells.  The Halo Breast Pap Test indicates that a woman is at increased risk for developing breast cancer, it does not diagnose breast cancer. Breast fluid containing atypical cells is associated with a 3-4% increased risk for developing future breast cancer.  If the woman also has a family history of breast cancer, this risk increases to 11%.

The Halo Beast Pap test is non-invasive and is performed right in the office. The system looks and acts very much like a breast pump; Breast cups with small nipple receptacles in the bases fit over the breasts. The breast cups are attached via tubing to a machine which when turned on applies a warm, gentle massage and suction to the breasts to aspirate nipple fluid. In women who produce nipple aspirate (approximately 60% of those tested) this fluid is sent for analysis. The presence of atypical cells increases risk for developing future breast cancer and women are advised accordingly.  If no atypical cells are found or if no fluid is aspirated, routine monitoring continues and it is recommended that the test be repeated annually.

The Halo Breast Pap Test is a product of NeoMatrix Breast Health Solutions

The decode Breast Cancer™ test

While women now have access to information about their potential future risk, if they want a definitive assessment of their genetic cancer risk, they may opt to have the decode Breast Cancer™ test. deCODEgenetics has created a DNA laboratory test that helps define a woman’s genetic risk for breast cancer. Taking a sample of cells from the inside of a woman’s cheek, her genes are analyzed for the seven known chromosomal variants found to increase a woman’s risk for developing breast cancer and definitive breast cancer risk is determined.

Digital Infrared Thermal Imaging (Thermography)

Mammography is currently the gold standard for breast cancer screening, detecting the majority of breast cancers in the majority of women. However, in women with very large breasts, breast implants or very dense breasts (the case in younger women) mammography is not as effective a screening tool. The widely acceptable alternative is MRI, yet the cost and radiation exposure make regular MRI’s an unacceptable routine screening tool. In women for whom mammography is not as effective a screening tool, they have the alternative of digital infrared thermal imaging or thermography.

“Thermography is not intended to replace mammography but to be used as an adjunct in women for whom mammography is just too painful, in women with prior radiation exposure or women with breast implants. Thermography provides another option for breast cancer screening.”

Thermography is a non-invasive technique that works by measuring the infrared radiation emitted from the body’s surface. It’s effective in breast cancer screening because cancer tumors generally have an increase in blood supply and this increase will show as an area of increased heat on the thermogram compared to surrounding tissues and structures. The thermogram is a series of digital images of the area in question showing the temperature gradients in that area. A breast thermogram consists of images of the front of a patient’s chest and breasts as well as lateral and oblique views of the chest and breasts.

Some researchers report sensitivity of thermography in detecting breast cancer as high as 97%. Others cite a high false positive rate because thermograms measure changes in blood flow to an area but cannot distinguish between a tumor and inflammation. Although it is FDA approved, physicians have yet to embrace thermography and routinely order it for a breast cancer screening. Physicians reason, if a suspicious area is found the patient has to have a mammogram anyway, so why not just have a mammogram in the first place? Physicians question its cost effectiveness, especially since thermograms are not covered by insurance.

As with all new things, only time will tell if thermography will become the next screening tool for breast cancer, as well as a diagnostic tool for breast cancer and other illnesses.

GeneSearch Breast Lymph Node Assay

On July 16, 2007 the U.S. Food and Drug Administration approved the GeneSearch Breast Lymph Node (BLN) assay. This new diagnostic test detects breast cancer cells greater than 0.2 millimeters in the lymph nodes indicating the disease has spread. The assay is more sensitive and more specific than current methods of detecting metastasis and is done during mastectomy surgery. Results are ready in 30-40 minutes.

Previously surgeons routinely removed all axillary lymph nodes (axillary lymph node dissection or ALND) for examination by the pathologist. ALND is a serious procedure with unwanted risks of lymphedema, restriction of arm movement and nerve damage. To better distinguish between those patients who need an ALND from those who don’t, sentinel lymph node biopsy (SLNB), a less invasive lymph node evaluation, became the standard of care. SLNB removes only the first (sentinel) axillary lymph node that filters fluid from the breast, as this node is most likely to contain cancer cells if the cancer has begun to spread. If there is no evidence of cancer in the sentinel node, it is highly unlikely that the cancer has spread to other nodes. If the sentinel node indicates the cancer has spread, additional axillary nodes will be removed and examined-typically via a subsequent surgery.

With the GeneSearch BLN assay the waiting and subsequent surgery is avoided. If metastasis is noted, the surgeon removes the lymph nodes at the time of mastectomy and completes all surgical intervention in one sitting. Post operatively, the surgeon can offer the patient a more definitive diagnosis including the stage of the cancer and immediately initiate a treatment plan. According to Veridex, the pharmaceutical company that developed GeneSearch, the assay has the potential to prevent the need for second surgeries for as many as 5,200 additional breast cancer patients in the U.S. each year.