After 50 Year Wait, Quick and Easy Breakthrough Test Gauges Breast Cancer Risk

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According to Dana Shapiro, Director of Operations - OB/GYN Division at Acupath Laboratories, Inc, a pathology and cancer genetics laboratory, "This is an exciting breakthrough that could lead to earlier detection. Like the cervical Pap test, the HALO Breast Pap Test can identify abnormal cells years before a larger, potentially cancerous lesion might develop. Because of that, this simple test is key to improving breast cancer outcomes. The test can be done in your doctor's office as part of your annual well-woman visit."

Fifty years ago, Dr. George Papanicolaou, inventor of the Pap test for cervical cancer, identified abnormal cells in nipple aspirate fluid (NAF) from within the breast duct as an indicator of breast cancer risk. It took half-a-century to develop a test to do it quickly, easily and economically.

But if the new HALO Breast Pap Test is as successful as the Pap test for cervical cancer - which has helped reduce the cervical cancer death rate by more than 80 percent since 1958 - it may save the lives of many thousands of women.

The HALO Breast Pap Test, developed by NeoMatrix, Inc. is considered a breakthrough because it helps a doctor to determine a patient's breast cancer risk years earlier than ever before.

"This is an exciting breakthrough that could lead to earlier detection," said Dana Shapiro, Director of Operations - OB/GYN Division at Acupath Laboratories, Inc, a pathology and cancer genetics laboratory. "Like the cervical Pap test, the HALO Breast Pap Test can identify abnormal cells years before a larger, potentially cancerous lesion might develop. Because of that, this simple test is key to improving breast cancer outcomes. The test can be done in your doctor's office as part of your annual well-woman visit." Acupath is one of approximately 20 medical labs nationwide analyzing Halo Breast Pap Test biomarkers.

Breast cancer is the leading cause of death in women aged 20 to 59; one in eight women will develop it during her lifetime. Some 200,000 new cases of breast cancer are diagnosed each year; 40,000 women die of the disease annually. Seventy percent of diagnosed women have no identifiable risk factors; eight out of nine have no family history of the disease.

Mammograms and manual breast exams are the traditional ways potential breast cancer is identified. But mammograms often do not detect abnormal changes until about eight years after changes have begun to take place. And by the time a woman can actually feel a lump, the disease is no longer in its earliest, most treatable stage.

In addition, few women younger than 40 get regular mammograms. Mammograms also are generally less effective in younger women because high breast density interferes with the detection of abnormalities. Although breast cancer occurs less often in younger women than in women over 50, the disease tends to be more advanced and more aggressive, with less favorable outcomes, in younger women.

"To have a meaningful impact on breast cancer mortality, the focus must be changed from 'detect and treat,' to 'screen for risk and prevent," said Shapiro. "I'm delighted that the advanced pathology work we do at Acupath allows us to play a role in achieving this important goal."

What is the HALO Breast Pap Test?
The HALO Breast Pap Test takes five minutes. It is fully automated and non-invasive. The HALO system combines warmth, massage and suction - similar to a breast pump - to bring nipple aspirate fluid (NAF) to the surface from the milk ducts, where 95 percent of all breast cancers originate. If the patient produces fluid, the sample is sent to a lab and analyzed for cellular growth.

How many women produce fluid?
About half of all women produce fluid. Producing no fluid is considered a normal result, meaning you're at normal, not elevated, risk of developing breast cancer.

If the fluid contains normal cells, the woman's risk for breast cancer is twice the normal risk. If the fluid contains abnormal cells, her risk for breast cancer is four-to-five times the normal risk.

What if the test shows a higher-than-normal cancer risk?
If a woman receives an abnormal result, she and her doctor can develop appropriate risk reduction and monitoring strategies, which may include: lifestyle modifications concerning diet and exercise; enhanced/increased imaging; chemoprevention, such as the use of Tamoxifen, and minor surgical intervention.

Does HALO replace the mammogram?
No. The HALO test does not replace a mammogram, but complements it. The HALO Breast Pap Test is strictly a risk assessment tool, not a diagnostic test like the mammogram. Mammograms, which look for lesions, are most effective as women age. HALO is looking for abnormal cells years before they might turn into a lesion, and the test is effective in women as young as 25.

Dana Shapiro bio:
Dana Shapiro is a licensed cytotechnologist and serves as the Director of Operations for Acupath's OB/GYN Division.

About Acupath Laboratories: Acupath Laboratories, Inc. is a Plainview, New York, a pathology and cancer genetics laboratory.

About NeoMatrix: NeoMatrix, Inc. is an Irvine, Cal. company that develops innovative ways for women and their doctors to promote optimal breast health. The Halo test is the only fully automated, non-invasive breast cancer risk assessment device designed for use in the primary care setting as part of an annual well-woman office visit.

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MELISSA CHEFEC
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