|
|
BREAST CANCER SCREENING TEST TO BE SHOWCASED AT AMERICAN SOCIETY OF BREAST SURGEONS MEETING
HALO Breast Pap Provides Clinical Tool to Identify Asymptomatic High-Risk Patients for Management by Breast Specialists
PHOENIX, May 3, 2007 – Designed to detect abnormal cells in the breast, a new Pap Test for the breast may identify breast disease – often a precursor to cancer – years earlier than a lesion might be found on a mammogram or a self exam. NeoMatrix will showcase the Halo Breast Pap Test, the first automatic, noninvasive test of its kind, here at the 8th Annual Meeting of the American Society of Breast Surgeons (ASBS), May 2-6, 2007.
Drawing on the proven success of screening for cellular and biological changes that increase risk in prostate and cervical cancer, the Halo Breast Pap system collects Nipple Aspirate Fluid (NAF) using gentle suction like a breast pump. The screening occurs in the primary care setting, such as the ob-gyn, family practice, or internist office, where most women go for general healthcare. A large body of research demonstrates that the cytological assessment of breast duct fluid, or NAF, can identify a woman’s specific risk of breast cancer. For example, a woman with atypia (abnormal cytology) has a 4-5 times greater risk of developing breast cancer than women who do not produce fluid.
“Breast centers and breast specialists are expert at managing high-risk patients, but a critical problem to date has been that most women diagnosed with breast cancer have had no known risk factors; identifying asymptomatic women in the primary care setting and referring them for management by breast specialists has great potential to impact this disease,” said Matt Heindel, chief operating officer of NeoMatrix. “We are pleased that although we have just recently started discussions with the medical community, we’ve already had several surgeons or facilities agree to act as referral sources in support of local primary care practices.”
NeoMatrix has recently worked with a number of breast surgeons and breast centers to help introduce the test, including Hoag Hospital in Newport Beach, Calif., St. Joseph’s Hospital in Orange, Calif., and Dr. John West of The Breast Center in Orange, as well as Mercy Hospital in Springfield, Mass., and Griffin Hospital in Derby, Conn.
“Identifying women at risk is an important step in managing any disease and is certainly critical regarding breast cancer,” said Dr. West. “Early intervention is key to improved survival and identifying patients at risk helps with early detection. At The Breast Center, we have a protocol for managing a woman with atypia on a biopsy and will manage a patient with cellular atypia in a similar fashion.”
In its report, “The Nation’s Investment in Cancer Research 2006: Cancer Prevention, Early Detection and Prediction,” the National Cancer Institute expresses a need for more accurate methods of predicting who is at high risk for developing cancer. This is particularly important in breast cancer where more than 70 percent of women who develop cancer have no known risk factors other than age.
Since the introduction of the cervical Pap smear in the 1950s, the death rate from cervical cancer has declined over 70% through the identification of cancer causing abnormal cell development. Virtually all invasive breast cancer originates in the ductal system of the breasts and progresses through identifiable stages of development. According to a recent article in the New England Journal of Medicine, benign breast disease – which can present as abnormal cells – is an important risk factor of breast cancer.
According to Alan Hollingsworth, MD, Medical Director of Mercy Women’s Center in Oklahoma City, OK, and senior author of a 2004 report of the Breast Cancer Risk Assessment Working Group in the American Journal of Surgery, the debate and confusion over breast cancer screening tools and guidelines further illustrates the need to expand the focus from detection exclusively to include risk assessment and prevention. “The need for accurate, quantified risk assessment is gaining importance in making patient recommendations; and, the presence of atypia is one of the most significant risk factors to be included routinely in our calculations.
“The discovery of cellular atypia in the breast, as a single risk factor, is enough to prompt consideration of pharmacologic risk reduction as well as high-risk surveillance strategies with auxiliary imaging,” added Dr Hollingsworth. “When atypia is coupled with additional factors such as reproductive risks, family history, and age, patients might qualify for annual MRI screening, according to the new ACS guidelines that recommend the use of standard mathematical models to determine if the lifetime risk for breast cancer is in excess of 20%.”
About NeoMatrix, LLC
Based in Irvine, Calif., NeoMatrix© develops innovative devices that allow women and their Ob-Gyns to promote optimal breast health. The company's premier product, the HALO Breast Pap Test System, is the first fully automated, noninvasive breast disease screening device designed for use in the primary care office setting. The System has been FDA cleared for the collection of nipple aspirate fluid for cytological evaluation for the determination and/or differentiation of normal versus pre-malignant versus malignant cells. For further information, visit www.neomatrix.com.
Media Contacts:
Chris K. Joseph
510.339.2293
chris@ckjcomm.com
