Noninvasive Pap Test for Breast to Be Showcased at American College of Obstetricians and Gynecologists Meeting

SAN DIEGO, May 7 /PRNewswire/ — Drawing on the record of one of the oldest and most successful models of health screening, the Cervical Pap Test, NeoMatrix will showcase its Halo(TM) Breast Pap Test System, the first automatic, noninvasive test of its kind, here at the 55th Annual Clinical Meeting of the American College of Obstetricians and Gynecologists (ACOG), May 5-9, 2007. Designed to detect abnormal cells in the breast years earlier than a lesion might be found on a mammogram or a clinical breast exam, the HALO System facilitates the identification of benign breast disease. A recent article in the New England Journal of Medicine identified benign breast disease an important risk factor for breast cancer.

In the National Cancer Institute’s report, “The Nation’s Investment in Cancer Research 2006: Cancer Prevention, Early Detection and Prediction,” the NCI 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.

The Halo Breast Pap Test System, launched commercially in January 2007, enables a noninvasive, five minute procedure that is designed to test for the presence of Nipple Aspirate Fluid (NAF). HALO Breast Pap Test screening occurs in the ob-gyn office, or other primary care setting using gentle suction like a breast pump to collect samples for laboratory analysis. Unlike current methods of breast cancer screening, which are capable of detecting tumors that have already developed, the HALO Breast Pap Test is designed to identify patients at risk before a lesion is detectable. This may be particularly useful in younger women who are not yet getting mammograms or are at an age when mammograms are not as sensitive. A large body of research demonstrates that testing for the presence of NAF and performing cytological assessment of any collected NAF, can be used to identify a woman’s specific risk of breast cancer. For example, a woman with atypia (abnormal cytology) in NAF has a 4-5 times greater risk of developing breast cancer than women who do not produce fluid.

According to the ACOG Guidelines for Women’s Health Care, Breast Disorders: “The American College of Obstetricians and Gynecologists recognizes the obstetrician-gynecologist’s role in diagnosing and treating breast disease. The College has adopted the goals of assisting and educating obstetrician-gynecologists in the diagnosis and treatment of benign beast disease and in the reduction of mortality from breast cancer.”

“The Ob-Gyn office is the ideal place for a breast screening tool as most women go there for basic healthcare. The current screening technologies are geared toward finding a lump as soon as possible, whether it be through a physical exam or with mammography; the HALO is the first device to allow the Ob-Gyn to implement a screen in their office to identify who is at risk,” says Steve Drosman, MD, a leading San Diego Ob-Gyn who has pioneered the new office-based screening method. “The HALO system provides a simple, noninvasive tool to collect ductal fluid in minutes and can easily be incorporated into a well woman visit.

“Since implementing this test, we have identified several women at risk who would otherwise remain undetected — none of whom had other risk factors,” added Dr Drosman. “By identifying these patients, we can send them to a surgeon or breast center where they can be managed as a high-risk patient, something breast specialists do routinely. The ability to identify women at risk and improve their management can have a profound impact on breast health.”

The introduction of the HALO Breast Pap Test has been compared to the introduction of the Cervical Pap Test in the 1950s, which is widely credited with reducing cervical cancer death rates by more than 70% through the identification of abnormal cells in the cervix. Breast cancer, which virtually always originates in the ductal system, develops in a similar manner to cervical cancer and progresses through identifiable cytological stages that can be detected in Nipple Aspirate Fluid. The developer of the Cervical Pap Test, Dr. George Papanicolaou, was also first to demonstrate that abnormal cells could be identified from NAF samples.

According to Dr. John West, a breast surgeon from The Breast Center in Orange, Calif.: “Identifying women at risk is an important step in managing any disease and is certainly critical with breast cancer. 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 found on a biopsy and will manage a patient with cellular atypia in a similar fashion.”

“With advancements in MRI and ultrasound, tremendous progress has been made in the early detection of breast tumors. However, these diagnostic modalities are not appropriate for screening asymptomatic women. To significantly impact mortality, we must identify who is at risk to ensure we either intervene with chemoprevention and other treatments in order to prevent cancer from developing or, through the use of these advanced imaging technologies, catch tumors at their earliest and most curable stages,” said Matt Heindel, chief operating officer of NeoMatrix. “The recent American Cancer Society breast cancer guidelines identified the need for accurate, quantified risk assessment tools to help physicians make better patient recommendations regarding surveillance and emphasized the need for MRI to be used on patients at high risk. The presence of atypia, combined with other factors, such as age and family history, might make the patient an appropriate candidate for this advanced imaging technology.

“There is overwhelming evidence of the value of NAF assessment in determining a woman’s breast cancer risk,” added Heindel. “If used regularly, like a Cervical Pap Test, we are convinced that the HALO Breast Pap gives Ob-Gyns a powerful tool and can have a profound impact on this disease.”

About NeoMatrix, LLC

Based in Irvine, Calif., NeoMatrix(C) 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 http://www.neomatrix.com/ .

NeoMatrix, LLC

CONTACT: Chris K. Joseph for NeoMatrix, LLC, +1-510-339-2293,chris@ckjcomm.com

Web site: http://www.neomatrix.com/