After more than fifty years of research, it is now recognized that virtually all breast cancers begin in the breast milk ducts. Clinical studies have also confirmed the ability to detect early cellular changes within the breast ducts — similar to the Pap test detection of early cervical cellular changes — through analysis of nipple aspirate fluid (NAF). Long-term clinical follow-up of patients has established the utility of NAF cytology to predict breast cancer risk. Additionally, NAF screening may detect a cancerous growth years before mammography or physical examination.
NeoMatrix, LLC, was a virtual company who hired us during the initial concepting phase of their project. As the primary development group, we performed all of the industrial design, mechanical and electronic engineering for the Neomatrix HALO breast cancer screening device. The HALO NAF Collection System(TM) is the first fully automated, non-invasive Nipple Aspirate Fluid (NAF) Collection device, specifically designed for use in the OB/GYN office.
The HALO System, which received FDA clearance in September 2002, is intended as a simple, reliable method for NAF collection. The collected fluid can be used in the determination and/or differentiation of normal versus pre-malignant versus malignant cells. NAF analysis may be used as an objective assessment of a patient's breast health and may detect early warning signs of ductal cellular changes. Regular assessment and tracking of cellular changes in the milk ducts, where most breast cancer begins, enables clinicians and patients the ability to routinely evaluate and manage breast cancer risk. The HALO System allows a simple, five minute, reproducible test that, when performed routinely, can help in the monitoring and assessment of intraductal changes within the breast, before a palpable tumor forms.