Nastech Pharmaceutical Company Inc has received clearance from the U.S. Food and Drug Administration (FDA) to market its non-invasive, patented Mammary Aspiration Specimen Cytology Test (MASCT) device for potential early detection of breast cancer.
The device was developed with the goal of better enabling physicians to detect atypical changes in cells lining the milk ducts - the location where an estimated 95 percent of all breast cancers originate. Nastech anticipates the MASCT will eventually become an adjunct to current standards of medical care, which include mammography and clinical breast exams.
Results from a clinical trial of healthy, non-pregnant, non-lactating, pre-menopausal female subjects, from 30 to 49 years of age, showed that the MASCT device produces results that correlate with mammogram and clinical breast exam results. In particular, the MASCT device successfully collected diagnostic amounts of Nipple Aspirate Fluid (NAF) for a conclusive cytological examination. No adverse events were reported.
"The MASCT device and kit is an important and valuable company asset with heightened commercial potential based on recent business transactions in the area of breast cancer risk assessment devices and scientific breakthroughs on the utility of mammary aspirate specimens in predicting breast cancer risk," stated Steven C. Quay, Chairman, President and Chief Executive Officer. "Nastech is now ready to initiate the next phase of the commercialization process for the product, which we obtained as part of the acquisition of Atossa HealthCare."
Nastech anticipates that its proprietary device will allow physicians to enhance breast cancer testing and compliance among patients at a lower cost than currently available options. It is anticipated that most women ages 20 and over may seek the MAS cytology test at the same time as a PAP smear test.
The device also received a United States patent on September 11, 2001. The patent, number 6,287,521, is entitled, "Methods and devices for obtaining and assaying mammary fluid samples for evaluating breast diseases, including cancer," and contains broad claims directed to a sample collection device for obtaining mammary aspirate specimens.