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2001 SEP 6 - (NewsRx Network) -- Nastech Pharmaceutical Company, Inc. (NSTK) announced findings from a clinical trial that evaluated whether useful specimens could be obtained using its noninvasive Mammary Aspiration Specimen Cytology Test (MASCT) device.
The MASCT is a noninvasive, nonpowered device that draws nipple aspirate fluid from the breast for cytological examination. The study showed that the device provides clinically useful mammary aspiration specimens for cytological examination that may prove useful in the diagnosis of breast cancer.
The device is being developed as an adjunct to current standards of medical care, which include mammography and clinical breast exams. The MASCT device is a patent-pending, modified breast pump in design, permitting the aspiration and collection of microliter quantities of fluid and designed to be conveniently operated with one hand.
The clinical trial was conducted at Nastech's clinical research unit in Stony Brook, New York, with 31 healthy, premenopausal female subjects ages 30-49 years who were not pregnant or lactating. Based on cytological evaluation and/or measurable weight changes on the sample collection membrane filter within the device, all breasts evaluated in the clinical trial with the bilateral mammary aspiration technique yielded nipple aspirate fluid. Cytological findings from the study correlated well with mammogram and clinical breast exam results. No adverse events were reported.
Following the noninvasive, 15-minute procedure, which received favorable patient and physician acceptance, the specimens were sent to a laboratory for cytological examination, a process that evaluates certain cellular changes as a precursor to, or indication of, cancer. These changes are very similar to those seen in the standard Pap smear test that is done 100 million times each year as a screen for ...