Methods and kits for obtaining and assaying mammary fluid samples for

Abstract

Non-invasive methods and kits are provided for obtaining biological samples of mammary fluid or mammary fluid components by administering oxytocin or an oxytocin analogue to a mammalian patient to stimulate expression of mammary fluid. The oxytocin is preferably administered intranasally and causes myoepithelial contraction of target alveolar-ductal tissues of the breast. During or after mammary fluid expression, a biological sample is collected in the form of whole mammary fluid, whole cells or cellular components, other selected liquid or solid fractions of the mammary fluid, purified or bulk proteins, glycoproteins, peptides, nucleotides or other desired constituents of mammary fluid. Methods and kits are also provided for determining the presence or amount of a breast disease marker in biological samples of mammary fluid or mammary fluid components. Samples obtained according to the above sample collection methods are assayed to determine the presence and/or amount of a breast disease marker, for example a breast cancer marker such as CEA, HMFG, MCA, vasopressin, or cathepsin D, in the sample. Cellular samples obtained according to the above sample collection methods are also examined microscopically for cytological evidence of breast disease.