Devices and methods for obtaining mammary fluid samples for evaluating breast diseases, including cancer

A sample collection device for collecting a biological sample from a mammary organ of a patient, comprising:

• a breast engaging member constructed of a non-porous material sized and dimensioned to receive at least a nipple portion of a breast of said patient and form a suction seal therewith;
• a solid phase sample collection medium in fluid connection with said breast engaging member for receiving a sample of expressed breast fluid;
• vacuum pump means in gaseous connection with said breast engaging member for generating negative pressure through the breast engaging member to facilitate breast fluid expression;
• and
• a hand-held breast pump incorporating said breast engaging member and vacuum pump means in a compact, structurally integrated breast fluid collection apparatus that can be manipulated and operated with one hand, wherein the hand-held breast pump comprises a fluid-retaining well comprising an integral, defined compartment or enclosure within a sample collection housing for receipt of breast fluid and/or constituent samples thereof within a removable fluid reservoir member of the sample collection housing.