Project Summary / Abstract
This project will conduct early-stage development of a paper-based device to facilitate the efficient
recovery of high-quality nucleic acids from breastmilk for use in breast cancer risk assessment, detection
of occult disease, and epidemiologic studies designed to uncover the earliest events in the development of
breast cancer. Collecting breastmilk, which contains millions of epithelial cells from the mammary
gland, is the only noninvasive method of obtaining breast tissue. Current breastmilk collection methods
require expensive overnight shipping of breastmilk on ice and greatly limit studies using this important
biospecimen. The proposed device will facilitate the collection and loading of breastmilk on a small paper
card that can be sent through the mail and stored flat at room temperature for long periods of time, or
indefinitely, allowing subsequent recovery of nucleic acids. Because specimens can be loaded by women
in the privacy of their homes, and because the device is paper-based and inexpensive, we anticipate it will
facilitate collection of nucleic acids from the breast cells of large numbers of women in diverse geographic
While the breastmilk-collection device is inspired by blood-collection cards, it is designed to process
substantially larger volumes of breastmilk, needed to obtain a large quantity of nucleic acids required for
cancer risk assessment. The device therefore will accomplish several functions: the manipulation of
breastmilk into the paper through capillary action, the separation of excess fluid into a disposable layer
and the retention of a nucleic-rich fraction within the primary device matrix. Removal of the excess fluid
volume will expedite subsequent drying of the captured fluid and simplify transport in the event the user
cannot thoroughly dry the card before transport. The device will additionally incorporate preservatives
into the specimen to facilitate long term stability at room temperature. This program focuses on the
design of the device to facilitate retention of nucleic acids and any cells (also containing nucleic acids)
remaining unlysed in the processing window, at the same time removing excess fluid from this
component of the device. As we target a paper-based matrix, the proposed studies will focus on
evaluating the interaction of breastmilk with papers of varied pore size and surface chemistry with and
without added preservatives. These studies will enable the prioritization of materials for different
components of the device, a working configuration for the layers and other device features, and
accelerated testing to gauge the impact of extreme transport and storage temperatures.
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