FullCYTE Breast Health Test
Starting in fall/2012 to spring/2013, the National Reference Laboratory for Breast Health will be able to analyze cells from the lining of individual woman's milk ducts, collected by our patented, FDA-cleared FullCYTE Breast Health microcatheter ductal lavage system.
Breast cell collection by lavage allows focused cytological examination of specific milk ducts. To pinpoint cellular change, the FullCYTE test procedure collects exfoliated cell samples from up to seven milk ducts which are then analyzed by board-certified pathologists. We use cytopathology, multiplex proteomics, advanced genomics, and cytopathology to detect molecular changes of atypia in cells lining the milk ducts, where an estimated 95 percent of all breast cancers originate. A high risk screening tool, FullCYTE provides vital information about the condition of the cells inside a woman's individual milk ducts to evaluate a woman's personal risk for developing breast cancer and provides vital genomic information to guide prevention treatment options that are targeted and effective in the event that atypical pre-cancerous or cancerous cells are found.
Overview
The FullCYTE breast Biopsy MicroCatheter enables the collection of breast milk duct fluid for cytological evaluation. The collected fluid can be used in the determination and or differentiation of normal versus premalignant versus malignant cells. This device shoould only be used as an adjunct to standard breast cancer detection methods including mammography and physical examination.
The FullCYTE test will be available in fall/2012 to spring/2013.
Specimen
Details on specimen collection will be provided as the FullCYTE test becomes available.
Clinical and Interpretive
Details on the clinical and interpretive data will be provided as the FullCYTE test becomes available.
Performance
Details on the performance of the test will be provided as the FullCYTE test becomes available.
Coding
Details on coding will be provided as the FullCYTE test becomes available.