Forecyte Breast Health Test
Help your patients rule out breast cancer at their annual gynecologic exam. Analogous to a pap test for breast health, the ForeCYTE Breast Health Test evaluates the health of breast ducts, lobules, and the terminal lobular ductal unit (TLDU) by analyzing the exfoliated cells in nipple aspirate fluid. The ForeCYTE test can provide vital early-detection of cancerous or pre-cancerous conditions years before they can be detected by other means. Clinically proven and and peer reviewed, the ForeCYTE test provides women aged 18 to 73 objective and actionable information to improve their breast health, using the FDA-cleared MASCT System device to collect a breast duct specimen.
The National Reference Laboratory for Breast Health is the leader in Nipple Aspirate Fluid testing. We provide comprehensive test results for Nipple Aspirate Fluid collected with the patented, FDA-cleared Atossa Genetics Mammary Aspiration Specimen Cytology Test (MASCT) system. Insightful ForeCYTE Breast Health Test lab reports integrate genetic and family history using traditional cytology and patented molecular sub-typing. We evaluate fluid samples from each breast separately; examining five proteomic biomarkers of hyperplasia and one biomarker of sample integrity for early risk assessment.
Overview
Useful for the collection of Nipple Aspirate Fluid for cytopathological, protein special stains, and multiplex immunohistochemistry testing.
The medical device used to collect this specimen has been 510(k)-cleared by the FDA. The Indication for Use of the device states: the collected fluid can be used in the determination and/or differentiation of normal versus premalignant versus malignant cells.
Method Name: Special Stain, Protein, semi-quantitative; Cytopathology, cellular enrichment; Multiplex Immunohistochemistry , computer-assisted morphometric analysis
Reporting Name: Protein, semi-quantitative; Cytopathology; Multiplex IHC, semi-quantitative, using computer-assisted technology
Ordering Mnemonic: ForeCYTE Breast Health Test
Aliases: None
Specimen
Specimen Type: Nipple Aspirate Fluid
Specimen Required: ForeCYTE patient collection flower for nanotechnology protein stain, both labeled with bar-coded specimen labels, containing patient's name, as supplied.
Container/Tube: Vial and Flower
Specimen Volume: Flower for left and right breast.
Collection Instructions: Note: Flower must be barcode labeled as to left breast and right breast, and placed in corresponding sealed bag with fixative applied.
Specimen Minimum Volume: A Flower from each breast
Reject Due: Unlabelled flowers, fixative not applied.
| Specimens other than | Nipple aspirate fluid and collection Flower |
| Anticoagulants other than | N/A |
| Hemolysis | N/A |
| Lipemia | N/A |
| Icteric | N/A |
Transport Temperature: AmbientRefrig NOFrozen NO
Clinical and Interpretive
Useful For: This test detects precancerous changes in nipple aspirate fluid. The test is frequently used to provide a personalized evaluation of the risk of developing breast cancer based on cytological and molecular biomarker changes, especially in women from 18 to 73 years of age.
Reference Values: An interpretive report will be provided
Interpretation: Immunoperoxidase-stained slides are examined microscopically by the consulting board-certified anatomic pathologist. The flower is assessed for the presence of ductal fluid using a sensitive nanotechnology-based colloidal gold protein stain. An interpretive report is provided, based on the combination of clinical and family history, cytology, multiplex immunohistochemistry, and the International Breast Cancer Risk Evaluation tool (as modeled in "Familial Breast and Ovarian Cancer: A Swedish Population-based Register Study, Anderson H et al., American Journal of Epidemiology 2000, 152: 1154-1163").
Cautions: The performance and quality of immunohistochemical (IHC) stains for nipple aspirate fluid depends critically on proper processing and fixation of tissue specimens. IHC staining of cytokeratins and p63 is especially sensitive to fixation conditions (see Specimen Required for specific handling instructions).
This test provides results on female patients only at this time.
Performance
Method Description: A multiplex immunohistochemical cocktail antibody is used. Endogenous Peroxidase is blocked initially. Following primary antibody incubation, a secondary antibody is added. The first chromogen is developed with diaminobenzadine. A second chromogen is developed with Fast Red. Finally, a counterstain is developed with Haematoxylin. The protein stain comprises a nanoparticle-sized colloidal gold staining protocol with a 1 ng/spot lower limit of detection.
Day(s) and Time(s) Test Performed: Monday through Friday, 0800-1700 PT
Analytic Time: 2 days
Maximum Laboratory Time: 7 days
Specimen Retention Time: Slides are retained according to Federal CLIA and Washington MTS regulations.
Performing Laboratory Location: National Reference Laboratory for Breast Health, 1124 Columbia St, Suite 621, Seattle WA
Coding
Test Classification: This test was developed and its performance characteristics determined by the National Reference Laboratory for Breast Health in a manner consistent with CLIA requirements. The collection of nipple aspirate fluid by the MASCT System, using the MASCT device which has been cleared by the FDA as a class II medical device. The laboratory test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information: Available upon request.