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Hereditary Breast Cancer Panel
Test CodeHBCP
Alias/See Also
38621
CPT Codes
81432, 81433
Includes
ATM, BARD1, BRCA1, BRCA2, CHEK2, CDH1, EPCAM, MLH1, MSH2, MSH6, NF1, PALB2, PMS2, PTEN, RAD51C, RAD51D, STK11, and TP53
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) or ACD (yellow-top) tube
Patient Preparation
Saliva: Do not eat, drink, smoke or chew gum for 30 minutes before collection.
Buccal swab: Please refer to user instructions provided with kit. Ensure the sponge tip does not come into contact with any surface prior to collection. Do not eat, drink, smoke, or chew gum for 30 minutes before collection. Do not touch swab tips or allow contact with any other object.
Minimum Volume
2 mL whole blood • 2 mL saliva • 1 buccal swab • 10 mg skin fibroblasts
Other Acceptable Specimens
2 mL saliva to "fill to" line collected in OGD-500, OrageneDx collection kit • 1 buccal swab submitted in OCD-100A buccal kit (ORAcollect-DX collection kit) • 10 mg skin fibroblasts collected in sterile plastic container • 2 flasks (2 flasks 75% confluent minimum) skin fibroblasts collected in each of two separate sterile T-25 culture flasks or equipment with 80-100% confluent growth
Instructions
Do not hold specimen. Forward to laboratory when specimen arrives.
Whole blood (preferred): Normal phlebotomy procedure. Specimen stability is crucial. Store and ship room temperature immediately. Do not freeze.
Saliva: 2 mL saliva collected in the Oragene-Dx collection kit up to the "fill to" line (OGD-500/OGD-600, OGD-510/OGD-610). Do NOT remove the plastic film from the funnel lid.
For fibroblasts and skin fibroblasts, call 1-866-GENEINFO (1-866-436-3463) prior to collecting and ordering.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Saliva or buccal swab
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days
Fibroblasts and skin fibroblasts
Room temperature: 48 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Saliva or buccal swab
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days
Fibroblasts and skin fibroblasts
Room temperature: 48 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Do not reject. Forward to performing laboratory for evaluation of sample.
Methodology
DNA Bait Capture • Long Range Polymerase Chain Reaction • Next Generation Sequencing • Microarray
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Tuesday, Thursday, Saturday Morning Report available: 15 Days after receipt at the performing laboratory. Add three (3) days for transport.
Reference Range
See Laboratory Report
Clinical Significance
The Hereditary Breast Cancer Panel includes 18 genes associated primarily with hereditary breast and possibly other cancers. This can include, but is not limited to, cancers of the breast, colon, endometrium, stomach, urinary tract, ovary, pancreas, prostate, and other tissues. Individuals with a positive result (pathogenic or likely pathogenic variant detected) have an increased risk for developing certain cancers relative to that of the general population.
Performing Laboratory
Quest Diagnostics Nichols Inst San Juan Capistrano
33608 Ortega Highway
San Juan Capistrano, CA 92690-6130
Last Updated: May 5, 2023