BRCA Panel (BRCA1, BRCA2)
Order Code:
BRCAP
Test Summary
This test detects mutations in the BRCA1 and BRCA2 genes which are the most common causes of hereditary breast and ovarian cancers.
Aliases
- N/A
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) or ACD (yellow-top) tube
Minimum Volume
2 mL whole blood • 2 mL saliva • 1 buccal swab • 10 mg skin fibroblasts • 2 flasks 75% confluent
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.
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.
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.
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.
Storage
N/A
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 daysFibroblasts and skin fibroblasts
- Room temperature: 48 hours
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
2 mL saliva to "fill to" line collected in OGD-500, Oragene-Dx Collection Kit or
1 buccal swab submitted in OCD-100A buccal kit (ORAcollect-Dx Collection Kit) or
10 mg skin fibroblasts collected in sterile plastic container or
2 flasks skin fibroblasts collected in each of two separate sterile T25 culture flasks or equivalent with 80-100% confluent growth
1 buccal swab submitted in OCD-100A buccal kit (ORAcollect-Dx Collection Kit) or
10 mg skin fibroblasts collected in sterile plastic container or
2 flasks skin fibroblasts collected in each of two separate sterile T25 culture flasks or equivalent with 80-100% confluent growth
Unacceptable Specimens
Do not reject
Order Code
BRCAP
EPIC (Premier) Code
LAB6697
Includes
BRCA1 Sequencing, BRCA1 Deletion/Duplication, BRCA2 Sequencing, BRCA2 Deletion/Duplication, Comprehensive Interpretation
CPT Code
- 81162
Billing Code
- 679999
CPT Statement
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 the U.S. Food and Drug Administration. The FDA has determined that such clearance or approval is not necessary. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Physician Attestation of Informed Consent
N/A
Testing Laboratory
Quest Diagnostics Nichols Institute
33608 Ortega Highway
San Juan Capistrano CA, 92675
33608 Ortega Highway
San Juan Capistrano CA, 92675
Department
Reference Testing
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Tuesday, Thursday, Saturday; Report Available: 14 - 21 days from completed pre-authorization
Specimen Collection
Special Instructions
N/A
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) or ACD (yellow-top) tube
Minimum Volume
2 mL whole blood • 2 mL saliva • 1 buccal swab • 10 mg skin fibroblasts • 2 flasks 75% confluent
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.
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.
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.
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.
Storage
N/A
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 daysFibroblasts and skin fibroblasts
- Room temperature: 48 hours
- Refrigerated: Unacceptable
- Frozen: Unacceptable
Limitations
N/A
Other Acceptable Specimens
2 mL saliva to "fill to" line collected in OGD-500, Oragene-Dx Collection Kit or
1 buccal swab submitted in OCD-100A buccal kit (ORAcollect-Dx Collection Kit) or
10 mg skin fibroblasts collected in sterile plastic container or
2 flasks skin fibroblasts collected in each of two separate sterile T25 culture flasks or equivalent with 80-100% confluent growth
1 buccal swab submitted in OCD-100A buccal kit (ORAcollect-Dx Collection Kit) or
10 mg skin fibroblasts collected in sterile plastic container or
2 flasks skin fibroblasts collected in each of two separate sterile T25 culture flasks or equivalent with 80-100% confluent growth
Unacceptable Specimens
Do not reject
Result Information
Methodology
DNA Bait Capture • Long Range Polymerase Chain Reaction • Next Generation Sequencing • Microarray
Testing Laboratory
N/A
Reference Range
See Laboratory Report
Setup Schedule / Expected Turnaround Time
Tuesday, Thursday, Saturday; Report Available: 14 - 21 days from completed pre-authorization