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BRCAvantage® 11 (Client 2575, 52470, 58267 and 6374)
Test Code37181
CPT Codes
Restricted Client Code
Includes
Path Variant, Variant 1, Variant 2, Variant 3, VUS
If "Result" is positive, cascading reflex to Path Variant, Variant 1, Variant 2, Variant 3 and VUS will be performed as needed.
If "Result" is positive, cascading reflex to Path Variant, Variant 1, Variant 2, Variant 3 and VUS will be performed as needed.
Preferred Specimen
5 mL whole blood collected in an EDTA (lavender-top) tube, 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
2 flask (75% confluent minimum) skin fibroblasts
2 mL saliva
1 buccal swab
10 mg skin fibroblasts
2 flask (75% confluent minimum) skin fibroblasts
Other Acceptable Specimens
2 mL saliva to "fill to" line collected in OGD-500, OrageneDx 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 T-25 culture flasks
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 T-25 culture flasks
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.
Transport Temperature
Room temperature
Specimen Stability
Whole blood
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Saliva /Buccal swab
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days
Skin Fibroblasts
Room temperature: 48 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Saliva /Buccal swab
Room temperature: 14 days
Refrigerated: 14 days
Frozen: 14 days
Skin Fibroblasts
Room temperature: 48 hours
Refrigerated: Unacceptable
Frozen: Unacceptable
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Do not reject
Methodology
Massively Parallel Sequencing
Setup Schedule
Set up: Tues, Thurs, Sat; Report available: 14-21 days
Clinical Significance
This panel provides comprehensive analysis of 34 hereditary cancer predisposition genes related to breast, ovarian, colon, skin and other cancer types to guide management. It is intended for use in both male and female patients with personal history of early onset cancer, a rare cancer, bilateral cancer, or multiple primary cancers, with family history of multiple generations of cancers, or when suspected genetic explanations are not covered by a targeted panel.
