BRCAvantage® with reflex Breast Plus Panel (Client 6374, 58267)

Test Code

37224

CPT Codes
81351, 81479, 81321, 81323, 81406, 81479, 81405, 81404, 81307, 81479<br>Restricted Client Code

Includes

Positive for a known pathogenic mutation; positive for a likely pathogenic mutation; positive for a likely pathogenic mutation and a variant with unknown significance, then TP53, PTEN, CDH1, STK11, and PALB2 will be performed at an additional charge.

Preferred Specimen

4 mL whole blood collected in an EDTA (lavender-top) tube, ACD solution A (yellow-top) tube or ACD solution B (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 flasks 75% confluent 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 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: 8 days
Refrigerated: 8 days
Frozen: Unacceptable

Saliva or 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
Next Generation Sequencing (NGS) • Multiplex Ligation-dependent Probe Amplification (MLPA) • Exon Capture

Setup Schedule

Set up: Tues, Thurs, Sat; Report available: 12 days from completed pre-authorization

Clinical Significance

Approximately 5-10% of breast cancer cases are
hereditary. BRCA1 and BRCA2 account for 15-20% of
hereditary breast cancers. Five additional breast cancer
susceptibility genes include CDH1, PALB2, PTEN, STK11 and
TP53. Sequence analysis and deletion/duplication analysis
of these five genes can explain an additional 3% to 4.5%
of hereditary breast cancers.

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.