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VistaSeq Hereditary Cancer Panel without BRCA

CPT:

81201; 81203; 81292; 81294; 81295; 81297; 81298; 81300; 81317; 81319; 81321; 81323; 81403; 81404(x2); 81405(x3); 81406(x4); 81408; 81479

VistaSeq Hereditary Cancer Panel without BRCA is a multi­gene test that detects inherited mutations in genes which have been associated with an increased risk of developing hereditary cancers syndromes. The test provides an assessment of inherited genetic mutations within a panel of 25 genes. Mutations in different genes can cause the same type of cancer; conversely, one gene may be associated with multiple hereditary cancers. NCCN Guideline® and The Society of Gynecologic Oncology (SGO) note that hereditary multi­gene panels may be an efficient and cost–effective approach to genetic cancer testing when used in appropriate clinical settings

Test Details

Use

The VistaSeq Hereditary Cancer Panel Without BRCA provides an assessment of inherited genetic mutations within a panel of 25 genes known to be associated with hereditary cancer syndromes. The test is intended for individuals who have already had a BRCA1 and BRCA2 gene assessment, but for whom results of that testing were negative and/or personal or family history warrant assessment of additional genes.

Test Includes

The following genes are assessed: APC, ATM, BARD1, BMPR1A, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, FAM175A, MLH1, MSH2, MSH6, MUTYH, NBN, PALB2, PMS2, PRKAR1A, PTEN, RAD51C, RAD51D, SMAD4, STK11, TP53.

Methodology

Next generation sequencing, array-based comparative genomic hybridization (aCGH), and multiplex ligation-dependent probe amplification (MLPA) platforms. The entire coding regions, as well as all flanking noncoding regions, of 25 cancer genes known to be involved in the development and progression of cancers is analyzed by next generation sequencing. Flanking regions for all genes include +/– 20 bp and +/– 10 bp. Copy number variations are assessed by aCGH or MLPA to detect deletions and duplications. BRCA1 and BRCA2 genes are not included in this test.

Specimen Requirements

Specimen

Whole blood

Volume

10 mL

Minimum Volume

7 mL

Container

Lavender-top (EDTA) tube or yellow-top (ACD) tube

Special Instructions

Clinical Questionnaire for VistaSeq℠ should be submitted with specimens.

Causes for Rejection

Frozen specimen; leaking tube; clotted specimen; grossly hemolyzed specimen; incorrect anticoagulant

Storage Instructions

Maintain specimen at room temperature

Additional Information

Limitations

Each gene sequence is interpreted independently of all other gene sequences. However, variants in different genes may sometimes interact to cause or modify a typically monogenic disease phenotype. It cannot be excluded that pathogenic variants were missed due to limitations inherent in the methodologies used here. In addition, the presence of an inherited cancer syndrome due to a different genetic cause can also not be ruled out. Any interpretation given here should be clinically correlated with available information about presentation and relevant family history of the patient.

 

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA).