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
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Test Details

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.

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.

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).

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 are 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

Collection

Blood is collected by routine phlebotomy.

Storage Instructions

Room temperature

Causes for Rejection

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

Clinical Information

Special Instructions

Test orders must include an attestation that the provider has the patient's informed consent for genetic testing. See sample physician office consent form (Informed Consent for VistaSeq℠) in Related Documents. A Hereditary Cancer Clinical Questionnaire also should be submitted with specimens. Contact CMBP genetics services at 800-345-4363 to coördinate testing.

References

Daly MB, Axilbund JE, Buys S, et al. Clinical practice guidelines in oncology. Genetic/familial high-risk assessment: Breast and ovarian. J Natl Compr Canc Netw. 2010 May; 8(5):562-594. 20495085
LaDuca H, Stuenkel AJ, Dolinsky JS, et al. Utilization of multigene panels in hereditary cancer predisposition testing: Analysis of more than 2,000 patients. Genet Med. 2014 Nov; 16(11):830-837. 24763289
Rehm HL, Bale SJ, Bayrak-Toydemir P, et al. Working Group of the American College of Medical Genetics and Genomics Laboratory Quality Assurance Committee. ACMG clinical laboratory standards for next-generation sequencing. Genet Med. 2013 Sep; 15(9):733-747. 23887774
Tung N, Battelli C, Allen B, et al. Frequency of mutations in individuals with breast cancer referred for BRCA1 and BRCA2 testing using next-generation sequencing with a 25-gene panel. Cancer. 2015 Jan 1; 121(1):25-33. 25186627

For Providers

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