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VistaSeq Hereditary Cancer Panel

CPT: 81201; 81203; 81162; 81292; 81294; 81295; 81297; 81298; 81300; 81317; 81319; 81321; 81323; 81403; 81404(x2); 81405(x3); 81406(x4); 81408; 81479

Test Includes

The following genes are assessed: APC, ATM, BARD1, BMPR1A, BRCA1, BRCA2, BRIP1, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, FAM175A, MLH1, MSH2, MSH6, MUTYH, NBN, PALB2, PMS2, PRKAR1A, PTEN, RAD51C, RAD51D, SMAD4, STK11, TP53.


Special Instructions

A clinical questionnaire should be submitted with all specimens.


Expected Turnaround Time

21 days


Related Documents

VistaSeq - Physician Brochure VistaSeq - Patient Brochure Hereditary Cancer Family History Information Sheet VistaSeq - Informed Consent


    Specimen Requirements


    Specimen

    Blood or saliva collected in an Oragene® Dx collection kit


    Volume

    10 mL blood or 2 mL saliva


    Minimum Volume

    7 mL blood or 0.5 mL saliva


    Container

    Lavender-top (EDTA) tube or yellow-top (ACD) tube or Oragene® Dx saliva collection kit


    Collection

    Blood is collected by routine phlebotomy. Saliva is collected by spitting into the provided container until it reaches the fill line.


    Storage Instructions

    Room temperature


    Causes for Rejection

    Frozen specimen; leaking tube; clotted specimen; grossly hemolyzed specimen; incorrect anticoagulant; saliva collection in an incorrect container. Do not eat, drink, smoke, or chew gum 30 minutes prior to saliva sample collection. See Oragene Dx 500 saliva kit for detailed instructions.


    Test Details


    Use

    VistaSeq provides an assessment of inherited genetic mutations within a panel of 27 genes known to be associated with hereditary cancer syndromes.


    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 sequence analysis method used here. In addition, the presence of an inherited cancer syndrome due to a different genetic cause cannot be ruled out. Any interpretation given here should be clinically correlated with available information about presentation and the patient's relevant family history.


    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 27 cancer genes known to be involved in the development and progression of cancers are analyzed by next-generation sequencing. Flanking regions for the BRCA1 and BRCA2 genes include ±20 bp and ±10 bp for all other genes. Copy number variations are assessed by aCGH or MLPA to detect deletions and duplications.


    References

    Genetic/Familial High-Risk Assessment: Breast and Ovarian. NCCN Guidelines Version 1.2015. Available at: http://www.nccn.org/professionals/ physician_gls/pdf/genetics_screening.pdf. Accessed May 15, 2015. SGO Clinical Practice Statement: Next Generation Cancer Gene Panels Versus Gene by Gene Testing March 2014. Available at: https://www.sgo.org/clinicalpractice/guidelines/next-generation-cancer-gene-panels-versus-gene-by-gene-testing. Accessed May 18, 2015.


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