VistaSeq Hereditary Cancer Panel

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VistaSeq Hereditary Cancer Panel

VistaSeq Hereditary Cancer Panel is a multi-gene 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 27 genes. Mutations in different genes can cause the same type of cancer; conversely, one gene may be associated with multiple hereditary cancers. NCCN Guidelines® and The Society of Gynecologic Oncology (SGO) note that hereditary multi-gene panels may be an efficient and cost–effective approach to genetic cancer testing when used in appropriate clinical settings.1,2

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.

Turnaround Time

21 days

CPT

81201; 81203; 81211; 81213; 81292; 81294; 81295; 81297; 81298; 81300; 81317; 81319; 81321; 81323; 81403; 81404(x2); 81405(x3); 81406(x4); 81408; 81479

Disease

Breast Cancer

Colorectal Cancer

Different cancer types

Endometrial cancer

Ovarian Cancer

Skin Cancer

Prostate Cancer

Volume

10 mL

Container

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

Special Instructions

A 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

Room temperature

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.

Use Statement

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.

References

  1. 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.
  2. 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.

CPT Codes

The CPT codes included in this publication are in accordance with Current Procedural Terminology, a publication of the American Medical Association. CPT codes are provided here for the convenience of our clients; however, correct coding often varies from one carrier to another, and LabCorp may bill specific carriers using codes other than those shown. Clients who bill for services should verify the code(s) with the applicable payor to confirm that their use is appropriate in each case.

Profile Policy

LabCorp's policy is to provide physicians, in each instance, with the flexibility to choose appropriate tests to assure that the convenience of ordering test combinations/profiles does not prevent physicians who wish to order a test combination/profile from making deliberate informed decisions regarding which tests are medically necessary. All the tests offered in test combinations/profiles may be ordered individually using the LabCorp test request form.

Please remember that (1) when ordering tests for which Medicare or Medicaid reimbursement is sought, the physician should only order those tests that the physician believes are medically necessary for each patient, (2) that using a customized profile may result in ordering tests for which Medicare or Medicaid will deny payment, (3) that the physician should only order individual tests or a less inclusive profile where not all the tests in the customized test combination/profile are medically necessary for an individual patient, and (4) that the United States Department of Health and Human Services, Office of Inspector General, takes the position that a physician who orders medically unnecessary tests may be subject to civil penalties.

LabCorp encourages clients to contact their local LabCorp representative or LabCorp location if the testing configurations shown here do not meet individual needs for any reason, or if some other combination of procedures is desired.

Investigational Procedures

Some of the individual tests and profile test components listed in this Directory may be considered by Medicare or other insurance carriers as investigational procedures, and therefore, the test may not be payable by the carrier as a covered benefit for the patient. Medicare patients must be informed of this possibility when the physician orders tests that may fall into this category. Affected patients must be asked to sign an Advance Beneficiary Notice, agreeing to be financially responsible if the service is denied by the carrier. Additionally, for other insurance plans, physicians should inform the patient that the service(s) may not be covered by their private insurance plan and, if so, they will be financially responsible for payment. If the patient declines to accept financial responsibility, please do not order the test(s).

As with all clinical assays, results of these tests should be used only in conjunction with other medically established diagnostic elements (eg, symptoms, history, clinical impressions, results from other tests, etc). Physicians should use all the information available to them to diagnose and determine appropriate treatment for their patients. In order to obtain a current list of the procedures that may be considered investigational by Medicare or other insurance carriers, please contact your local LabCorp representative.