VistaSeq℠ Breast Cancer Panel

CPT: 81162; 81321; 81323; 81404; 81405(x2); 81406(x3); 81408(x2); 81479
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Test Details

Synonyms

  • Familial Cancer testing
  • Hereditary Cancer testing
  • Inherited Cancer testing

Use

This assay is intended for patients with a family history consistent with an inherited cancer syndrome.

Limitations

This assay is not designed to detect deep intronic variants, balanced translocations, large inversions, mosaicism or complex genomic rearrangements. Homopolymer regions and rare polymorphisms under primer sites can affect the performance of the assay. The presence of pseudogenes can interfere with the ability to detect variants in certain genes. This assay is not intended for use in patients who have received allogeneic bone marrow transplants, as it may not reflect the germline genetic status of these patients.

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

The entire coding region of a panel of genes related to hereditary cancer is examined by next generation sequencing analysis. Additionally, portions of the flanking noncoding regions are also examined. Comprehensive deletion/duplication testing is performed using microarray CGH for 18 genes, and by multiplex ligation-dependent probe amplification (MLPA) for the CHEK2 gene. Genes tested in panel include ATM, BARD1, BRCA1, BRCA2, BRIP1, CDH1, CHEK2, FAM175A, MRE11A, MUTYH, NF1, NBN, PALB2, PTEN, RAD50, RAD51C, RAD51D, STK11 and TP53. Clinically significant findings are confirmed by Sanger sequencing or qPCR. Results are reported using ACMG guidelines and nomenclature recommended by the Human Genome Variation Society (HGVS).

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 or hemolyzed specimen; quantity not sufficient for analysis

Clinical Information

Special Instructions

A Hereditary Cancer Clinical Questionnaire should be submitted with all specimens. Contact CMBP genetic services at 800-345-4363 to coordinate testing.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481319 VistaSeq Breast Cancer Panel 481320 Specimen Type 31208-2
481319 VistaSeq Breast Cancer Panel 481321 Preauthorization N/A
481319 VistaSeq Breast Cancer Panel 481322 Result Summary 51968-6
481319 VistaSeq Breast Cancer Panel 481323 Result and Interpretation 69548-6
481319 VistaSeq Breast Cancer Panel 481324 Recommendations 47042-7
481319 VistaSeq Breast Cancer Panel 481325 Additional Information 77202-0
481319 VistaSeq Breast Cancer Panel 481326 Methodology and Limitations 49549-9
481319 VistaSeq Breast Cancer Panel 481327 References 75608-0
481319 VistaSeq Breast Cancer Panel 481328 Director Review 72486-4
481319 VistaSeq Breast Cancer Panel 481329 PDF 51969-4
481319 VistaSeq Breast Cancer Panel 481225 VistaSeq Hered. Cancer Panel N/A

For Providers

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf