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VistaSeq® High/Moderate Risk Breast Cancer Panel

CPT: 81162; 81307; 81321; 81323; 81351; 81404; 81405; 81406; 81408; 81479
Updated on 09/16/2021
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Synonyms

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

Test Includes

ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, PTEN, STK11 and TP53.

ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, PTEN, STK11 and TP53.


Special Instructions

A hereditary cancer clinical questionnaire should be submitted with all specimens. Contact CMBP genetic services at 800-345-4363 to coordinate testing.

A hereditary cancer clinical questionnaire should be submitted with all specimens. Contact CMBP genetic services at 800-345-4363 to coordinate testing.

A hereditary cancer clinical questionnaire should be submitted with all specimens. Contact CMBP genetic services at 800-345-4363 to coordinate testing.

A hereditary cancer clinical questionnaire should be submitted with all specimens. Contact CMBP genetic services at 800-345-4363 to coordinate testing.

A hereditary cancer clinical questionnaire should be submitted with all specimens. Contact CMBP genetic services at 800-345-4363 to coordinate testing.


Expected Turnaround Time

20 - 28 days



Specimen Requirements


Specimen

Whole blood or saliva collected in an Oragene Dx collection kit


Volume

10 mL whole blood, 2 mL saliva


Minimum Volume

7 mL whole blood, 0.5 mL saliva


Container

Lavender-top (EDTA) tube or yellow-top (ACD) tube or Oragene Dx 500 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


Stability Requirements

Temperature

Period

Room temperature

60 days

Refrigerated

60 days


Causes for Rejection

Frozen specimen; leaking tube; clotted specimen; grossly or hemolyzed specimen; quantity not sufficient for analysis; 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

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


Limitations

Sequencing cannot detect variants in regions not covered by this analysis, including noncoding or deep intronic variants and may not reliably detect changes in repetitive elements, such as microsatellite repeats. Sequencing may not detect mosaic variants, inversions, or other genomic rearrangements such as transposable element insertions. Sequence analysis may also be affected by allele drop-out due to the presence of a rare variant under a primer site or homopolymeric regions. The method does not allow any conclusion as to whether two heterozygous variants are present on the same or on different chromosome copies.

Copy number variations are assessed by microarray or multiple-ligation-probe amplification assay (MLPA) to detect gross deletions and duplications. Copy number analyses are designed to detect single exon, multi-exon, and full gene deletions or duplications. These analyses may not detect certain genomic rearrangements, such as translocations (balanced or unbalanced), inversions, or some partial exon rearrangements. This assay cannot determine exact breakpoints of deletions or duplications detected.

The presence of pseudogenes can interfere with the ability to detect variants in certain genes.

Each gene sequence is interpreted independently of all other gene sequences; however, variants in different genes may interact to cause or modify a typically monogenic disease phenotype.

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

This test is not intended to detect somatic variants. Bone marrow transplantation may affect the outcome of these results. Please contact Labcorp at 1-800-345-GENE to discuss testing options.

This test was developed and its performance characteristics determined by Labcorp. It has not been cleared or approved by the Food and Drug Administration.


Methodology

The coding region and flanking splice sites are analyzed by NGS (+/-10bp) and deletion/duplication analysis. Exon-level deletions/duplications are assessed by aCGH or by MLPA. Analysis is expanded for BRCA1/2 flanking splice sites (+/-20bp) and to include promoter sequence variants for PTEN (c.-1300 to c.-750). 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).

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 and/or by multiplex ligation-dependent probe amplification (MLPA). Genes tested in tested in this panel include ATM, BRCA1, BRCA2, CDH1, CHEK2, PALB2, PTEN, 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).

The coding region and flanking splice sites are analyzed by NGS (+/-10bp) and deletion/duplication analysis. Exon-level deletions/duplications are assessed by aCGH or by MLPA. Analysis is expanded for BRCA1/2 flanking splice sites (+/-20bp) and to include promoter sequence variants for PTEN (c.-1300 to c.-750). 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).


LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
481452 VistaSeq HR/MR Breast Cancer 73977-1 481456 Specimen Type 31208-2
481452 VistaSeq HR/MR Breast Cancer 73977-1 481457 Preauthorization N/A
481452 VistaSeq HR/MR Breast Cancer 73977-1 481458 Result Summary 51968-6
481452 VistaSeq HR/MR Breast Cancer 73977-1 481459 Result and Interpretation 69548-6
481452 VistaSeq HR/MR Breast Cancer 73977-1 481460 Recommendations 47042-7
481452 VistaSeq HR/MR Breast Cancer 73977-1 481461 Additional Information 48767-8
481452 VistaSeq HR/MR Breast Cancer 73977-1 481462 Methodology and Limitations 49549-9
481452 VistaSeq HR/MR Breast Cancer 73977-1 481463 References 75608-0
481452 VistaSeq HR/MR Breast Cancer 73977-1 481646 Director Review 72486-4
481452 VistaSeq HR/MR Breast Cancer 73977-1 481647 PDF 51969-4

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The LOINC® codes are copyright © 1994-2021, 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