Microarray-Tumor Reveal® FFPE

CPT: 81229
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Test Details

Synonyms

  • aCGH
  • CGH
  • CMA
  • Microarray Oncology
  • Reveal® SNP Array
  • WGA

Use

High resolution detection of genomic imbalances that may be present in neoplastic clonal evolution; provides detection of copy-neutral loss of heterozygosity (acquired uniparental disomy) associated with cancer gene mutation. The microarray will detect DNA copy-number changes at a threshold >1 Mb for deletions, >2 Mb for duplications.

Limitations

This assay does not detect balanced rearrangements and low level mosaicism, or tetraploidy.

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

Whole genome SNP copy number microarray analysis using Molecular Inversion Probe (MIP) technology optimized for highly degraded FFPE samples or degraded fixed cell pellets.

Specimen Requirements

Specimen

Formalin fixed paraffin embedded (FFPE) tissue; fixed cell pellets

Volume

One paraffin block or ten 10-micron thick section slides

Minimum Volume

Sufficient sample to obtain enough DNA to run microarray

Container

Paraffin block transport pouch

Collection

FFPE specimen should be fixed in 10% neutral-buffered formalin or formaldehyde. Cell pellet should be fixed in 3:1 methanol:acetic acid.

Storage Instructions

Room temperature

Causes for Rejection

Improperly embedded preparation; decalcified bone or bone core

Clinical Information

Special Instructions

Pertinent medical findings should accompany the test request form. If prior FISH analysis has been performed, include copy of report. Please direct questions to genetic customer service at 800-345-4363.

This assay is not approved for patients of New York State physicians.

References

Nauen D, Haley L, Lin MT, et al. Molecular analysis of pediatric oligodendrogliomas highlights genetic differences with adult counterparts and other pediatric gliomas. Brain Pathol. 2016 Mar;26(2):206-214.26206478

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
512014 Reveal(R) Tumor Paraffin 512006 Specimen Type 31208-2
512014 Reveal(R) Tumor Paraffin 512007 # of Genotyping Targets N/A
512014 Reveal(R) Tumor Paraffin 512008 Array Type N/A
512014 Reveal(R) Tumor Paraffin 512009 Diagnosis 48000-4
512014 Reveal(R) Tumor Paraffin 512010 Interpretation 62365-2
512014 Reveal(R) Tumor Paraffin 512011 Director Review 48672-0
512014 Reveal(R) Tumor Paraffin 512123 PDF 80563-0

For Providers

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2018, 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