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VistaSeq Endocrine Cancer Panel

CPT:

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Synonyms

Familial Cancer testing, Hereditary Cancer testing, Inherited Cancer testing


Special Instructions

clinical questionnaire should be submitted with all specimens



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


Test Details


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 13 genes. Genes tested in this panel include CDC73, MAX, MEN1, NF1, PRKAR1A, PTEN, RET, SDHB, SDHC, SDHD, TMEM127, TP53 and VHL. 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).


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