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VistaSeq GYN Cancer Panel

CPT: Call client services

Synonyms

Familial Cancer testing, Hereditary Cancer testing, Inherited Cancer testing

Test Includes

Genes tested in this panel include BRCA1, BRCA2, CHEK2, EPCAM, MHL1, MSH2, MSH6, MUTYH, PMS2, PTEN and TP53.

Special Instructions

A clinical questionnaire should be submitted with all specimens

Expected Turnaround Time

24 - 28 days Turnaround time is defined as the usual number of days from the date of pickup of a specimen for testing to when the result is released to the ordering provider. In some cases, additional time should be allowed for additional confirmatory or additional reflex tests. Testing schedules may vary.

Specimen Requirements


Specimen

Whole blood, 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

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

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 9 genes, and by multiplex ligation-dependent probe amplification (MLPA) for the CHEK2 and PMS2 genes. Genes tested in this panel include BRCA1, BRCA2, CHEK2, EPCAM, MHL1, MSH2, MSH6, MUTYH, PMS2, PTEN 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).