BRCAssure®: BRCA1 and BRCA2 Comprehensive Analysis

Clinical Use

Use

According to National Comprehensive Cancer Network, testing is indicated if one of the features mentioned below is present in the family: early-age-onset (age <50 years) breast cancer including both invasive and ductal carcinoma in situ (DCIS) breast cancers; two breast primaries or breast and ovarian/fallopian tube/primary peritoneal cancer in a single individual or two or more breast primaries or breast and ovarian/fallopian tube/primary peritoneal cancers in close (first- second- and third-degree) relative(s) from the same side of the family; populations at risk (eg, Ashkenazi Jewish); member of a family with a known BRCA1 or BRCA2 mutation; any male breast cancer; ovarian/fallopian tube/primary peritoneal cancer at any age.

Special Instructions

A BRCAssure® clinical questionnaire should be submitted with specimens. Contact CMBP genetics services at 800-345-4363 to coordinate testing. To order Oragene Dx 500 saliva collection kits using PeopleSoft No. 87917, contact your local Labcorp branch supply department.

Limitations

This test does not detect germline mosaicism, large chromosomal aberrations, rearrangements, gene fusions, or variants in regions not included in the analysis. Variant classification may change over time as new information becomes available. False positives or negatives may occur due to various factors, including genetic variants and technical handling errors. The assay cannot determine phase for heterozygous variants, and parental testing might be required to ascertain clinical significance. The test results should be integrated with the patient's clinical picture and family history for interpretation.

Test Details