Invitae Hereditary Breast Cancer STAT Panel

This test analyzes well-established genes that are associated with a significantly increased risk of developing breast cancer, and for which there are medically actionable, published, evidence-based management and risk-reduction options. It is appropriate for breast cancer patients with upcoming cancer-related breast surgeries and/or treatment where genetic testing may inform decisions such as lumpectomy versus mastectomy, single versus double mastectomy, or use of other treatments (such as PARP inhibitors or other chemotherapy regimens).

Depending on the individual’s clinical and family history, a broader panel may be appropriate.

This test is specifically designed for heritable germline mutations and is not appropriate for the detection of somatic mutations in tumor tissue.

Test orders must include an attestation that the provider has the patient's informed consent for genetic testing.

This test includes the following genes: BRCA1, BRCA2, CDH1, PALB2, PTEN, STK11 and TP53.

Add-on breast cancer STAT genes ATM and CHEK2 can be included in the order via an ask on entry question (AOE).

Technologies used do not detect germline mosaicism and do not rule out the presence of large chromosomal aberrations, including rearrangements and gene fusions, or variants in regions or genes not included in this test, or possible inter/intragenic interactions between variants or repeat expansions.

Variant classification and/or interpretation may change with time if more information becomes available. False positive or false negative results may occur for reasons that include: rare genetic variants, sex chromosome abnormalities, pseudogene interference, blood transfusions, bone marrow transplantation, somatic or tissue-specific mosaicism, mislabeled samples or erroneous representation of family relationships.

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

Next-generation sequencing to identify genetic variants, including single nucleotide variants (SNVs), insertions, deletions and copy number variants (CNVs).

Confirmation of the presence and location of reportable variants is performed as needed based on stringent criteria using one of several validated orthogonal approaches.¹