Labcorp Oncology offers a comprehensive test menu to assist in the diagnosis and management of patients with breast cancer throughout their continuum of care.
Genetic Risk Assessment
Genetic Risk Testing
BRCAssure® BRCA1/2 Analysis
- Mutations in BRCA1 and BRCA2 account for the vast majority of families with hereditary breast and ovarian cancer syndrome (HBOC).1
- 60% to 80% of breast cancers in women with a BRCA1 mutation are triple negative.1
- The estimated lifetime risk for breast and ovarian cancer is significantly increased in women with BRCA1/2 mutations.1
- Both men and women with mutations in BRCA1/2 may also be at increased risk of other cancers, including pancreatic, prostate, and melanoma.2
Genetic Risk Testing
VistaSeq® Hereditary Cancer Panels
- VistaSeq Hereditary Cancer Panels provide an assessment of genetic mutations known to be associated with hereditary cancer syndromes.
- Genetic tests, like VistaSeq and BRCAssure, inform a patient's risk of cancer and may guide therapy for patients with cancer.
- Mutation-specific sequencing for patients with a family history of known germline mutations.
Complex Tumor Analysis by IHC
Our extensive antibody library and team of pathologists can provide a differential diagnostic analysis in even the most difficult cases.
- Breast: in situ vs. invasive
- Breast: ductal vs. lobular
- TriView Breast (microinvasion) (triple stain CK5/p63/LMW)
Detection of metastasis in lymph nodes assists with tumor staging and therapeutic decision making.3
- Sentinel lymph node analysis by IHC
p53 by IHC
Marker of aggressiveness of disease. High expression of this marker may indicate a poor prognosis.4
Ki-67 by IHC
Markers of cell proliferation.5
PIK3CA Mutation Analysis, Breast Cancer, IVD
PIK3CA mutations are a key driver of breast cancer and have typically been associated with a poor prognosis.6
Biomarkers for Therapeutic Selection
Biomarkers and tests for clinical management and treatment decision-making
|BRCAssure® BRCA1/2 Analysis||BRCA1 and BRCA2 gene mutations||PARP inhibitor|
|Cytochrome P450 2D6 Genotyping||Detects nucleotide variants within the CYP2D6 gene||tamoxifen7|
|ER by IHC||ER protein expression||Hormone therapies 8|
|HER2 by IHC or FISH|
(FDA approved), including HER2-low
|HER2 protein expression or gene amplification||trastuzumab9, pertuzumab10, TDM-111, lapatinib12, trastuzumab deruxtecan13|
|Labcorp® Plasma Focus™||33 actionable or clinically relevant genes for somatic single nucleotide variants (SNVs) and insertions/deletions (indels)||Targeted therapies|
|PD-L1 by IHC|
|PD-L1 protein expression||pembrolizumab14|
|PIK3CA Mutation Analysis, Breast Cancer, IVD||Mutations in the PIK3CA gene||alpelisib15 and fulvestrant16|
|PR by IHC||PR protein expression||Hormone therapies7|
|Microsatellite Instability (MSI) by PCR or Mismatch Repair (MMR) Proteins by IHC||Microsatellite instability/mismatch repair (MMR) deficiency||pembrolizumab14|
|OmniSeq® INSIGHT||Includes PD-L1 IHC, DNA and RNA sequencing (523 genes, including ESR1), MSI, TMB*, fusion analysis including NTRK and RET, and immune gene profiling||Targeted therapies and immunotherapies|
|VistaSeq® Hereditary Cancer Panels||BRCA1, BRCA2 and other hereditary cancer gene mutations||PARP inhibitor|
*TMB - tumor mutational burden
Prosigna® Breast Prognostic Gene Signature Assay
Prosigna is an FDA 510(k) cleared assay that provides a risk category (low, intermediate, high) and a numerical score (0-100) for the assessment of distant recurrence of disease at 10-years for postmenopausal women with early stage, hormone receptor-positive, invasive breast cancer.18
- Hereditary Breast and Ovarian Cancer. Cancer.net. Available at: https://www.cancer.net/cancer-types/hereditary-breast-and-ovarian-cancer. Accessed June 9, 2022.
- Petrucelli N, Daly MB, Pal T. BRCA1- and BRCA2-Associated Hereditary Breast and Ovarian Cancer. 1998 Sep 4 [Updated 2022 May 26]. In: Adam MP, Mirzaa GM, Pagon RA, et al., editors. GeneReviews® [Internet]. Seattle (WA): University of Washington, Seattle; 1993-2023. Available from: https://www.ncbi.nlm.nih.gov/books/NBK1247/
- Shinozaki M, Hoon DS, Giuliano AE, Hansen NM, Wang HJ, Turner R, Taback B. Distinct hypermethylation profile of primary breast cancer is associated with sentinel lymph node metastasis. Clin Cancer Res. 2005 Mar 15;11(6):2156-62. doi: 10.1158/1078-0432.CCR-04-1810. PMID: 15788661.
- Horne GM, Anderson JJ, Tiniakos DG, et al. p53 protein as a prognostic indicator in breast carcinoma: a comparison of four antibodies for immunohistochemistry. Br J Cancer. 1996;73(1):29-35. doi:10.1038/bjc.1996.6
- Dowsett M, Smith IE, Ebbs SR, et al. Prognostic value of Ki67 expression after short-term presurgical endocrine therapy for primary breast cancer. J Natl Cancer Inst 2007; 99:167-170. Available at: http://www.ncbi.nlm.nih.gov/pubmed/17228000.
- Aleskandarany, MA, Rakha, EA, Ahmed MAH, et al. PIK3CA expression in invasive breast cancer: a biomarker of poor prognosis. Breast Cancer Res Treat. 2010;122(1):45-53. doi:10.1007/ s10549-009-0508-9.
- Goetz MP, Sangkuhl K, Guchelaar HJ, et al. Clinical Pharmacogenetics Implementation Consortium (CPIC) Guideline for CYP2D6 and Tamoxifen Therapy. Clin Pharmacol Ther. 2018;103(5):770-777. doi:10.1002/cpt.1007
- Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer [published correction appears in Arch Pathol Lab Med. 2010 Aug;134(8):1101]. Arch Pathol Lab Med. 2010;134(6):907-922. doi:10.5858/134.6.907
- HERCEPTIN® (trastuzumab) [package insert]. South San Francisco, CA: Genentech, Inc.; 2010.
- PERJETATM (pertuzumab) [package insert]. South San Francisco, CA: Genentech, Inc.; 2012.
- KADCYLA™ (ado-trastuzumab emtansine) [package insert]. South San Francisco, CA: Genentech, Inc.; 2013.
- TYKERB (lapatinib) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007.
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2019.
- KEYTRUDA® (pembrolizumab) [package insert]. Whitehouse Station, NJ: Merck &Co., Inc.; 2021.
- PIQRAY® (alpelisib) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019.
- FASLODEX® (fulvestrant) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2010.
- Chan DW, Beveridge RA, Muss H, et al. Use of Truquant BR radioimmunoassay for early detection of breast cancer recurrence in patients with stage II and stage III disease. J Clin Oncol. 1997;15(6):2322-2328. doi:10.1200/JCO.19220.127.116.112
- Prosigna® Breast Cancer Prognostic Gene Signature Assay [package insert]. NanoString Technologies, Inc., Seattle, WA; 2019.