Breast Cancer
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 Evaluation
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.
- Breast Cancer Panel
- High/Moderate Risk Breast Cancer Panel
- Breast and GYN Cancer Panel
- 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.
Diagnostic
Diagnostic
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)
Diagnostic
Micrometastasis Detection
Detection of metastasis in lymph nodes assists with tumor staging and therapeutic decision making.3
- Sentinel lymph node analysis by IHC
Prognostic
Prognostic
p53 by IHC
Marker of aggressiveness of disease. High expression of this marker may indicate a poor prognosis.4
Prognostic
Ki-67 by IHC
Markers of cell proliferation.5
Prognostic
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
Learn more about PIK3CA Mutation Analysis, Breast Cancer, IVD
Biomarkers for Therapeutic Selection
Biomarkers and tests for clinical management and treatment decision-making
| Test | Detects | Therapy |
|---|---|---|
| CYP2D6 Genotype | Detects nucleotide variants within the CYP2D6 gene | tamoxifen7 |
| ER by IHC | ER protein expression | Hormone therapies 7 |
| HER2 by IHC or FISH (FDA approved) | HER2 protein expression or gene amplification | trastuzumab, pertuzumab, TDM-1, lapatinib7 |
| PD-L1 by IHC (FDA-approved) | PD-L1 protein expression | pembrolizumab7 |
| PIK3CA Mutation Analysis, Breast Cancer, IVD | Mutations in the PIK3CA gene | alpelisib and fulvestrant8 |
| PR by IHC | PR protein expression | Hormone therapies7 |
| OmniSeq INSIGHT® | Includes PD-L1 IHC, DNA and RNA sequencing (523 genes), MSI, TMB*, fusion analysis including NTRK, and immune gene profiling | Targeted therapies and immunotherapies |
| MSI by PCR or Mismatch Repair (MMR) Proteins by IHC | Microsatellite instability | pembrolizumab7 |
*TMB - tumor mutational burden
Monitoring
Monitoring
CA 27.29 Antigen
For the quantitative determination of CA 27.29 antigen in serum of patients previously treated for stage II or stage III breast cancer.9
Recurrence Risk
Recurrence Risk
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.10
Learn more about Prosigna® Breast Prognostic Gene Signature Assay
References
- 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 et al. BRCA1 and BRCA2 Hereditary Breast and Ovarian Cancer. Gene Reviews. Available at: http://www.ncbi.nlm.nih.gov/books/NBK1247. Accessed July 24, 2018.
- 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.
- Butti, R., Das, S., Gunasekaran, V.P. et al. Receptor tyrosine kinases (RTKs) in breast cancer: signaling, therapeutic implications and challenges. Mol Cancer 17, 34 (2018). https://doi.org/10.1186/s12943-018-0797-x
- 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.
- National Comprehensive Cancer Network. Breast Cancer (Version 3.2022) https://www.nccn.org/professionals/physician_gls/pdf/breast.pdf
- Andre F, Ciruelos E, Rubovszky G, et al. Alpelisib for PIK3CA-mutated, hormone receptor-positive advanced breast cancer. N Engl J Med 2019;380:1929-1940.
- Chan, DW 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; 15:2322-8.
- Prosigna® Breast Cancer Prognostic Gene Signature Assay [package insert]. NanoString Technologies, Inc., Seattle, WA; 2019.