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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.

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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

Learn more about BRCAssure® BRCA1/2 Analysis

Genetic Risk Testing

VistaSeq® Hereditary Cancer Panels

Learn more about VistaSeq® Hereditary Cancer Panels

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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)

Learn more about Complex Tumor Analysis by IHC


Micrometastasis Detection

Detection of metastasis in lymph nodes assists with tumor staging and therapeutic decision making.3

  • Sentinel lymph node analysis by IHC

Learn more about Micrometastasis Detection

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p53 by IHC

Marker of aggressiveness of disease. High expression of this marker may indicate a poor prognosis.4

Learn more about p53 by IHC


Ki-67 by IHC

Markers of cell proliferation.5

Learn more about Ki-67 by IHC


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

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Biomarkers for Therapeutic Selection 

Biomarkers and tests for clinical management and treatment decision-making

BRCAssure® BRCA1/2 AnalysisBRCA1 and BRCA2 gene mutationsPARP inhibitor
Cytochrome P450 2D6 GenotypingDetects nucleotide variants within the CYP2D6 genetamoxifen7
ER by IHCER protein expressionHormone therapies 8
(FDA approved), including HER2-low
HER2 protein expression or gene amplificationtrastuzumab9, 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 expressionpembrolizumab14
PIK3CA Mutation Analysis, Breast Cancer, IVDMutations in the PIK3CA genealpelisib15 and fulvestrant16
PR by IHCPR protein expressionHormone therapies7
Microsatellite Instability (MSI) by PCR or Mismatch Repair (MMR) Proteins by IHCMicrosatellite instability/mismatch repair (MMR) deficiencypembrolizumab14
OmniSeq® INSIGHTIncludes PD-L1 IHC, DNA and RNA sequencing (523 genes, including ESR1), MSI, TMB*, fusion analysis including NTRK and RET, and immune gene profilingTargeted therapies and immunotherapies
VistaSeq® Hereditary Cancer PanelsBRCA1, BRCA2 and other hereditary cancer gene mutationsPARP inhibitor

*TMB - tumor mutational burden

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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.17

Learn more about CA 27.29 Antigen


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.18

Learn more about Prosigna® Breast Prognostic Gene Signature Assay



  1. Hereditary Breast and Ovarian Cancer. Available at: Accessed June 9, 2022.
  2. 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:
  3. 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.
  4. 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
  5. 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:
  6. 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.
  7. 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
  8. 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
  9. HERCEPTIN® (trastuzumab) [package insert]. South San Francisco, CA: Genentech, Inc.; 2010.
  10. PERJETATM (pertuzumab) [package insert]. South San Francisco, CA: Genentech, Inc.; 2012.
  11. KADCYLA™ (ado-trastuzumab emtansine) [package insert]. South San Francisco, CA: Genentech, Inc.; 2013.
  12. TYKERB (lapatinib) [package insert]. Research Triangle Park, NC: GlaxoSmithKline; 2007.
  13. ENHERTU® (fam-trastuzumab deruxtecan-nxki) [package insert]. Basking Ridge, NJ: Daiichi Sankyo, Inc.; 2019.
  14. KEYTRUDA® (pembrolizumab) [package insert]. Whitehouse Station, NJ: Merck &Co., Inc.; 2021.
  15. PIQRAY® (alpelisib) [package insert]. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2019.
  16. FASLODEX® (fulvestrant) [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP; 2010.
  17. 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.1997.15.6.2322
  18. Prosigna® Breast Cancer Prognostic Gene Signature Assay [package insert]. NanoString Technologies, Inc., Seattle, WA; 2019.