7/30/2019 HER2 IHC

1/2

HER-2 (Pathway) IHC Assay

OverviewHER-2DNA is a protein over expressed in 15-20% of breast cancers. The Pathway IHC assay (FDA approved) is intended

determine the HER-2status of breast cancer and aid in predicting disease-free and overall survival in breast cancer cases. Tassay is also indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being consider

Clinical IndicationsBreast Cancer.

Clinical UtilityAid in predicting disease-free and overall survival in patients. Assess patients for Herceptin (trastuzumab) treatment.

Methodology and InterpretationImmunohistochemistry (IHC) testing for semi-quantitative determination of the human epidermal growth factor receptor (He

neu) expression of formalin-xed parafn-embedded (FFPE) human breast cancer tissue using FDA-approved Rabbit monoclo

antibodies (PATHWAY anti-HER -2/neu

(4B5)) from the Ventana Medical System, Inc. The tests are run on the Ventana automaimmunostainer. The results are scored, interpreted and reported in adherence to the American Society of Clinical Oncolo

College of American Pathologists Guideline Recommendations for Immunohistochemical Testing of Her2 in Breast Can

(revised guidline per the 2011 ASCO/CAP Clinical Notice). Equivocal cases should be reexed to HER-2/neu FISH testing.

Assay SpecifcationsReporting

Results are reported as positive or negative forHER-2protein:

No staining

IHC 0, Negative

Faint staining in >10% of cells

IHC 1+, Trace Negative

Weak to moderate staining in >10% of cells

IHC 2+, Weakly PositiveStrong complete staining in >10% of cells

IHC 3+, Strongly Positive

Specimen Requirements

10% neutral buffered formalin-xed parafn-embedded

(FFPE) tissue.

3-5m thick FFPE sections on positively coated slides.

Stored and transported at room temperature.

Licensure

CAP (Laboratory #: 7191582, AU-ID: 1434060), CLIA (Certic#: 31D1038733), New Jersey (CLIS ID #: 0002299), New Y

State (PFI: 8192), Pennsylvania (031978), Florida (80001814

Maryland (1395)

TAT

24-48 hours

CPT Codes

88342

201 Route 17 North Rutherford NJ 07070 Ofce 201.528.9200 Fax 201.528.9201

www.cancergenetics.com

Breast

Cancer

2013 Cancer Genetics, Inc. All rights rese

Pathway is a registered trademark of Roc

Herceptin is a registered trademark of Genent

7/30/2019 HER2 IHC

2/2

201 Route 17 North Rutherford NJ 07070 Ofce 201.528.9200 Fax 201.528.9201

www.cancergenetics.com

ANATOMIC PATHOLOGY SAMPLE REPORT

Final Diagnosis: Breast Cancer Therapeutic Marker Studies by IHC Results

In-situ Ductal Carcinoma

Markers % Positive Cells Staining Intensity Interpretation

ER 60% 1+ POSITIVE

PR 90% 2+ POSITIVE

Her2/neu Score 0-1+ NEGATIVE

Comment: Positive and negative controls are satisfactory.

Time to xation and duration of xation were not provided.

Reference Range forHer2/neu Score: Reference Range for ER/PR:

Positive: 3+ Positive: >1% nuclear stain

Equivocal: 2+ Negative: