Semi-Quantification of Her2/Neu Protein Expression in Formalin Fixed, Paraffin-Embedded Normal and Neoplastic Tissue

Applied Spectral Imaging

Status: Completed

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02654444

ASI-HER2-IHC

Details and patient eligibility

About

The purpose of the study is the identification and quantification of protein expression level in breast cancer tissues.

The imaging system is intended for diagnostic use as an aid to the pathologist in the detection, counting and classifying her2 immunohistochemical (IHC) stained samples.

Full description

The anti Her2/neu Kit is a semi-quantitative immunohistochemical (IHC) assay to identify the Human Epithelial growth factor receptor (Her2/neu) expression in formalin-fixed, paraffin-embedded human breast cancer tissue specimens. Results from the Her-2 test is indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the Her-2 kit provides the antibodies that offer direct visualization and semi-quantification of the HER2 protein expression through a brightfield microscope, the GenASIs GoPath system is designed to complement the routine workflow of the pathologist in the review of immunohistochemically stained histologic slides.

Enrollment: 3 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women having breast cancer aged 21 and up
• Borders of tumor nuclei are distinguishable
• Nuclei should have good integrity
• Background should not contain particles that interfere with the analysis

Exclusion criteria

• Slides that cannot be analyzed manually by Pathologist

Trial design

3 participants in 3 patient groups

GenASIs HiPath IHC #1

Description:

Expression of HER2 antibody. Semi-Quantitative value

GenASIs HiPath IHC #2

Description:

Expression of HER2 antibody. Semi-Quantitative value

GenASIs HiPath IHC #3

Description:

Expression of HER2 antibody. Semi-Quantitative value