Personalized Health Care (PHC) in Cancer - Genomic Biomarkers for Pharmaceutical Development - page 27

TABLE 2.1 Examples of Tests to measure HER2 status in Breast Cancer [24]

Company Location Name of Test Status Technology

Biogenex InSite HER2 / neu CB11

FDA approved

Immunohistochemistry assay using a monoclonal
antibody directed against the internal domain of
HER2 / neu

Dako HER2 FISH pharmDx Kit

FDA approved

FISH assay to determine HER2 gene amplification
in FFPE breast cancer specimens. Gene
amplification = the ratio between the number
of signals from the hybridization of the HER2
gene probe and the number of signals from the
hybridization of the reference chromosome 17
probe

Dako HercepTest

FDA approved

Semi-quantitative IHC assay to determine HER2
protein overexpression in breast cancer tissues
routinely processed for histological evaluation

Genomic Health Oncotype DX

CLIA validated

RT PCR-based assay analyzing expression of a
panel of 21 genes, among them HER2. Oncotype
DX predicts disease recurrence and assesses benefit
from certain types of chemotherapy

Invitrogen SPOT-Light HER2 CISH Kit

FDA approved

Chromogenic in situ hybridization (CISH) using
a DNA probe. Quantifiable results are visualized
under a standard brightfield microscope

Monogram Biosciences HERmark Breast Cancer Assay

CLIA-validated

Proximity-based assay, which provides direct
quantitative measurements of HER2 total protein
and HER2 homodimer levels

Siemens Healthcare
Diagnostics

HER2 / neu ELISA
FDA approved

Sandwich enzyme immunoassay using mouse
monoclonal for capture and a different biotinylated
mouse monoclonal antibody for the detection of
human HER2 / neu protein. Detection is by direct
chemiluminescence. Protein is quantified by
spectrophotometry

Ventana-RocheTucson Inform HER2 Silver in situ

Hybridization
Approved in Europe but not by
FDA

Fully automated silver in situ hybridization
assay for HER2 and chromosome 17 detection.
Chromogenic signals are detected through the
use of silver deposition technology. Results and
morphological significance can be interpreted using
conventional brightfield microscopy

Ventana-Roche Pathway anti-HER2 / neu (Clone

CB11)
FDA approved

Semiquantitative immunohistochemistry assay
using a monoclonal antibody for the detection of
c-erbB-2 (HER2) antigen using Ventana's family of
automated instrument platforms

Vysis (Abbott) PathVysion HER2 DNA Probe

Kit
FDA approved

Fluorescence in situ hybridization (FISH) assay to
determine HER2 amplification, using LSI HER2
probe, which spans HER2 , and CEP 17 probe, which
hybridizes to the alpha satellite DNA located at the
centromere of the chromosome