ER/PR pharmDx™ Interpretation Manual - Dako

ER/PR pharmDx tM overview
the ER/PR pharmDx tM Kit is a semi-quantitative
immunohistochemical (IHC) assay to identify estrogen
receptor (ER) and progesterone receptor (PR) expression
in normal and neoplastic tissues, formalin-fixed and
paraffin-embedded for histological evaluation. ER/PR
pharmDx tM specifically detects the ER alpha protein as
well as the PR protein located in the nuclei of ER and
PR-expressing cells, respectively.
Investigations into the biological mechanisms for breast
cancer have found that the growth rate is dependent on
the presence of estrogen or progesterone or both in most
breast cancers. thus, estrogen receptor and proges-
terone receptor status in breast cancer is considered to
be a validated prognostic and predictive factor for patient
management for anti-hormonal therapy. 1-5
ER/PR pharmDx tM is indicated as an aid in identifying
patients eligible for treatment with anti-hormonal or
aromatase inhibitor therapies, as well as an aid in the
prognosis and management of breast cancer.
ER/PR pharmDx Provides the Basis
for Reliable ER and PR Assessment
n FDA 510(k) cleared, standard, reproducible assay.
n new, highly specific ER antibody cocktail and PR
antibody with demonstrated sensitivity and specificity.
n optimized protocol with clinically validated scoring
system for the determination of ER/PR status
applicable in the management of breast cancer
patients. 5-9
n Concordance demonstrated between ER/PR
pharmDx tM and an established reference method
with positive/negative cut-off IHC score calibrated
using samples with known biochemical and clinical
response data. 10
n Verified cut-off IHC score for positivity for
ER/PR pharmDx tM .
n FDA clearance and confidence in test sensitivity and
specificity lessens the burden of extensive validation
by laboratory staff.
ER/PR pharmDx Interpretation Manual
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