Er pr pharmdx kit

Manufactured by Agilent Technologies

Sourced in Denmark

The ER/PR pharmDx™ Kit is a qualitative immunohistochemical assay used to detect the presence of estrogen receptor (ER) and/or progesterone receptor (PR) proteins in formalin-fixed, paraffin-embedded human breast cancer tissue specimens.

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Lab products found in correlation

Herceptest kit, by Agilent Technologies (2 mentions) Clone mib 1, by Agilent Technologies (1 mentions) Target retrieval solution citrate ph 6, by Agilent Technologies (1 mentions) Pathvysion her2 dna probe kit, by Abbott (1 mentions)

4 protocols using er pr pharmdx kit

Breast Cancer Biomarker Assessment

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Samples were centrally stained for ER, PR (ER/PR pharmDx™ Kit, Dako), HER2 (HercepTest™ Kit, Dako) and Ki67 (clone MIB-1, dilution 1:100, DAKO). ER and PR were scored according to the Allred scoring system and considered positive when the Allred score was 3 or above. HER2 positivity was defined as 3+ if more than 10% of cells displayed a strong complete membrane staining, according to the ASCO-CAP guidelines 2013.
All samples were stained for AP2γ (TFAP2C) by immunohistochemistry. Briefly, antigen retrieval was performed by heating in Target Retrieval Solution Citrate pH 6.0 (DAKO) using a pressure cooker for 10 min. Slides were incubated with the AP2γ primary antibody (clone 6E4/4, SantaCruz) at a dilution of 1:300 for 30 min at room temperature. The DAKO REAL™ Detection System Peroxidase/DAB+ was used with an automated protocol. Tumors were scored according to the Allred score (0–8). Tumors with scores 0–2 were defined as AP-2γ negative, while tumors with scores 3–8 were defined as AP-2γ positive. Whenever present, myo-epithelial cells served as positive internal control.

Jeselsohn R., Barry W.T., Migliaccio I., Biagioni C., Zhao J., De Tribolet-Hardy J., Guarducci C., Bonechi M., Laing N., Winer E.P., Brown M., Di Leo A, & Malorni L. (2016). TransCONFIRM: Identification of a genetic signature of response to fulvestrant in advanced hormone receptor positive breast cancer. Clinical cancer research : an official journal of the American Association for Cancer Research, 22(23), 5755-5764.

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Centralized Reassessment of Biomarkers

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Patients who had a discordant subtype classification [BluePrint vs. clinical (IHC/FISH)] were centrally re-assessed for ER, PR, and Her2.
In the central laboratory, ER and PR statuses were assessed on FFPE tissue by IHC using the ER/PR PharmDX kit (Dako, Glostrup, Denmark). Tumors were classified as ER- or PR-positive when ≥1 % invasive tumor cells showed definite nuclear staining, irrespective of staining intensity [6 (link)]. HER2 expression was evaluated with the HercepTest kit (Dako) and scored as 0, 1+, 2+, or 3+, according to the FDA scoring system. Tumors scored as 2+ were re-tested with SISH using the PathVysion HER2 DNA probe kit (Vysis-Abbott, Chicago, USA). Cases were considered HER2-positive if scored 3+ by IHC and/or amplified by SISH (ratio > 2).

Yao K., Goldschmidt R., Turk M., Wesseling J., Stork-Sloots L., de Snoo F, & Cristofanilli M. (2015). Molecular subtyping improves diagnostic stratification of patients with primary breast cancer into prognostically defined risk groups. Breast Cancer Research and Treatment, 154(1), 81-88.

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Biomarkers for HER2-Targeted Therapy Response

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Biomarkers and assays were selected based on documented evidence of association with response or resistance to HER2-targeted therapies, and, because of limitations in tissue availability, ability to reliably test minimal amounts of tissue. Hormone receptor status was established via central IHC, with Allred total score ≥3 considered ER/progesterone receptor (PR) positive (ER/PR PharmDx Kit, Dako). All assays were performed blinded to study endpoint and treatment assignment. Additional candidate biomarkers that could not be performed due to lack of sufficient tissue included RNA expression, including but not limited to molecular subtype categorization, and retrospective FISH evaluation of all samples.

Saura C., Matito J., Oliveira M., Wildiers H., Brufksy A.M., Waters S.H., Hurvitz S.A., Moy B., Kim S.B., Gradishar W.J., Queiroz G.S., Cronemberger E., Wallweber G.J., Bebchuk J., Keyvanjah K., Lalani A.S., Bryce R., Vivancos A., Eli L.D, & Delaloge S. (2021). Biomarker Analysis of the Phase III NALA Study of Neratinib + Capecitabine versus Lapatinib + Capecitabine in Patients with Previously Treated Metastatic Breast Cancer. Clinical Cancer Research, 27(21), 5818-5827.

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Immunohistochemical Evaluation of ER and PR in FFPE Tissue

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Each of the participating laboratories performed an immunohistochemical staining for ER and PR on 20 FFPE tissue sections using their own staining procedure. Next, the IHC coupes were scored by the laboratories themselves using their proper scoring system and rescored by the central lab. At the central lab scoring of the stained FFPE was performed using the Allred histomorphometrical scoring system for ER and PR, resulting in scores (intensity + proportion) from 0 to 8. Scores higher than 2 indicate a positive status [6 (link), 7 (link)].
Besides the 20 stained tissue sections, each lab also provided 20 unstained sections that were stained at the central lab using the ER/PR pharmDx kit (DAKO). This kit consists of a cocktail of two mouse monoclonal antibodies for ER, 1D5, and ER-2-123, which bind to different regions of the protein. Finally the stained sections were scored by the researcher and a trained pathologist.

Leen S., Steven V.L., Marie D.A., Valérie D., Annemie D.P., Gert V.D., Peter V.D., Luc D., Peter V, & Filip L. (2014). Study Assessing the Quality of Quantification of Estrogen Receptor Protein Expression by Immunohistochemistry and Gene Expression in Breast Cancer. Pathology Research International, 2014, 372653.

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