High-quality ER and PR FLEX RTU antibodies for Dako Omnis
More than 1.5 million new cases of breast cancer are diagnosed each year worldwide (1), and two-thirds of these are ER and/or PR positive. These markers are important in determining treatment options and indicating the risk of recurrence.
Created in collaboration with well-known pathologists and experts specializing in breast cancer, the new high-quality Estrogen Receptor and Progesterone Receptor antibodies provide:
Excellent specificity and sensitivity reviewed and accepted by key pathology experts
Optimized, validated protocols that are aligned to ensure the highest throughput
In the development of the new ER and PR FLEX RTU antibodies for Dako Omnis, a series of concordance studies were performed by leading pathology experts, and the new Dako Omnis ER and PR FLEX RTU antibodies demonstrate a high concordance to existing ER and PR antibodies.
The overall agreement to Agilent's existing Dako ER and PR antibodies developed for Autostainer Link 48 are 95.8% for ER and 97.6% for PR (2). Similarly, the EP1 clone has demonstrated 94.9% overall agreement to another well-established ER-clone, SP1 (3). The PR clone PgR1294, is already marketed as part of the Dako ER/PR pharmDx kit from Agilent.
"The staining was good, and I was completely satisfied since it is comparable or even better than what we are currently using.
It is very important to have reliable ER and PR test results. Without it, you are lost and the patient is lost. These markers are the most important to get right."
"It’s all about patient care, and ER in particular has a direct impact on the patient. I was impressed, and they are a great addition to the market. They should in particular help labs struggling with ER and PR consistency. These antibodies are of an excellent standard according to UK NEQAS's assessment criteria for ER and PR. Using these antibodies with the complete Dako Omnis package is preferable to mixing and matching products."
Excellent reproducibility results
Three separate sites in North America and Europe participated in a study designed to assess reproducibility within and between laboratories (inter-run and inter-lab)*. The study confirmed that the new ER and PR for Dako Omnis provided high reproducibility for enhanced patient safety and consistent and reliable results (2).
"The agreement between three different pathologists in three different countries was fantastic...a real testament to the instrument and the reagents. Given the variable tissue quality from the different institutions, the staining was remarkably good.
I cannot wait to use it in our lab. Dako Omnis was a great addition for us, and these products will be as well due to the excellent quality of these stains."
*As part of the FDA clearance process, a fourth North American site was included in the reproducibility study. Results covering all
four sites are very similar to the three-site results presented here and can be found in the Instructions for Use for GA08461-5 and
Interested in trying out the new Estrogen and Progesterone receptors in your lab?
References: (1) Ferlay J, Soerjomataram I, Ervik M, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray, F. GLOBOCAN 2012 v1.0, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11 [Internet]. Lyon, France: International Agency for Research on Cancer; 2013. Available from: http://globocan.iarc.fr, accessed on 24/January/2014. (2) Hicks D, Dell’Orto P, Falzon M, Hoff KD, Levy YY, McMahon L, et al. Immunohistochemical performance of estrogen and progesterone receptor antibodies on the Dako Omnis staining platform: evaluation in multicenter studies. Appl Immunohistochem Mol Morphol 2017;25:313-19 (3) Badve S, Vladislav T, Spaulding B, Strickland A, Hernandez S, Bird-Turner L, et al. EP1: a novel rabbit monoclonal antibody for detection of oestrogen receptor α. J Clin Pathol 2013;66:1051-57 (4) Skaland I, Nordhus M, Gudlaugsson E, Klos J, Kjellevold KH, Janssen EA, et al. Evaluation of 5 different labeled polymer immunohistochemical detection systems. Appl Immunohistochem Mol Morphol 2010;18:90-6