CAP TODAY Pathology/Laboratory Medicine/Laboratory Management
Dako has received FDA clearance to sell its Flex monoclonal rabbit anti-human estrogen receptor alpha, clone EP1 in the United States. The clone has been available in Europe for some time. With this diagnostic tool, breast cancer patients can be confident they are receiving effective treatment for their particular type of breast cancer.
Clone EP1 shows excellent concordance with the existing estrogen receptor component of Dako’s ER/PR PharmDx kit, with an overall agreement of 97.7 percent, a strong indication that pathologists can rely on the results obtained from using this antibody.
“Clone EP1 specifically detects nuclear estrogen receptor without cytoplasmic staining and shows a high degree of concordance (greater than 95 percent) to existing clones,” Sunil S. Badve, MD, Department of Pathology and Laboratory Medicine, Indiana University, said in a statement.
The monoclonal rabbit anti-human ER alpha, clone EP1 was created by Epitomics, using Epitomics’ proprietary rabbit monoclonal antibody technology. Dako and Epitomics entered into a collaboration in 2011 that allows the companies to unite competencies to provide state-of-the-art antibodies.
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