Dako to Offer New Antibody in U.S. to Diagnose Breast Cancer
News Apr 08, 2013
Dako has recently received clearance from the U.S. Food and Drug Administration to sell FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor α, Clone EP1 in the United States.
The clone has been available in Europe for some time and has enjoyed widespread acceptance.
“We are very pleased to now be able to supply our customers in the United States with this high-quality antibody for estrogen receptor testing on Dako’s Autostainer Link 48,” said Karen Balstrup, global product manager, IHC Reagents, at Dako.
Research has shown that tumor growth is dependent on the presence of estrogen, progesterone or both in most breast cancers.
Estrogen receptor (ER) status in breast carcinomas is a validated prognostic and predictive factor for managing a patient’s anti-hormonal therapy.
With this important diagnostic tool from Dako, breast cancer patients can be confident they are receiving the most effective treatment for their particular type of breast cancer.
Clone EP1 shows excellent concordance with the existing ER component from 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,” said Sunil S. Badve, M.D., Department of Pathology and Laboratory Medicine, Indiana University.
Badve continued, “Compared with other established ER antibody assays this new clone is a highly sensitive and specific antibody.”
The Monoclonal Rabbit Anti-Human ER α, Clone EP1 was created by Epitomics Inc., using Epitomics’ proprietary rabbit monoclonal antibody technology covered under Patent Nos. 5,675,063 and 7,402,409.
Dako and Epitomics entered into a collaboration in 2011 which allows the companies to unite competencies to provide the anatomic pathology market with antibodies.
Researchers Develop New Method to Generate Human AntibodiesNews
Researchers hope their approach will help researchers rapidly generate therapeutic antibodies for the treatment of infectious diseases and other conditions such as cancer.READ MORE
Innate Reaction of Hematopoietic Stem Cells to Severe InfectionsNews
Researchers at the University of Zurich have shown for the first time that hematopoietic stem cells detect infectious agents themselves and begin to divide, without signals from growth factors.READ MORE
Cow Antibodies Yield Important Clues For Developing A Broadly Effective AIDS VaccineNews
The unexpected animal model is providing clues for important questions at a moment when new energy has infused HIV vaccine research.READ MORE