Agilent Technologies' company, Dako, has announced that US Food and Drug Administration (FDA) has given consent to sell its Clone EP1 diagnostic tool for breast cancer treatment in the US market.
The antibody, called FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EP1, is claimed to help obtain nearly true status of estrogen receptor (ER) in breast carcinomas, which is considered to be the most reliable factor to mange patient's anti-hormonal therapy.
Commenting on the development Dako global product manager at IHC Reagents Karen Balstrup said, "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".
According to Dako, Clone EP1 has an overall agreement of 97.7% in showing concordance with the existing ER component from Dako's ER/PR pharmDx Kit.
The company also said that the new tool would help physicians provide most effective treatment for particular type of breast cancer and that patients can feel confident about it.
Indiana University Pathology and Laboratory Medicine Department professor Sunil Badve said, "Clone EP1 specifically detects nuclear estrogen receptor without cytoplasmic staining and shows a high degree of concordance (greater than 95 percent) to existing clones".
Created by Epitomics using its proprietary rabbit monoclonal antibody technology, the new tool was available in Europe for some time.
Earlier in 2011, Dako collaborated with Epitomics to develop state-of-the-art antibodies for the anatomic pathology market.
