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Clinical immunophenotyping using the CyAn DXD flow cytometer, a lyse wash sample preparation method, for identification and enumeration of CD3, CD4 and CD8 lymphocyte subsets using TC-660. For In-Vitro Diagnostic Use

The Dako CyAn™ DXD device is a bench-top flow cytometer system relying on multiple (up to three) laser stimulation of fluorescence tagged lymphocytes. It is used with the Dako MultiMix, a triple color reagent; one each to CD3, CD4 and CD8, conjugated to fluorochromes APC(allophycocyanin), r-phycoerythrin, and fluorescein isothiocynate, which are balanced to identify the dual positive T-cell populations (CD3+CD4+ and CD3+CD8+) in peripheral blood lymphocytes. The instrument requires daily set-up with Dako FluoroSpheres consisting of a set of 5 bead populations having different fluorescent intensities and one nonfluorescent bead population. The combination of fluorochromes enables excitation by light of any wavelength from 365-650 nm. The CyAn DXD utilizes anti-human CD3 conjugated with FITC, RPE and APC to perform autocompensation.

The DakoCytomation ER/PR pharmDx™ assay is an immunohistochemical (IHC) kit system to identify human estrogen receptor (ER) and human progesterone receptor (PR) expression in breast cancer tissues routinely processed and paraffin-embedded for histological evaluation. ER/PR pharmDx specifically detects the ER alpha protein as well as the PR located in the cell nucleus of ER and/or PR-expressing cells. ER/PR pharmDx is indicated as an aid in identifying patients eligible for treatment with antihormonal or aromatase inhibitor therapies, as well as an aid in the prognosis and management of breast cancer. The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is intended for laboratory use as a semi-quantitative detection of progesterone receptor by light microscopy in routinely processed normal and pathological human paraffinembedded tissue. This antibody is indicated for use as an aid in the management, prognosis and prediction of outcome of breast cancer. The clinical interpretation of any positive staining or its absence should be complemented by morphological and histological studies with proper controls. Evaluations should be made within the context of the patient's clinical history and other diagnostic tests by a qualified individual

The DakoCytomation ER/PR pharmDx™ assay is a semi-quantitative immunohistochemical (IHC) kit system to identify estrogen receptor (ER) and progesterone receptor (PR) expression in normal and neoplastic tissues routinely processed and paraffin-embedded for histological expressing cells respectively. ER/PR pharmDx assay is available in two configurations, both manual and automated and is optimized for use with DakoCytomation detection systems. The DakoCytomation Monoclonal Mouse Anti-Human Progesterone Receptor, clone PgR 1294, is a component of the ER/PR pharmDx kit, which will also be commercially available as a concentrate.