PharmDx Solution is a portfolio of all-in-one pharmDx kits that lead to optimal diagnostic results within companion diagnostics. Correct results the first time help select the right therapy for each patient – every time. PharmDx is all about personalized medicine meaning making a difference to the assessment of patient treatment. The validated kits have the right specificity and sensitivity. Correct results the first time lead to fewer reruns and will help select the right therapy for each patient every time. The kits help improve patient care by delivering fast results with great confidence and reducing time from biopsy to diagnosis.
HercepTest is a semi-quantitative immunohistochemical assay for determination of HER2 protein (c-erbB-2 oncoprotein) overexpression in breast cancer tissues routinely processed for histological evaluation and formalin-fixed, paraffin-embedded cancer tissue from patients with adenocarcinoma of the stomach, including the gastroesophageal junction. HercepTest specifically demonstrates overexpression of HER2 protein.
The human HER2 gene with the generic name ERBB2 (also known as NEU) encodes the HER2 protein or p185HER2. The HER2 protein is a membrane receptor tyrosine kinase with homology to the epidermal growth factor receptor (EGFR). The HER2 gene is a normal component present in two copies in all normal diploid cells. In a fraction of patients (15-20%) with breast cancer, the HER2 gene is amplified as a part of the process of malignant transformation and tumor progression. HER2 gene amplification leads to overexpression of the HER2 protein on the surface of breast cancer cells. HER2 gene amplification and receptor prevalence correlates with poor breast cancer prognosis, including relapse-free and overall survival. HER2 IQFISH pharmDx is the latest Dako HER2 diagnostic kit indicated as an aid in the assessment of patients for whom Herceptin™ treatment is considered.
HER2 CISH pharmDx Kit is a dual color chromogenic assay designed to quantitatively determine HER2 gene amplifications in formalin-fixed, paraffin-embedded breast cancer tissue specimens using bright field microscopy. Gene amplification is determined from the ratio between the number of signals from the visualization of the HER2 gene probe (red signals) and the number of signals from the reference chromosome 17 probe (blue signals). HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin™ treatment is being considered. Results are intended for use as an adjunct to the information currently used for estimating prognosis in stage II, node-positive breast cancer patients. Chromogenic dual color visualization allows fast and convenient method for scoring with easy identification of invasive tissue and internal control.
Advancing Immunotherapy Options
PD-L1 IHC 28-8 pharmDx is a qualitative immunohistochemical assay using Monoclonal Rabbit Anti-PD-L1, Clone 28-8 intended for use in the detection of PD-L1 protein in formalin-fixed paraffin-embedded (FFPE) non-squamous non-small cell lung cancer (NSCLC), squamous cell carcinoma of the head and neck (SCCHN) and melanoma tissues using EnVision FLEX visualization system on Autostainer Link 48.
Advancing Immunotherapy Options
PD-L1 IHC 22C3 pharmDx is a qualitative immunohistochemical assay using Monoclonal Mouse Anti-PD-L1, Clone 22C3 intended for use in the detection of PD-L1 protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) and melanoma tissue using EnVision FLEX visualization system on Autostainer Link 48.
FΠλήρεFς ΚΙΤ που διαθέτει όλα τα απαραίτητα αντιδραστήρια καθώς και θετικούς μάρτυρες για το διαγνωστικό έλεγχο των αντιγόνων οιστρογόνου (ER) και προγεστερόνης (PR). Διαθέτει έγκριση από το διεθνή οργανισμό FDA.
Epidermal growth factor receptor (EGFR) is a transmembrane receptor encoded by the human HER1 gene. EGFR is a member of the EGF/erbB receptor family of related growth factor receptors, which include HER2/erbB2 or neu, HER3/erbB3, and HER4/erbB4. The EGFR protein is expressed by a variety of normal cells and is thought to play an important role in the regulation of cell division and tumor growth. EGFR overexpression has been demonstrated in a variety of neoplasms.