FDA批准的精准医疗诊断体外器械一览表List of Cleared or Approved Companion Diagnostic Devices

Herceptin BLA 103792 INFORM HER-2/NEU P940004S001Ventana Medical Systems, Inc. (trastuzumab) The Inform Her-2/Neu gene detection system is a fluorescence in situ hybridization (FISH) DNA probe assay that determines the qualitative presence of Her-2/Neu gene amplification on formalin-fixed, paraffin embedded human breast tissue as an aid to stratify breast cancer patients according to risk for recurrence or disease-related death. It is indicated for use as an adjunct to existing clinical and pathologic information currently used as prognostic indicators in the risk stratification of breast cancer in patients who have had a priori invasive, localized breast carcinoma and who are lymph node-negative. HER2 CISH PharmDx kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Herceptin BLA 103792 HER2 CISH PharmDx Kit P100024S001-S005Dako Denmark A/S DakoAutostainer instruments. (trastuzumab) HER2 CISH pharmDx Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients. This kit is for in vitro diagnostic (IVD) use only. BLA 103792 PATHWAY ANTI-HER-2/NEU P990081S001-S028(4B5) Rabbit Monoclonal Primary Antibody Herceptin Ventana Medical Systems, Inc. Ventana Medical Systems’ PATHWAY Her2 (clone CB11) is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbB-2 antigen (trastuzumab) in sections of formalin-fixed, paraffin-embedded normal and neoplastic tissue on a Ventana automated immunohistochemistry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin treatment is being considered. BLA 103792 Bond Oracle Her2 IHC System P090015S001Herceptin Leica Biosystems (trastuzumab) The Bond Oracle Her2 IHC system is a semi-quantitative immunohistochemical (IHC) assay to determine Her2 (human epidermal growth factor receptor 2) oncoprotein status in formalin-fixed, paraffin-embedded breast cancer tissue processed for histological evaluation following automated staining on the bond-max slide staining instrument. The Bond Oracle Her2 IHC system is indicated as an aid in the assessment of patients for whom herceptin (trastuzumab) treatment is being considered. Herceptin BLA 103792 SPOT-LIGHT HER2 CISH Kit P050040S001-S003Life For In Vitro Diagnostic Use. Technologies, Inc. The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, (trastuzumab) paraffin-embedded (FFPE) breast carcinoma tissue sections using Chromogenic In Situ Hybridization (CISH) and brightfield microscopy. This test should be performed in a histopathology laboratory. The SPOT-Light HER2 CISH Kit is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. The assay results are intended for use as an adjunct to the clinicopathological information currently being used as part of the management of breast cancer patients. Interpretation of test results must be made within the context of the patient's clinical history by a qualified pathologist. BLA 103792 INSITE HER-2/NEU KIT P040030Herceptin Biogenex Laboratories, Inc. InSite Her-2/neu Mouse Monoclonal Antibody (Clone C1B11) kit is intended for In Vitro Diagnostic use in Immunohistochemistry (IHC) assays to semi-quantitatively localize by light