05.07.15
Applied Spectral Imaging Ltd. (ASI) has received clearance from the U.S. Food and Drug Administration (FDA) for its GenASIs HiPath image capture and analysis platform.
ASI’s GenASIs HiPath IHC family is an advanced image analysis platform for immunohistochemistry (IHC) and chromogenic in situhybridization (CISH) samples that integrates with existing lab microscopes and workflows, providing labs with a cost-effective solution for digital pathology, the company claims. The platform is designed as an aid to pathologists in the quantitative analysis and scoring of HER2, Estrogen Receptor (ER) (SP1), Progesterone Receptor (PR) and Ki67 (30-9) proteins in formalin-fixed, paraffin-embedded breast cancer tissue.
“The FDA clearance represents ASI’s commitment in offering diagnostics tools to assist pathologists with their quantitative analysis. With the GenASIs HiPath, ASI is proud to offer pathologists an important, easy to use solution to improve workflow and obtain reliable clinical results. It is a valuable addition to our portfolio of FDA- cleared computerized clinical diagnostic aids covering both brightfield IHC and FISH probes. Pathologists can now capture with one click the relevant tumor regions, using their own microscope and receive immediate scoring and statistical analysis of the selected region of interest,” CEO Limor Shiposh said. “Our GenASIs solutions and portfolio of FDA-cleared applications assist our customers in improving workflow and achieving more accurate clinical results, more efficiently and cost effectively.”
Based in Carlsbad, Calif., ASI develops imaging solutions for pathology, cytogenetic, and life science research.
The GenASIs automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and reliable results. The GenASIs platform can be used with any brand of brightfield or fluorescence microscope, and supports manual and automatic scanning for a wide range of workflows and applications; the product is FDA-cleared for BandView Karyotyping, FISHView, SpotScan for CEP XY, UroVysion, ALK and HER2/neu FISH, and HiPath for IHC Family: HER2, ER, PR and Ki67.
ASI’s GenASIs HiPath IHC family is an advanced image analysis platform for immunohistochemistry (IHC) and chromogenic in situhybridization (CISH) samples that integrates with existing lab microscopes and workflows, providing labs with a cost-effective solution for digital pathology, the company claims. The platform is designed as an aid to pathologists in the quantitative analysis and scoring of HER2, Estrogen Receptor (ER) (SP1), Progesterone Receptor (PR) and Ki67 (30-9) proteins in formalin-fixed, paraffin-embedded breast cancer tissue.
“The FDA clearance represents ASI’s commitment in offering diagnostics tools to assist pathologists with their quantitative analysis. With the GenASIs HiPath, ASI is proud to offer pathologists an important, easy to use solution to improve workflow and obtain reliable clinical results. It is a valuable addition to our portfolio of FDA- cleared computerized clinical diagnostic aids covering both brightfield IHC and FISH probes. Pathologists can now capture with one click the relevant tumor regions, using their own microscope and receive immediate scoring and statistical analysis of the selected region of interest,” CEO Limor Shiposh said. “Our GenASIs solutions and portfolio of FDA-cleared applications assist our customers in improving workflow and achieving more accurate clinical results, more efficiently and cost effectively.”
Based in Carlsbad, Calif., ASI develops imaging solutions for pathology, cytogenetic, and life science research.
The GenASIs automated imaging platforms for pathology and genetic analysis provide advanced diagnostic aids for pathologists and cytogeneticists, with reproducible and reliable results. The GenASIs platform can be used with any brand of brightfield or fluorescence microscope, and supports manual and automatic scanning for a wide range of workflows and applications; the product is FDA-cleared for BandView Karyotyping, FISHView, SpotScan for CEP XY, UroVysion, ALK and HER2/neu FISH, and HiPath for IHC Family: HER2, ER, PR and Ki67.