Applied Spectral Imaging receives FDA Clearance for GenASIs™ HiPath IHC Family for HER2, ER, PR and Ki67
Carlsbad, CA. – January 21, 2015 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced that it 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 IHC and CISH samples that integrates with existing lab microscopes and workflows, providing labs with a cost-effective solution for digital pathology. The platform is intended for use 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 superior 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 extensive 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,” said Limor Shiposh, CEO of ASI.
“Our GenASIs solutions and robust portfolio of FDA cleared applications assist our customers in improving workflow and achieving more accurate clinical results, more efficiently and cost effectively.”
About ASI
ASI is a global leader in the development of 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. 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, to best suit the needs, size and budget of any lab.
The GenASIs platform 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 serves clinical laboratories, life science companies and research institutions in over 50 countries, through direct sales and service personnel and its extensive worldwide distribution partners.
Source: Applied Spectral Imaging
