The platform has been developed 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.

ASI CEO Limor Shiposh said: "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."

ASI noted that the platform is an advanced image analysis platform for IHC and CISH samples that incorporates with existing lab microscopes and workflows, offering labs with a cost-effective solution for digital pathology.

The GenASIs platform has FDA approval for BandView Karyotyping, FISHView, SpotScan for CEP XY, UroVysion, ALK and HER2/neu FISH, and HiPath for IHC Family of HER2, ER, PR and Ki67.

ASI provides services to clinical laboratories, life science companies and research institutions in around 50 countries.