Ministry of Food and Drug Safety (MFDS) Clearance for GenASIs HiPath IHC Family

CARLSBAD, Calif. - April 16, 2015 - PRLog -- Carlsbad, CA. – April 16, 2015 – Applied Spectral Imaging (ASI, www.spectral-imaging.com) announced today that it has received clearance from the South Korean Ministry of Food and Drug Safety (MFDS) for its GenASIs HiPath image capture and analysis platform. The South Korean market is a key market for ASI’s computer-aided imaging solutions for pathology, which help improve patient care. “We are looking forward to leveraging this important clearance to offer our advanced image capture and analysis platform to the Korean population”, said Limor Shiposh, ASI’s Chief Executive Officer.

ASI’s GenASIs HiPath IHC Family is an advanced image analysis platform for IHC 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 semi-quantitative analysis and scoring of HER2, and qualitative analysis and scoring of Estrogen Receptor (ER) (SP1), Progesterone Receptor (PR) and Ki67 (30-9) proteins in formalin-fixed, paraffin-embedded breast cancer tissue.

“The South Korean market is a rapidly-growing market, and with the GenASIs HiPath, pathologists in South Korean’s hospitals and laboratories will now be able to use their own microscope and capture the relevant tumor regions with just one click, receiving immediate scoring and statistical analysis of the selected region of interest,” said Limor Shiposh, ASI’s Chief Executive Officer. “This clearance is the result of months of work and it is a valuable addition to our worldwide clearances portfolio for computerized clinical diagnostic aids covering both brightfield IHC and FISH probes”, Mrs. Shiposh added.

“The GenASIs HiPath is a superior diagnostic tool which assists pathologists with their analysis”, said Mr. Moo Yeol Yoon, President of SeongKohn Traders' Corp., ASI’s distributor for the GenASIs HiPath in South Korea. “We are confident that the Korean market will be eager to take advantage of this advanced imaging option and we are excited to facilitate that process. The ASI GenASIs HiPath provides an unprecedented diagnostic practice for the local pathologists, which will advance patient care and assist our customers in improving workflow and achieving more accurate clinical results, efficiently and cost effectively.”