Applied Spectral Imaging received South Korean Ministry of Food and Drug Safety (MFDS) Clearance for GenASIs™ HiPath IHC Family for HER2, ER, PR and Ki67
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.”
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.
About SeongKohn Traders’ Corp.
SKT is specialized in the import and distribution of Histo/Cytopathology lab instruments, reagents, and consumables representing global pathology companies.
During the last 27 years, the company has contributed to the automation of the sample preparation and the introduction of liquid-based cytology and the renovation of autopsy suites in the local market.
SKT is also contributing to the facilitation of digital pathology solutions in addition to the conventional diagnostic practice and provides ‘digital slide web hosting service’ for the regular proficiency tests and slide conferences for the Korean Society of Pathologists (KSP) and the Korean Society for Cytopatholgists (KSC) and their sub-study groups and regional meetings, as well as other toxicology, dental, veterinary organizations. www.digitalpathology.co.kr
