On 23^rd March, NGeneBio announced that it has applied to Korea Ministry of Food and Drug Safety (MFDS) for a class III in vitro diagnostic medical device of 'ONCOaccuPanel™', Comprehensive genomic profiling products based on NGS.

'ONCOaccuPanel™' is an NGS panel developed together with Seoul Asan Medical Center and Dana-Farber Cancer Institute. NGeneBio commercialized this panel via technology transfer and it can confirm clinical effectiveness by analyzing more than 100,000 clinical samples.

ONCOaccuPanel™ enables patients to receive personalized treatment by providing optimized targeting therapy information. This panel can detect MSI, TMB, and more than 300 genes that are related to 35 types of cancers such as lung, colon, gastric, and breast cancer. Besides, a dedicated software developed by NGeneBio, ‘NGeneAnalySys® helps to analyze large-scale genomic data accurately.

NGeneBio also noted that ONCOaccuPanel™ is under preparation for CE-IVD marking.