HLB Panagen Obtains Export Approval for RET and c-MET Mutation Diagnostic Products

HLB Panagen announced on the 27th that it has obtained export approval for two new molecular diagnostic products targeting gene mutations in non-small cell lung cancer: 'Rearranged during Transfection (RET)' and 'Hepatocyte Growth Factor Receptor (c-Met)'.

This year, following the approval of ‘Oncotector KRAS’ as a companion diagnostic medical device for the lung cancer drug ‘Lumakras’ and 'Panamutyper R EGFR' as the original companion diagnostic medical device for Yuhan Corporation’s ‘Reclaza’, the company plans to actively enter overseas markets by securing new products targeting additional mutations.

Currently, among non-small cell lung cancer treatments, Roche’s 'Gavreto' and Eli Lilly’s 'Retevmo' target RET, while Novartis’s 'Tabrecta' targets c-MET. The companion diagnostic devices for these products utilize next-generation sequencing (NGS) methods, which the company explains take more than two weeks for result analysis. In contrast, HLB Panagen’s molecular diagnostic device is based on artificial DNA (PNA), enabling rapid simultaneous detection of various mutations with very high sensitivity, allowing accurate mutation diagnosis within three hours using only a small amount of specimen, thus offering strong competitiveness.

Jang In-geun, CEO of HLB Panagen, stated, “Since joining CancerX, we have been expanding our product portfolio into various fields ranging from cancer diagnostics to infectious disease diagnostics to enter the U.S. market. We have already secured sales networks in the Middle East and Asia, and recently have been exploring market entry into South America, including Brazil, so soon diagnostic products from HLB Panagen will be available worldwide.”