HLB Panagen Receives MFDS Approval for ROS1 Companion Diagnostic in Non-Small Cell Lung Cancer

HLB Panagen announced that its independently developed diagnostic product, ‘PANAMutyper™ ROS1,’ has been approved by the Ministry of Food and Drug Safety as a companion diagnostic product for Pfizer’s lung cancer targeted therapy ‘Xalkori (active ingredient: crizotinib).’

This is significant as it is the first time a domestic company has obtained approval for a companion diagnostic medical device targeting the ROS1 biomarker.

PANAMutyper™ ROS1 diagnoses the presence of the gene mutation biomarker 'ROS1' based on polymerase chain reaction (PCR). Typically, biomarker diagnostics for prescribing ROS1 inhibitors use next-generation sequencing (NGS) or PCR methods, with NGS taking about two weeks. PCR, on the other hand, completes testing within hours, allowing for rapid prescription of appropriate targeted anticancer drugs to patients.

PANAMutyper™ ROS1 is faster, completing tests within 3 hours, compared to the only other approved PCR-based ROS1 companion diagnostic device from China’s AmoyDx, and also offers improved user convenience, thus possessing sufficient market competitiveness.

Through companion diagnostic approval, HLB Panagen plans to strengthen its companion diagnostic portfolio for targeted therapies in non-small cell lung cancer such as EGFR, KRAS, and ROS1, aiming for synergistic effects. This will not only solidify its dominant position in the domestic cancer companion diagnostic market but also accelerate its global market expansion.

Jang In-geun, CEO of HLB Panagen, stated, "This approval is significant as it is the first companion diagnostic product approval for the ROS1 gene biomarker by a domestic company." He added, "Building on this milestone, we will strive to become an influential company leading the cancer companion diagnostic market not only in Korea but also globally."

This content was produced with the assistance of AI translation services.