HLB PANAGENE's independently developed companion diagnostic product has been approved as the first companion diagnostic medical device in South Korea for the non-small cell lung cancer gene mutation ROS1.
On the 5th, HLB PANAGENE said that the "PANAMutyper™ ROS1" has received item approval from the Ministry of Food and Drug Safety as a companion diagnostic product for Pfizer's lung cancer targeted therapy "Xalkori (ingredient name crizotinib)."
30 to 40% of lung cancer patients have gene mutations. So far, eight types of lung cancer gene mutations have been identified, including epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS1, and KRAS.
The PANAMutyper ROS1 diagnoses whether there is a ROS1 mutation based on polymerase chain reaction (PCR). Patients who test positive for the ROS1 gene are prescribed ROS1 inhibitors for treatment. To prescribe, diagnosis is conducted using next-generation sequencing (NGS) and PCR methods, where NGS can take up to two weeks to complete, while PCR finishes within hours. PCR is more efficient for quickly prescribing suitable targeted anticancer agents to patients.
HLB PANAGENE explained that the PANAMutyper ROS1 performs tests faster than the existing only approved companion diagnostic product, AmoyDx's PCR-based ROS1, which takes within three hours, and has improved user convenience, thus ensuring sufficient market competitiveness. With this approval, the company plans to strengthen its product line for companion diagnostics related to non-small cell lung cancer targeted therapies such as EGFR, KRAS, and ROS1.
The company plans to accelerate its pursuit of the global market. According to the global market research firm Grand View Research, the global cancer companion diagnostic market is expected to grow annually by about 8.7% from approximately 7 trillion won in 2023. Currently, lung cancer, which has a high number of patients, is leading the companion diagnostic market, accounting for about 30.3% of the total market as of 2023.
Jang In-gun, CEO of HLB PANAGENE, noted, "This approval is significant as it marks the first item approval for the ROS1 gene biomarker companion diagnostics by a domestic corporation," adding, "We will strive to become an influential corporation leading the cancer companion diagnostic market not only in Korea but also globally from this point forward."