Increasing Variant-Targeted Therapies... HLB Panajin Obtains Patent for Ultra-Low Variant Detection Diagnostic Technology

Molecular diagnostics company HLB Panagen announced on the 12th that it has obtained a domestic patent for a new technology that can stably detect ultra-low levels of target gene mutations. The company also stated that patent applications are underway overseas, including in the United States and Europe.

HLB Panagen explained that it succeeded in developing a new technology to detect gene mutations in the body more quickly and stably, based on a platform technology capable of mass-producing the world's only artificial gene, "Peptide Nucleic Acid (PNA)." The key to accurately detecting trace gene mutations is to amplify the target mutation while suppressing the amplification of normal genes. HLB Panagen's patented technology effectively implements both the amplification of gene mutations and the suppression of normal genes simultaneously, enabling precise detection without missing even the smallest gene mutations.

The company also stated that this technology has been applied to companion diagnostic (CDx) products that have already been approved. The patented technology is incorporated in "OncoTector KRAS," a companion diagnostic medical device approved earlier this year by the Ministry of Food and Drug Safety for Amgen's "Lumakras," a targeted therapy for non-small cell lung cancer (NSCLC) with KRAS mutations. Due to its high sensitivity and rapidly increasing demand in medical settings, HLB Panagen plans to gradually expand the patented new technology to other products to enhance its technological capabilities.

Companion diagnostics have recently gained attention as new anticancer drugs targeting specific gene mutations have emerged one after another. For these drugs to be effective, it is necessary to diagnose before administration whether the patient has the relevant mutation, and if so, how much of it is present, and then use the drug for selected patients. Yuhan Corporation’s "Reclaza," a non-small cell lung cancer treatment targeting epidermal growth factor receptor (EGFR) mutations, which recently expanded its indication as a first-line therapy, has led to HLB Panagen’s "PanaMutyper R EGFR" being approved by the Ministry of Food and Drug Safety as a ‘properly authorized companion diagnostic medical device’, with this approval also recorded in the product labeling.

Panagen's lung cancer diagnostic product 'Patamutyper R EGFR'. It is the first original companion diagnostic product in Korea, approved together with Yuhan Corporation's non-small cell lung cancer treatment 'Reclaza'.
[Photo by Panagen]

After joining the HLB Group last month and securing liquidity amounting to 80 billion KRW, HLB Panagen is also expanding its diagnostic business into the global market based on its high technological capabilities. Recently, it joined "CancerX," a cancer conquest consortium leading the U.S. government's cancer conquest project called the "Cancer Moonshot" project.

Jang In-geun, CEO of HLB Panagen, said, “Based on the original patented technology for PNA materials with excellent gene binding and stability, we have succeeded in developing various cancer diagnostic products such as ‘OncoTector’ and ‘PanaMutyper.’ We will continue to develop products for detecting trace gene mutations using the proprietary core technologies currently held by Panagen.”

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