[Seok Jihoen, Edaliy Reporter] “We are targeting double-digit sales growth this year. In February, we received Korea’s first regulatory approval for a companion diagnostic device for ROS1 mutations in non-small cell lung cancer, opening a new market. Our new overseas markets are also showing clear growth momentum,” said Jang In-keun, CEO of HLB Panagene, in a recent interview with Edaily.
Expanding Diagnostic Reach With Proprietary PNA Technology
HLB Panagene developed the world’s first mass production technology for PNA (peptide nucleic acid), a synthetic nucleic acid material known for its high binding affinity, sequence specificity, and stability compared to conventional DNA or RNA.
“Having proprietary core materials that can be widely applied in diagnostics is a major advantage,” Jang said. “We’ve internally developed extraction devices, enabling us to cover the full spectrum from materials to bio and precision manufacturing.”
The company has evolved its diagnostic platform through three generations based on the strong binding and selectivity of PNA. The first-generation PNAClamp focused on high-accuracy mutation detection through selective gene amplification. The second-generation PANAMutyper enabled multiplex detection and liquid biopsy with enhanced sensitivity. The latest, third-generation OncoTector combines the broad device compatibility of the first generation with the liquid biopsy capability of the second.
HLB Panagene’s strength is reflected in its market share in cancer diagnostics. It commands 90% of Korea’s market for EGFR mutation testing, 80% for KRAS/NRAS, and 60% for BRAF mutations in lung cancer. In February, its PANAMutyper ROS1 test received approval from Korea’s Ministry of Food and Drug Safety as a companion diagnostic for Pfizer’s lung cancer drug Xalkori. In 2023, its PANAMutyper EGFR test was approved as the original companion diagnostic for Yuhan’s lung cancer treatment Lekraza.
The company plans to expand further into infectious diseases and respiratory diagnostics this year to build more stable, recurring revenue in molecular diagnostics. “We’re upgrading our HPV, STD, and CRE test technologies and accelerating development of respiratory virus (RV), respiratory bacteria (RB), and gastrointestinal infection (GI) panels,” Jang said.
Goal: 50% of Revenue From Overseas Within 3 Years
HLB Panagene expects continued revenue growth with broader global expansion. The company entered four new markets, including Malaysia, and anticipates its first revenues from Latin America this year. While it already distributes its diagnostics in 28 countries, it aims to continue adding new markets.
HLB Panagene posted 13.2 billion won in revenue last year, with overseas sales accounting for 5.1 billion won, or 38.6% of the total. The company aims to raise that share to 50% within the next three years and expects to begin generating revenue from the Latin American market starting this year.
The company is also identifying AI and immunodiagnostics as new growth engines. “Although our current portfolio focuses on molecular diagnostics, we plan to expand into AI-powered and point-of-care immunodiagnostic products to respond to future market trends,” Jang said.
To that end, HLB Panagene acquired immunodiagnostics firm BioSquare and invested in AI drug discovery company Arontier. “The diagnostics market is evolving toward integrated ‘multimodal’ systems. Our goal is to go beyond molecular testing and build a comprehensive diagnostic platform,” he added.
Jang, a scientist-turned-executive, has led HLB’s bio business since 2013 and took the helm of HLB Panagene in August 2023. HLB acquired Panagene through its consortium of five affiliates in June 2023.
“After a thorough post-merger integration process, we’ve completed internal restructuring and strategic planning and are now executing the next phase,” Jang said. “We want to be remembered as a company that delivers precise diagnoses through integrated, multimodal platforms.”
He added, “HLB Panagene is a technology-driven growth company. We won’t be swayed by trends but will focus on the fundamentals of diagnostics to emerge as a global total solution diagnostic platform provider.”
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HLB Panagene developed the world’s first mass production technology for PNA (peptide nucleic acid), a synthetic nucleic acid material known for its high binding affinity, sequence specificity, and stability compared to conventional DNA or RNA.
“Having proprietary core materials that can be widely applied in diagnostics is a major advantage,” Jang said. “We’ve internally developed extraction devices, enabling us to cover the full spectrum from materials to bio and precision manufacturing.”
The company has evolved its diagnostic platform through three generations based on the strong binding and selectivity of PNA. The first-generation PNAClamp focused on high-accuracy mutation detection through selective gene amplification. The second-generation PANAMutyper enabled multiplex detection and liquid biopsy with enhanced sensitivity. The latest, third-generation OncoTector combines the broad device compatibility of the first generation with the liquid biopsy capability of the second.
HLB Panagene’s strength is reflected in its market share in cancer diagnostics. It commands 90% of Korea’s market for EGFR mutation testing, 80% for KRAS/NRAS, and 60% for BRAF mutations in lung cancer. In February, its PANAMutyper ROS1 test received approval from Korea’s Ministry of Food and Drug Safety as a companion diagnostic for Pfizer’s lung cancer drug Xalkori. In 2023, its PANAMutyper EGFR test was approved as the original companion diagnostic for Yuhan’s lung cancer treatment Lekraza.
The company plans to expand further into infectious diseases and respiratory diagnostics this year to build more stable, recurring revenue in molecular diagnostics. “We’re upgrading our HPV, STD, and CRE test technologies and accelerating development of respiratory virus (RV), respiratory bacteria (RB), and gastrointestinal infection (GI) panels,” Jang said.
Goal: 50% of Revenue From Overseas Within 3 Years
HLB Panagene expects continued revenue growth with broader global expansion. The company entered four new markets, including Malaysia, and anticipates its first revenues from Latin America this year. While it already distributes its diagnostics in 28 countries, it aims to continue adding new markets.
HLB Panagene posted 13.2 billion won in revenue last year, with overseas sales accounting for 5.1 billion won, or 38.6% of the total. The company aims to raise that share to 50% within the next three years and expects to begin generating revenue from the Latin American market starting this year.
The company is also identifying AI and immunodiagnostics as new growth engines. “Although our current portfolio focuses on molecular diagnostics, we plan to expand into AI-powered and point-of-care immunodiagnostic products to respond to future market trends,” Jang said.
To that end, HLB Panagene acquired immunodiagnostics firm BioSquare and invested in AI drug discovery company Arontier. “The diagnostics market is evolving toward integrated ‘multimodal’ systems. Our goal is to go beyond molecular testing and build a comprehensive diagnostic platform,” he added.
Jang, a scientist-turned-executive, has led HLB’s bio business since 2013 and took the helm of HLB Panagene in August 2023. HLB acquired Panagene through its consortium of five affiliates in June 2023.
“After a thorough post-merger integration process, we’ve completed internal restructuring and strategic planning and are now executing the next phase,” Jang said. “We want to be remembered as a company that delivers precise diagnoses through integrated, multimodal platforms.”
He added, “HLB Panagene is a technology-driven growth company. We won’t be swayed by trends but will focus on the fundamentals of diagnostics to emerge as a global total solution diagnostic platform provider.”
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