What Panagene Inc. does

Panagene Inc. (operating as HLB Panagene) is a South Korea-based precision molecular diagnostics company headquartered in Daejeon and listed on the Korean exchange (ticker 046210) as a subsidiary of HLB Group. The company is built around proprietary Peptide Nucleic Acid (PNA) technology, an artificial nucleic acid with a peptide-based backbone offering superior binding affinity, biological stability, and resistance to nuclease degradation compared to DNA/RNA. It operates multiple diagnostic platforms derived from this core technology: PANAMutyper (liquid biopsy mutation detection, including EGFR and ROS1 for lung cancer), PNAClamp (PCR clamping mutation detection), PANA RealTyper (multiplex real-time PCR for HPV, STI, and infectious diseases), and PANA qPCR (quantitative nucleic acid analysis). Through its 2024 acquisition of BioSquare, it added the QuantumPACK immunodiagnostics platform based on quantum dot nanoparticles for rapid point-of-care testing of RSV, Strep A, HIV, and other infectious diseases, supported by dedicated QDITS analyzers. The company also launched Korea's first Hyperion XTi spatial proteomics analysis service in December 2025 in partnership with Standard BioTools.

The business operates a B2B enterprise model serving hospitals, cancer centers, diagnostic laboratories, and pharmaceutical companies, distributing products directly in Korea and through international distributor networks across 59 countries. Revenue is generated through one-time sales of diagnostic kits and PNA materials (the company holds exclusive global commercial sales rights for PNA), hardware sales of QuantumPACK analyzers, companion diagnostic co-development deals with pharmaceutical partners (Pfizer for ROS1/Xalkori, Yuhan for EGFR/Leclaza, Elevar Therapeutics for FGFR2/Lirafugratinib), spatial proteomics services, and potential future licensing royalties from a new AOC therapeutic platform targeting Duchenne Muscular Dystrophy. The company has secured 93 regulatory approvals globally, including CE-IVDR, FDA, and MFDS clearances, and reported FY2024 revenue of KRW 13.2 billion (approximately USD 10 million) with 38.6% overseas sales, posting five consecutive quarters of operating profit through 2025-2026.

Name

Panagene Inc.

Legal name

PANAGENE Inc.

Website

https://panagene.com

Company type

Public

Founded year

2001

Operating status

Operating

Headcount range

51–100 employees

Short description

Panagene Inc. (HLB Panagene) is a South Korean precision molecular diagnostics company using proprietary Peptide Nucleic Acid (PNA) technology to deliver cancer mutation, infectious disease, and companion diagnostic kits to hospitals, laboratories, and pharmaceutical partners across 59 countries.

Ownership category

akta.pro rank

Product category

Molecular Diagnostics

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413), Medical Laboratories (621511), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Medical and Diagnostic Laboratories (62151)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071), Services-Commercial Physical & Biological Research (8731), Laboratory Analytical Instruments (3826)

akta.pro primary industry

Molecular Diagnostics (PCR/qPCR, NGS-based assays) (HLAAALAA)

akta.pro secondary industries

Molecular Diagnostics (PCR/NAAT/NGS-based IVD) (HLAHAAAD), Reagents, Chemicals & Assay Kits (Buffers, Antibodies, ELISA, Enzymes) (HLAGAIAI), Antibody Discovery & Engineering Platforms (display tech, bispecifics, Fc engineering) (HLAAAIAB), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Molecular diagnostics
• Companion diagnostics
• Cancer mutation detection
• Infectious disease testing
• PNA technology

Headquarters

HQ city

Daejeon

HQ country

South Korea

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain, Marketing or Sales

Revenue model

1. Molecular Diagnostics Products: Sales of PNA-based molecular diagnostic kits for oncology (EGFR, KRAS, NRAS, BRAF, ROS1, IDH1, IDH2, PIK3CA, TERT, EML4-ALK, BCR-ABL, JAK2, c-KIT) and infectious diseases (HPV, STD, CRE). Products include liquid biopsy and tissue biopsy tests, real-time PCR-based assays, and companion diagnostics.
2. PNA Materials and Custom Oligonucleotides: Commercial-scale production and sale of PNA oligos, gamma PNA, PNA FISH probes, and PNA monomers to research institutions and diagnostic companies. HLB Panagene has exclusive sales rights for PNA and is the sole provider for commercial use.
3. Immunodiagnostics (BioSquare Products): Sales of QuantumPACK-based immunodiagnostic products including RSV diagnostic kits (QuantumPACK Easy RSV Ag), HIV diagnostic kit (NanoPACK HIV 1/2 Ab), Strep A diagnostic kit (QuantumPACK Easy Strep A), and dedicated analyzers (QDITS Basic, QDITS Mini).
4. Spatial Proteomics Analysis Services: Offering spatial proteomics analysis services using Hyperion XTi Imaging System to academic institutions, industry partners, and research organizations. Part of strategy to become data platform company.
5. Companion Diagnostics Development: Joint development of Original Companion Diagnostics (CDx) with pharmaceutical partners. Revenue potential through simultaneous approval with new anticancer drugs, establishing standard benchmarks. Partnerships with Pfizer (ROS1 for Xalkori), Elevar Therapeutics (FGFR2 for Lirafugratinib), and Yuhan Corporation (EGFR for Leclaza).
6. AOC Therapeutic Platform Development: Developing Antibody-Oligonucleotide Conjugate (AOC) therapeutics using proprietary PNA as payload. Targeting Duchenne Muscular Dystrophy (DMD) as first indication. Future licensing potential for technology platform.

Go-to-market motion3 records

Distribution channels5 records

Marketing channels5 records

Core offering

HLB Panagene develops, manufactures, and sells PNA (Peptide Nucleic Acid)-based molecular diagnostic kits for cancer mutation detection (EGFR, KRAS, NRAS, BRAF, ROS1, IDH1/2, PIK3CA, TERT, EML4-ALK) and infectious diseases (HPV, STD, CRE, TB/NTM), as well as companion diagnostics co-developed with pharmaceutical partners. Through its subsidiary BioSquare, the company also sells quantum dot-based immunodiagnostic kits (RSV, HIV, Strep A) and dedicated analyzers for point-of-care testing.

Product overview

HLB Panagene is a precision molecular diagnostics company offering integrated diagnostic solutions centered on its proprietary PNA (Peptide Nucleic Acid) technology. The company operates three main technology platforms: PANA RealTyper (real-time PCR multiplex detection), PANAClamp (mutation detection), and PANAMutyper (liquid biopsy). Product portfolio spans oncology diagnostics (EGFR, KRAS, BRAF, ROS1, NRAS, IDH1/2, PIK3CA, TERT, EML4-ALK), infectious disease diagnostics (HPV, STD, CRE, TB/NTM), and PNA research products (Custom PNA Oligo, Gamma PNA, PNA FISH probes, PNA monomers). Through subsidiary BioSquare, the company offers immunodiagnostics using QuantumPACK quantum dot technology. The company is expanding into AI-powered multimodal diagnostics, spatial proteomics services (Hyperion XTi), and AOC therapeutics development using PNA as payload.

Differentiator

Problem solved

Functional benefit

Brands

• PANAMutyper: PNA-based mutation detection platform for cancer diagnostics including EGFR, ROS1 mutations
• PANA RealTyper
• PNAClamp
• PANA qPCR
• QuantumPACK

Products and services

• PANAMutyper Liquid Biopsy Platform Liquid biopsy-based assay platform for detecting cancer mutations with high sensitivity (0.1% mutant allele), including EGFR and ROS1 biomarkers for targeted therapy selection. Used by hospitals, cancer centers, and diagnostic laboratories.
• PANA RealTyper Real-time PCR Multiplex Detection Platform Real-time PCR-based multiplex detection platform for molecular diagnostics, including HPV genotyping and STD testing kits. CE-IVDR certified for European market.
• PNAClamp Mutation Detection Platform
• PANA qPCR Quantitative PCR Platform
• QuantumPACK Immunodiagnostic Platform BioSquare's proprietary quantum dot-based immunodiagnostic platform offering superior fluorescence signals, optical stability, and multiplex detection capabilities for point-of-care testing. Includes RSV, HIV, and Strep A diagnostic kits and dedicated analyzers.
• Custom PNA Oligo Synthesis
• Hyperion XTi Spatial Proteomics Analysis Service Spatial proteomics analysis service using the Hyperion XTi Imaging System (Standard BioTools) for precise identification of protein expression locations within cells and tissues. Provided to academic institutions, industry partners, and research organizations.
• QDITS Analyzer (Basic and Mini) Dedicated analyzers (QDITS Basic and QDITS Mini) for QuantumPACK immunodiagnostic products. FDA-registered for US market distribution.
• Companion Diagnostic Co-Development Services Joint development of Original Companion Diagnostics (CDx) with pharmaceutical partners for simultaneous approval with new anticancer drugs. Active partnerships with Pfizer (ROS1 for Xalkori), Elevar Therapeutics (FGFR2 for Lirafugratinib), and Yuhan Corporation (EGFR for Leclaza).

Quantifiable outcome

• Detects as little as 0.1% mutant allele fraction
• +4 more outcomes

Named customers5 records

Segments5 records

Ideal customer profiles3 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability6 records

Feature10 records

Partnerships

Seven partnerships are on record, tiered strategic and core.

• RocGene Technology LimitedstrategicChannel Partner/ Reseller/ Distributor · 27 January 2026Exclusive domestic distribution rights agreement for RocGene's point-of-care testing (POCT) product lineup in Korea. HLB Panagene will supply molecular diagnostic instruments and research-use solutions to hospitals, diagnostic laboratories, and testing facilities. Future OEM product development using RocGene's instruments and cartridge platforms being reviewed.
• Standard BioToolsstrategicTechnology or Integration · 11 December 2025Acquisition of Hyperion XTi Imaging System for spatial proteomics analysis services. Standard BioTools is a global leader in single-cell spatial proteomics market. HLB Panagene became first in Korea to provide services utilizing this next-generation Imaging Mass Cytometry model.
• ArontiercoreTechnology or Integration · 1 June 2025Strategic investment and joint research partnership with AI-based drug discovery company. HLB Panagene invested approximately KRW 5 billion in Arontier to develop AI-powered multimodal diagnostic platform integrating genomic, proteomic, and imaging data. Collaboration aims to develop Virtual Staining and Digital Twin technology for predicting protein distributions from standard H&E-stained slides.
• Yuhan CorporationcoreStrategic or Co-development Partner · 25 April 2025PANA Mutyper EGFR companion diagnostic for Leclaza (Lazertinib) lung cancer treatment - Korea's first Original Companion Diagnostic approved by MFDS.
• Elevar TherapeuticscoreStrategic or Co-development Partner · 24 April 2025Joint development of Original Companion Diagnostic (CDx) device for Lirafugratinib, an FGFR2-targeted therapy for urothelial cancer. This marks first tangible achievement of business synergy between HLB Group's drug development and diagnostics affiliates, and represents HLB Panagene's entry into US market.
• PfizercoreStrategic or Co-development Partner · 2 April 2025Companion diagnostic partnership for Xalkori (Crizotinib) targeted lung cancer therapy. HLB Panagene's PANA Mutyper ROS1 became Korea's first MFDS-approved ROS1 companion diagnostic for this therapy.
• BioSquarecoreStrategic or Co-development Partner · 1 January 2024Acquisition of immunodiagnostics company BioSquare in 2024, adding QuantumPACK immunodiagnostic platform capabilities. BioSquare brings point-of-care testing products with FDA registrations and proprietary quantum dot-based technology. Products now marketed jointly with HLB Panagene.

Scale indicators8 records

Recent moves5 records

Expansion highlights7 records

Broad incumbents

• Bio-Rad Laboratories: Large life-science tools and clinical diagnostics company with droplet-digital PCR (ddPCR) and qPCR-based oncology mutation detection products. Comparable platform technology to Panagene's PNA-based PCR clamping approaches.
• QIAGEN: Global IVD and molecular diagnostics leader with broad oncology mutation detection menu and companion diagnostic partnerships across pharma. Highly comparable to Panagene's PNA-based molecular diagnostic franchise and CDx strategy.
• bioMérieux: French in-vitro diagnostics leader with broad microbiology, infectious disease, and oncology IVD portfolio and strong IVDR roll-out. Comparable to Panagene's IVDR strategy and infectious disease menu (HPV, STD, CRE).
• Sysmex Corporation: Japanese in-vitro diagnostics leader with IVDR-certified oncology and infectious disease assays across Asia and Europe. Directly comparable to Panagene's IVD product portfolio and IVDR strategy.

Emerging players

• Burning Rock Biotech: China-based molecular diagnostics company focused on NGS-based oncology testing and companion diagnostics. Comparable Asian-market CDx player with similar pharma partnership model.
• Standard BioTools: US-based spatial proteomics / imaging mass cytometry (Hyperion XTi) platform provider. A partner of Panagene but also a peer in the emerging spatial omics services market where Panagene is competing as a Korea-based service provider.

Direct peers

• Seegene Inc. Korean molecular diagnostics company developing PCR-based multiplex assays for infectious diseases (HPV, STI, respiratory) and oncology. Closest geographical and product-line peer to Panagene, including HPV and STD testing overlap.
• Asuragen (a Hologic company): Specialized molecular diagnostics developer focused on oncology mutation detection reagents, including qPCR-based kits with high sensitivity similar to Panagene's PANA platforms. Direct overlap in somatic mutation detection for cancer.
• Gencurix Inc. Korean molecular diagnostics company specializing in cancer mutation detection kits and biomarker assays for lung, colorectal, and breast cancer. Direct overlap with Panagene's KRAS, EGFR, BRAF, PIK3CA diagnostic products.
• NeoGenomics Laboratories: US-based oncology-focused clinical laboratory offering molecular diagnostics and CDx services, including NGS and PCR-based mutation panels. Comparable in oncology companion diagnostics positioning and pharma partnerships.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Panagene Inc.