iGeneTech Bioscience Co., Ltd.
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Anchored in clinical needs, we embark on the next decade

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    iGeneTech: Forging Ahead into the Second Decade with Clinical Needs at the Core

    Founded in 2014, iGeneTech officially stepped onto the threshold of its second decade in 2025.

    This year, our understanding of the industry has become clearer than ever:

    Molecular diagnostics and high-throughput sequencing (HTS) are evolving from "technically feasible" to "long-term usable, regulatable, and replicable."

    iGeneTech remains committed to consolidating its core foundational capabilities, poised for new breakthroughs.

    1. 2025: The "Shared Direction" of Policies and the Industry

    In 2025, policy signals surrounding clinical HTS have gradually clarified. A distinct trend is emerging: testing responsibility is shifting from "products" back to "laboratories and methodologies themselves."

    Against this backdrop, Laboratory Developed Tests (LDTs) are no longer merely "being liberalized"; instead, they require testing systems to possess long-term stable operational capabilities.

    This places more direct demands on upstream manufacturers:

    Probes and capture reagents are no longer simple consumables, but an integral part of testing methodologies.

    Consistency and reproducibility have replaced "one-time performance" as core metrics.

    Customization capabilities and response efficiency must align with real clinical rhythms.

    Based on this judgment, iGeneTech has continuously enhanced reagent stability over the past year, treating probe design, synthesis, and capture performance as long-term delivery capabilities rather than one-off project support.

     

    2. Oncology: Building Implementable Customization and Product Systems Centered on Real-World Clinical Needs

    In 2025, iGeneTech continues to focus on clinical needs in the medical field, prioritizing the promotion of its free MRD (Minimal Residual Disease) probe synthesis strategy and conducting in-depth collaborations with multiple corporate clients in oncology and immunology.

    In the field of custom oncology Panels, we have delivered over 300 high-quality custom Panel products to hundreds of clients, catering to diverse clinical testing scenarios.

    Leveraging a mature design system, stable synthesis and capture platforms, and extensive real-world project experience, we can efficiently respond to personalized needs across different testing objectives.

    Meanwhile, we have continuously expanded our predefined product portfolio, adding new solutions such as AIExome® V5 Oncology Edition, RNA Exome, Pan-Genomic HRD, AML MRD Panel, CpG Galaxy Panel, and Chimerism Detection. This achieves a dual-engine drive of custom Panels and predefined products.

     

    3. Immunology: Supporting Research and Translational Studies with Stable Data Capabilities

    In the field of immunosequencing, iGeneTech continues to deepen its presence in research applications. We not only offer BCR/TCR repertoire products based on multiplex amplicon technology but also have developed probe capture-based technical solutions:

    Cumulatively completed testing and analysis of over 1,200 HLA typing samples

    Cumulatively completed testing and analysis of over 2,000 immunosequencing samples

    We have always regarded data stability and interpretability as the core of our delivery, providing reliable technical support for disease mechanism research and target development.

     

    4. Genetics: Pushing Performance Metrics to the Limit, Refining Clinical Pathways for Greater Clarity

    In 2025, iGeneTech’s genetic testing product line underwent rapid continuous iteration:

    In March, AIExome® V5 Core Edition was launched, gaining widespread recognition both domestically and internationally for its exceptional uniformity performance of Fold80 1.24;

    In April, AIExome® Oncology Edition and AIExome® Genetic Edition were successively released;

    In the second half of the year, Clinical AIExome and Carrier Screening products were rolled out one after another;

    By the end of the year, the AIExome® "Flash Hybridization" Solution was introduced, targeting a 12-hour ultra-rapid testing cycle (from sample collection to report delivery) for critical care scenarios.

    The genetic product line now covers diverse research and clinical scenarios, continuously enhancing its technical advantages of high precision and flexibility.

     

    5. Methylation: Building a Multi-Species, Customizable Integrated Technology Platform

    Since the launch of its methylation technology platform, iGeneTech has developed a comprehensive solution covering double-stranded/single-stranded dual-track library construction and dual-platform capture (BisCap®/MethCap®).

    Centered on research scenarios such as CpG Island, CpG Galaxy, OmniTrait, and Mouse CpG Island, we provide one-stop semi-custom and full-custom services, which are widely applied in basic epigenetic research and tumor early screening & translational research.

     

    6. Quality Management System: Providing Solid Quality Assurance

    By the end of 2024, iGeneTech successfully completed the smooth relocation of its production facility from Jiaxing to Beijing. While reconstructing the management system and maintaining strict risk control, the company promoted the upgrading of its quality management. In 2025, iGeneTech successfully passed the certification audit for the GB/T 42061-2022 / ISO 13485:2016 Quality Management System (QMS), providing solid quality assurance for the company’s business compliance and large-scale development.

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    7. Toward the Next Decade: Four Defined Directions of Long-Termism

    At the threshold of its second decade, iGeneTech has reached a clearer consensus on its future development path.

    Technical & Data Metrics: Pushing Data Indicators to the Limit

    We will continue to invest in the most fundamental and irreplaceable capabilities:

    Lower Fold 80 values

    More stable uniformity

    More predictable capture efficiency

    Long-term adaptability to complex samples

    Our goal is not short-term performance, but stability and reliability over years of operation.

    Compliance & Quality Systems: Laying the Foundation for Long-Term Clinical Applications

    With the continuous improvement of regulatory frameworks, iGeneTech will further strengthen quality management, process traceability, and methodology validation capabilities. This ensures that our products and solutions can provide long-term support for standardized operations in clinical and LDT (Laboratory Developed Test) scenarios.

    Global Market Expansion: Aligning Technical Capabilities with International Demand

    Over the next decade, while consolidating its domestic foundation, iGeneTech will steadily expand its global market presence. Focusing on oncology, genetics, and epigenetics, we will pursue in-depth collaborations with overseas research institutions, clinical teams, and industrial partners.

    Brand Building: Evolving from a "Technology Supplier" to a "Trusted Technical Infrastructure"

    We aspire for iGeneTech to be recognized not merely as a product provider, but as a technical infrastructure that sustainably supports the operation of customers' testing systems—becoming a trusted long-term partner.

     


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