Announcement • Jul 28
BioNexus Gene Lab Corp. Advances Commercialization of VitaGuard MRD Platform in Southeast Asia
BioNexus Gene Lab Corp. announced continued progress toward commercializing the VitaGuard molecular residual disease (MRD) platform in Southeast Asia following a recent working visit to facilities of the Tongshu Gene group in Shanghai and Changzhou, China, led by Dr. Muthu Meyyappan, Chief Commercial Officer of Fidelion Diagnostics Pte. Ltd. The visit combined technical planning with meetings at selected Chinese hospitals where VitaGuard is in paid commercial use. VitaGuard is a tumor-naive, fixed-panel liquid-biopsy platform that uses next-generation sequencing to look for circulating tumor DNA (ctDNA) associated with MRD in solid tumors. The system combines blood stabilization, cell-free DNA extraction, targeted sequencing, bioinformatics and reporting that can track molecular changes over time. Unlike patient-specific tests that first require a panel designed from tumor tissue, VitaGuard uses a fixed panel intended to make repeat blood-based monitoring simpler to deploy. For BioNexus, the platform offers a direct path into precision oncology in Southeast Asia and, through its investment in Fidelion, exposure to opportunities in other international markets. During the working sessions, the teams reviewed what will be needed to implement VitaGuard in Southeast Asia under the existing assignment and license agreements. They covered laboratory workflows, documentation, reagents and system requirements, local implementation and commercial coordination. The teams also discussed routes to market, including territorial licensing, laboratory partnerships, pharmaceutical collaborations and other strategic relationships. According to Tongshu Gene, VitaGuard is currently used on a paid commercial basis at numerous hospitals across China. Dr. Meyyappan and the Fidelion team visited selected sites and met physicians and laboratory personnel who use the platform. Their feedback was positive and gave the team a closer look at how VitaGuard fits into day-to-day workflows. These visits were not a formal clinical evaluation. VitaGuard grew out of the Tongshu Gene group's liquid-biopsy and molecular-diagnostics program. Tongshu Gene's work on the platform includes patent filings dating from at least 2018, proprietary reagents and panels, and clinical-research collaborations. In November 2025, Wuxi Tongshu Biotechnology Co., Limited, the contracting company within the Tongshu Gene group, assigned the VitaGuard intellectual-property rights outside the People's Republic of China to Fidelion. In the ten Southeast Asian markets specified in BioNexus' license, the Company's exclusive rights cover the use, development, manufacture, marketing, distribution and sale of VitaGuard-based products and services. BioNexus may also pursue local regulatory approvals and other commercial relationships in those markets and, with Fidelion's prior written consent as required under the license, grant sublicenses. BioNexus also owns approximately 15% of Fidelion. Together, the license and investment give BioNexus two paths to participate in VitaGuard's growth: directly through its Southeast Asian business and indirectly through Fidelion's licensing and partnerships elsewhere. BioNexus has previously said it expects VitaGuard's cost per test to be under USD 300, before local pricing, reimbursement and implementation considerations. If achieved, management believes this cost profile could make repeat molecular monitoring more accessible in cost-sensitive healthcare systems. MRD monitoring can involve testing at several points during and after treatment, creating the potential for repeat test volumes rather than a one-time diagnostic event. Together, BioNexus' ten licensed markets have a population of more than 680 million people, providing a large regional base as the Company pursues approved indications, clinical adoption and market access. Following the visit, BioNexus and Fidelion are advancing the transfer and localization of operating documentation, planning for local laboratory verification and validation, and regulatory and commercial preparation in Malaysia and Singapore. Subject to completion of this work and applicable approvals, BioNexus continues to target initial deployment in select Southeast Asian medical hubs during 2026. At the same time, Fidelion is engaged in discussions with prospective licensing, laboratory, pharmaceutical and commercial partners for markets outside Southeast Asia. No definitive agreement has been executed. Market entry will depend on completing the necessary laboratory, validation and regulatory work. Any future partnership will be subject to negotiation and definitive documentation, with material agreements disclosed as required.
