Core Insights - BioNexus Gene Lab Corp. has entered into definitive agreements with Fidelion Diagnostics and Tongshu Biotechnology to commercialize the VitaGuard™ liquid-biopsy platform for minimal residual disease (MRD) testing [1][2][3] Strategic Highlights - The collaboration aims to support the development and commercialization of MRD testing in Southeast Asia, leveraging aligned ownership and operational support [2][3] - The goal is to replicate the cost reduction seen with the sub-$1,000 genome for MRD testing, making it more accessible [2][5] Transaction Details - BGLC will receive new shares from Fidelion equal to at least 15% of Fidelion's fully diluted share capital, while Fidelion will receive restricted BGLC shares equal to 19.9% of BGLC's pre-money outstanding shares [14] - The completion of the agreements is contingent upon an IP License Agreement granting BGLC exclusive commercialization rights across ASEAN [14] Clinical and Economic Impact - VitaGuard™ can detect circulating tumor DNA (ctDNA) down to 0.02% variant allele frequency at approximately 20,000× depth, recovering around 95% cfDNA [15] - The collaboration intends to broaden access to MRD testing in Southeast Asia, with an initial focus on Singapore and Malaysia [15] Next Steps - The parties expect to complete the agreements following the satisfaction of remaining conditions precedent within the specified period [6]

Core Insights - BioNexus Gene Lab Corp. (BGLC) and Fidelion Diagnostics have entered a strategic partnership aimed at enhancing liquid biopsy cancer monitoring and AI-driven biotechnology, marking a significant advancement in the field [1][2] Company Overview - BGLC will acquire a strategic equity stake in Fidelion and gain exclusive commercial rights to the VitaGuard™ platform for minimal-residual-disease (MRD) testing across Southeast Asia [2] - Fidelion will receive an equity investment and a licensing fee from BGLC, fostering long-term value creation for both companies [2] - The partnership is expected to leverage BGLC's commercial network to deliver next-generation cancer care to approximately 680 million people in Southeast Asia [7] Technology and Innovation - VitaGuard™ is a liquid biopsy technology that detects circulating tumor DNA (ctDNA) through a simple blood draw, offering earlier cancer recurrence detection compared to traditional methods [3][4] - The technology is tumor-naïve, meaning it can identify cancer without prior tumor sequencing, akin to facial recognition software [5] - VitaGuard™ significantly reduces the cost of MRD monitoring from over USD 3,000 to under USD 300, making it accessible to a broader market [6][4] Market Potential - Southeast Asia is projected to see over 2.4 million new cancer cases annually by 2030, indicating a substantial market opportunity for affordable cancer monitoring solutions [6] - The partnership aims to capitalize on the growing demand for cost-effective cancer diagnostics in the region [6] Strategic Highlights - VitaGuard™ technology achieves 0.02% variant-allele-frequency sensitivity and 95% cfDNA recovery, while maintaining sample stability for 14 days at room temperature [8] - BGLC will lead regulatory submissions and a phased rollout of the technology, starting in Singapore and Malaysia [8] - The partnership includes cross-shareholdings to ensure long-term strategic alignment between BGLC and Fidelion [8] Future Developments - The alliance plans to develop companion-diagnostic programs and an AI-powered Cancer Interception System utilizing longitudinal MRD datasets from VitaGuard™ [9]