Legal & regulatory
Clarity begins with present reality
and clear boundaries around what comes next
Important context for the product, science, corporate information and future-looking statements on this website.
Product status
Laboratory delivered. Not for general sale.
VitaGuard originated as a commercially used laboratory-developed test (LDT) workflow. Fidelion's intended model is delivery through qualified laboratories, not sale as an over-the-counter product, test kit for general sale or direct-to-consumer service.
International VitaGuard rights outside Mainland China, Hong Kong, Macau and Taiwan have been assigned to Fidelion. That legal assignment is complete; operational implementation, laboratory transfer, quality work and validation for new settings remain in progress.
VitaGuard is not currently offered by Fidelion for general sale. Availability through Fidelion in any jurisdiction depends on the relevant laboratory, intended use, validation, quality system and applicable legal or regulatory requirements. References to potential benefits describe intended or possible uses that require appropriate evidence; they are not promises of clinical outcome.
Scientific information
Evidence has boundaries.
Scientific content is provided for corporate and educational information. Study results apply to the populations, panels, workflows and endpoints studied. Not every publication discussed on this site used or independently validated the complete current VitaGuard configuration.
Earlier molecular detection does not by itself establish that testing improves treatment decisions or patient outcomes. VitaGuard is not a substitute for imaging, pathology, clinical judgment or other established follow-up. Nothing on this website is medical advice or a diagnosis or treatment recommendation.
Corporate relationships
Fidelion and BioNexus are separate companies.
Fidelion Diagnostics Pte. Ltd. is a privately held Singapore company. BioNexus Gene Lab Corp. is a separate publicly traded company. Under agreements announced in December 2025, BioNexus became a minority shareholder in Fidelion and Fidelion granted BioNexus an exclusive VitaGuard licence for Southeast Asia.
Ownership of securities in BioNexus does not constitute ownership of securities in Fidelion. Each company has its own board, obligations, financial position and disclosure responsibilities. Readers should rely on each company's own approved disclosures when evaluating it.
Read the BioNexus public filing ↗
Securities information
No offer or solicitation.
Fidelion is privately held. Nothing on this website constitutes or forms part of an offer to sell, an invitation to offer, or a solicitation to buy any security in Fidelion, BioNexus or any other entity. No securities offering or public listing is being presented through this website, and the information is not investment, financial, legal or tax advice.
Forward-looking statements
Ambition is not present capability.
This website includes statements about possible future validation, laboratory implementation, partnerships, market access, research, software, data and AI-assisted applications. These statements describe plans, aims or possibilities and are not guarantees.
Outcomes may differ because of scientific and analytical performance, reproducibility, product-definition and technology-transfer work, regulatory and quality requirements, access to data and appropriate consent, privacy and cybersecurity obligations, partner performance, market adoption, competition, financing, intellectual-property matters and execution risk. Fidelion undertakes no obligation to update forward-looking statements except where required by law.
Data & AI status
A research direction, not a clinical product.
No Fidelion AI product is currently available for clinical use. Any future application would require an appropriate legal basis for data use, robust governance, validation, clinical evidence and regulatory review where applicable.