Tongshu Gene
Original developmentDeveloped the VitaGuard technology and associated laboratory workflow in China.
VitaGuard™ MRD
Commercialized in China.
Preparing for ASEAN.
The VitaGuard technology has been commercialized as a laboratory-developed test in China. ASEAN deployment remains subject to local technical validation, regulatory requirements, laboratory implementation and commercial execution.
VitaGuard is not currently approved or generally available as an ASEAN clinical service. BGLC is advancing the technical validation, regulatory work, laboratory implementation and commercial preparation required for potential regional deployment. Molecular residual-disease monitoring is not a substitute for professional medical advice, diagnosis, treatment or established clinical follow-up. Performance and permitted use depend on the specific workflow, indication and jurisdiction.
Statements on this page about plans, expectations and future events are forward-looking statements that involve risks and uncertainties, and actual results may differ materially. See the forward-looking statements notice and the risk factors in BGLC's SEC filings.
The VitaGuard relationship
A contractual chain of rights.
A separate regional implementation.
Fidelion holds the contractual and intellectual-property rights supporting international development and commercialization outside the retained Greater China territory, subject to the applicable agreements. BGLC's rights in ASEAN arise from the executed November 2025 license.
Fidelion Diagnostics
Contractual platform rightsHolds rights supporting international development and commercialization outside the retained Greater China territory, subject to the applicable agreements.
BioNexus Gene Lab
Exclusive regional licenseeHolds an exclusive, perpetual and irrevocable license within the defined Southeast Asia territory, subject to the filed agreement.
The practical starting point
Begin with blood.
Not a patient-specific tumor assay.
After cancer treatment, small amounts of tumor-derived material may remain below the resolution of conventional imaging. MRD testing looks for molecular signals in circulating tumor DNA that may help assess residual disease and change over time.
BGLC's November 12, 2025 filed release (opens in a new tab) described VitaGuard as tumor-naive and requiring no tumor-tissue sample. A fixed-panel approach is intended to begin from blood without first building a patient-specific assay from tumor tissue. This design description is not a claim of clinical performance.
The molecular signal
cfDNA is the pool.
ctDNA is the tumor-derived fraction.
Cell-free DNA, or cfDNA, consists of small DNA fragments released into the bloodstream as cells turn over. Most cfDNA is not cancer-derived.
Circulating tumor DNA, or ctDNA, is the smaller fraction shed by tumor cells. Detecting low-frequency candidate signals requires careful control across collection, processing, sequencing and interpretation.
Molecular materialCell-free DNA
Signal of interestCirculating tumor DNA
Workflow descriptionTumor-naive
Workflow description
From blood collection to repeat molecular reporting.
The stages below describe the intended workflow architecture. They do not establish regulatory authorization or clinical performance.
- 01Blood collection and stabilization
A blood sample is collected for downstream cell-free DNA processing.
- 02cfDNA extraction
Plasma cell-free DNA is isolated as input for library preparation.
- 03Molecular tagging
Unique molecular identifiers are used to help track source molecules.
- 04Targeted sequencing
Selected genomic regions are sequenced to evaluate candidate signals.
- 05Error suppression and interpretation
Computational processing evaluates molecular evidence and potential technical error.
- 06Longitudinal reporting
Repeat results may be organized for clinical review across time points.
Design attributes
Features intended to support a repeat blood-based workflow.
The platform is described as beginning from blood without first building an assay from an individual's tumor tissue.
Pre-analytical handling is part of the complete workflow and requires locally verified procedures.
Molecular identifiers are intended to help distinguish candidate signals from technical error.
Repeat blood draws may support comparison over time when clinically and legally appropriate.
Historical technical statement
Reported technical profile.
The company's November 12, 2025 filed release reported that VitaGuard had shown detection down to 0.02% variant allele frequency at approximately 20,000× sequencing depth and approximately 95% cfDNA recovery. Those figures are historical development statements from that release—not universal clinical outcomes, a formal regulatory limit of detection, or evidence of ASEAN authorization.
Read the dated filed release (opens in a new tab)The filed figures do not establish patient-level performance across cancers, stages or intended-use populations.
Local technical, regulatory, laboratory and commercial requirements remain.
ASEAN implementation
Validate locally. Meet requirements. Establish operations.
The filed license permits defined regional activities subject to its terms. It does not itself constitute a regulatory authorization or make the platform clinically available in an ASEAN market.
Potential deployment requires local technical validation, quality controls, laboratory implementation, regulatory requirements and commercial execution. Availability and permitted use will depend on each market and indication.
Review the filed license (opens in a new tab)Progress to date
What has happened in 2026, as filed.
VitaGuard had not begun generating revenue for BGLC as of June 30, 2026. Market entry depends on completing laboratory, validation and regulatory work, and the timing is uncertain. Form 10-Q, quarter ended June 30, 2026 (opens in a new tab)
2026 deployment phase announced
BGLC announced the start of its 2026 deployment phase for VitaGuard™, with initial deployments expected in select Southeast Asian medical hubs during 2026.
January 28, 2026 release (Form 8-K) (opens in a new tab)Fidelion Chief Commercial Officer appointed
Dr. Muthu Meyyappan was appointed Chief Commercial Officer of Fidelion Diagnostics to lead its international commercial strategy and partnerships.
March 11, 2026 release (Form 8-K) (opens in a new tab)Working visit to Tongshu Gene in China
A Fidelion-led team visited Tongshu Gene facilities in Shanghai and Changzhou and selected hospitals where, according to Tongshu Gene, VitaGuard is in paid commercial use. The visits were not a formal clinical evaluation. BGLC’s license covers ten Southeast Asian markets.
July 28, 2026 release (Form 8-K) (opens in a new tab)Laboratory preparation in Malaysia
Dr. Meyyappan spent approximately three weeks in Malaysia working with MRNA Scientific and other project participants on commercialization planning, laboratory preparation, partner coordination and implementation planning.
Form 10-Q, quarter ended June 30, 2026 (opens in a new tab)
Hospitals and laboratories interested in VitaGuard™ in Southeast Asia can contact BioNexus.