BioNexus Gene Lab Corp. and Fidelion Diagnostics Announce Landmark Alliance—Touted as a new “DeepSeek Moment” in Precision Oncology

Rhea-AI Summary

BioNexus Gene Lab Corp. (NASDAQ:BGLC) has announced a strategic partnership with Singapore's Fidelion Diagnostics, marking a significant advancement in precision oncology. The deal centers around VitaGuard™, a revolutionary liquid biopsy platform for cancer monitoring that can detect cancer recurrence through a simple blood test at just $300, compared to the current $3,000 cost in the U.S.

The partnership involves BGLC acquiring a strategic stake in Fidelion and securing exclusive commercial rights to VitaGuard™ across Southeast Asia. The technology, originally developed by China's Tongshu Gene Biotechnology, achieves 0.02% variant-allele-frequency sensitivity and offers 95% cfDNA recovery. With Southeast Asia's cancer cases projected to reach 2.4 million annually by 2030, this partnership targets a multi-billion-dollar market opportunity.

Positive

• None.

Negative

• Deal is subject to execution of definitive agreements
• Regulatory approvals still needed across ASEAN markets
• Technology licensing agreement with Tongshu Gene Biotechnology still pending completion

Insights

Biotechnology and Oncology Expert

BGLC's exclusive rights to VitaGuard™ could transform cancer monitoring by offering affordable, tumor-naïve liquid biopsies across Southeast Asia.

This partnership represents a potentially transformative development in cancer diagnostics. The VitaGuard™ platform offers two critical technological advantages that could disrupt the liquid biopsy market. First, it's tumor-naïve, meaning it can detect cancer recurrence without requiring previous tumor tissue samples—a significant improvement over most existing liquid biopsies. Second, it dramatically reduces testing costs from $3,000 to under $300, making regular cancer monitoring economically viable at population scale.

The technology's reported 0.02% variant-allele-frequency sensitivity with 95% cfDNA recovery is technically impressive. This sensitivity level allows detection of extremely small amounts of circulating tumor DNA, potentially identifying cancer recurrence months before conventional imaging. The 14-day room-temperature sample stability is equally significant, solving a major logistical challenge in tropical climates where cold-chain infrastructure is limited.

BGLC's exclusive commercial rights across ASEAN positions them to capture a substantial market, with Southeast Asia projected to see 2.4 million new cancer cases annually by 2030. The recurring revenue potential is substantial—cancer survivors require regular monitoring, creating a multi-billion dollar addressable market.

The comparison to "DeepSeek" appears to reference how this technology could represent a step-change in capabilities similar to recent AI breakthroughs. However, despite promising claims, investors should note that while VitaGuard™ is commercialized in China, specific clinical validation data and regulatory timelines for ASEAN markets aren't detailed in this announcement.

Healthcare Business Strategist

The cross-equity structure of this deal reveals sophisticated strategic thinking. Rather than a simple licensing agreement, both companies are taking ownership stakes in each other—creating aligned incentives for long-term collaboration. This structure mitigates risk while maximizing upside potential for both parties.

The market opportunity is compelling. Liquid biopsies represent one of healthcare's fastest-growing segments, with the global market projected to reach $25 billion by 2030. By dramatically reducing per-test costs while maintaining high sensitivity, VitaGuard™ could accelerate adoption in price-sensitive emerging markets where traditional $3,000+ tests remain prohibitively expensive.

BGLC's phased rollout strategy—beginning with Singapore and Malaysia before expanding across ASEAN—demonstrates a pragmatic approach. Singapore offers a sophisticated healthcare system and regulatory framework that can validate the technology before wider deployment, while Malaysia provides BGLC's home-market advantage.

The mention of companion diagnostics and AI development signals forward-thinking about building an ecosystem around the core technology. By collecting longitudinal minimal residual disease data across diverse Asian populations, the companies could develop valuable AI models specifically optimized for these underrepresented groups in cancer research.

This deal potentially positions BGLC as a significant player in the "China-Biotech Wave"—leveraging innovative Chinese biotechnology for commercialization across Southeast Asia. However, execution risks remain, as definitive agreements are still pending and regulatory approvals will be required across multiple jurisdictions.

KUALA LUMPUR, Malaysia, July 30, 2025 (GLOBE NEWSWIRE) -- BioNexus Gene Lab Corp. (“BGLC”, Nasdaq: BGLC) and Fidelion Diagnostics Pte Ltd, a Singaporean company (“Fidelion”) today announced the signing of a term sheet for a strategic, cross-equity partnership that the parties are calling a “DeepSeek-class leap” for liquid biopsy cancer monitoring and AI-driven biotechnology. This builds on BGLC’s mission to be a global leader in liquid biopsies, and tumor naïve oncology solutions.

Under the term sheet, BGLC will acquire a strategic equity stake in Fidelion and secure exclusive commercial rights to Fidelion’s VitaGuard™ minimal-residual-disease (MRD) platform across Southeast Asia (ASEAN). Fidelion, in turn, will receive an equity investment from BGLC together with a licence fee, aligning both companies for long-term shared value creation. The transaction is subject to the execution of definitive agreements by the parties.

What’s a Liquid Biopsy?
A simple blood draw that looks for fragments of tumour DNA (called ctDNA) circulating in the bloodstream. No scalpel, no hospital stay.

Why it Matters:
* Earlier warning. Cancer recurrence can be detected months before it shows up on a CT scan.
* Less hassle. One tube of blood vs. invasive tissue re-biopsies.
* Lower cost. Labs can now run VitaGuard™ tests for under USD $300, vs. ~USD $3,000 currently in the U.S.

Tumour-Naïve vs. Tumour-Informed:
Most ctDNA tests first need a slice of the original tumour (“tumour-informed”) to know what mutations to track. VitaGuard™ is tumour-naïve—it can spot the earliest traces of many cancers without prior tumour sequencing. It is similar in application to facial-recognition software for cancer except that it works even if it has never seen the face before.

Tongshu Gene Biotechnology Co., Limited, a company based in China, is the original developer of VitaGuard™ and Fidelion is intended to be the licensing arm for the technology under an agreement to be completed by the parties. The VitaGuard™ system is already commercialised in China.

The transaction arrives amidst China’s biopharma sector posting major licensing deal-flow and billions in venture capital and IPO proceeds over the last 18 months, fuelling what analysts dub the “China-Biotech Wave.”

One of the key innovations of VitaGuard™ technology is that it can slash per-patient MRD monitoring cost from more than US $3,000 to under US $300 and is supported by numerous positive clinical studies in China. With Southeast Asia’s cancer incidence projected to top 2.4 million new cases annually by 2030, a sub-US $300 test opens a multi-billion-dollar recurring market.

Sam Tan, Chief Executive Officer of BGLC, said:
“This alliance is nothing short of a paradigm shift - the moment precision oncology gets its own “DeepSeek-class” technology upgrade. By combining VitaGuard™ with our commercial network, we will deliver next-generation cancer care to 680 million people across Southeast Asia.”

Dr. Yan Linghua, Chief Executive Officer of Tongshu Gene and Executive Director of Fidelion, added:
“Our team in China spent years perfecting VitaGuard’s one-tube, high-fidelity chemistry. Building Fidelion for global commercialisation—and partnering with BGLC for Southeast Asia - creates the fastest possible path to scale. Together, we aim to shatter the cost-accuracy trade-off, bringing ultra-sensitive, AI-ready cancer surveillance to every clinic.”

Strategic Highlights

• “DeepSeek-Class” Technology – VitaGuard™ achieves 0.02 % variant-allele-frequency sensitivity with 95% cfDNA recovery and 14-day room-temperature sample stability while compressing cost 4-10× versus legacy assays.
• Market Access at Scale – BGLC will lead regulatory submissions and a phased roll-out beginning in Singapore and Malaysia, expanding rapidly through the rest of ASEAN.
• Mutual Skin in the Game – Cross-shareholdings cement long-term strategic alignment.
• Pipeline & AI Acceleration – The alliance contemplates joint development of companion-diagnostic programs and an AI-powered Cancer Interception System trained on VitaGuard™ longitudinal MRD datasets.

About Fidelion Diagnostics Pte. Ltd.

Fidelion is a next-generation liquid-biopsy company with a mission to ignite the “DeepSeek Moment” in biotechnology. The company’s proprietary VitaGuard™ platform, originally developed by Tongshu Gene in China, and to be assigned to Fidelion, couples ultra-efficient pre-analytical recovery with one-tube UMI chemistry to deliver industry-leading < 0.03 % LoD at a fraction of incumbent cost - precisely the high-fidelity data foundation required for AI-driven cancer interception.

About Tongshu Gene Biotechnology Co., Limited

Tongshu Gene, located in Wuxi, China, pioneered the core technology behind VitaGuard™, including its one-tube UMI workflow and dual DNA/RNA probing chemistry. Tongshu will remain Fidelion’s partner in manufacturing and R&D of the technology.

About BioNexus Gene Lab Corp.

BGLC is an innovation-led life-sciences platform – bringing together precision diagnostics, cross-border expertise, and AI data development. Listed on Nasdaq, BGLC’s mission is to make next-generation healthcare accessible, affordable, and actionable for every patient.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements regarding the completion of the proposed transaction, anticipated regulatory approvals, commercial launch plans, and the expected benefits of the partnership. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. Readers are cautioned not to place undue reliance on these statements. Except as required by law, BGLC, Fidelion, and Tongshu Gene disclaim any obligation to update forward-looking statements contained herein. Actual outcomes may differ materially due to risks relating to clinical performance, regulatory approvals, manufacturing scalability, commercialization, and market adoption in key geographies.

Investor & Media Contacts
BGLC Investor Relations • ir@bionexusgenelab.com
Fidelion Media Relations • media@fideliondx.com

FAQ

What is the significance of BGLC's partnership with Fidelion Diagnostics?

The partnership brings VitaGuard™, a revolutionary liquid biopsy platform, to Southeast Asia, reducing cancer monitoring costs from $3,000 to under $300 while providing early cancer detection capabilities.

How does BGLC's VitaGuard™ technology differ from traditional cancer monitoring methods?

VitaGuard™ is tumor-naïve, meaning it can detect cancer traces without prior tumor sequencing, unlike traditional tumor-informed tests. It works through a simple blood draw instead of invasive biopsies.

What is the market potential for BGLC's VitaGuard™ in Southeast Asia?

With Southeast Asia projected to have 2.4 million new cancer cases annually by 2030, and the test costing under $300, the technology addresses a multi-billion-dollar recurring market.

What are the technical specifications of BGLC's VitaGuard™ platform?

VitaGuard™ achieves 0.02% variant-allele-frequency sensitivity with 95% cfDNA recovery and maintains 14-day room-temperature sample stability.

When will BGLC launch VitaGuard™ in Southeast Asia?

BGLC plans a phased rollout beginning in Singapore and Malaysia, followed by expansion throughout ASEAN, pending regulatory approvals and definitive agreements.