Fidelion Diagnostics

What Fidelion Diagnostics does

Fidelion Diagnostics Pte Ltd is a Singapore-headquartered, privately held biotechnology company commercializing the VitaGuard™ platform, an AI-enabled liquid biopsy test for oncology diagnostics. The core offering targets Minimal Residual Disease (MRD) monitoring — detecting molecular residual disease months or years earlier than imaging — using proprietary cell-free DNA (cfDNA) recovery combined with high-frequency sequencing workflows. The company claims a roughly 90% per-patient cost reduction relative to incumbent MRD testing, targeting sub-US$300 pricing versus an industry baseline above US$3,000.

The underlying technology was originally developed in China by Tongshu Gene Biotechnology Co., Limited, which retains manufacturing and R&D responsibilities, while Fidelion serves as the exclusive international IP commercialization vehicle outside Greater China. In December 2025, Fidelion entered a cross-equity strategic transaction with NASDAQ-listed BioNexus Gene Lab Corp. (BGLC), granting BioNexus exclusive perpetual rights to manufacture, market, and distribute VitaGuard across all ASEAN markets, alongside reciprocal equity stakes of approximately 15% (BGLC in Fidelion) and 16.6% (Fidelion in BGLC). BioNexus is leading regulatory submissions starting in Singapore and Malaysia, with sequential expansion planned across the broader ASEAN region.

Commercially, the company runs a dual-revenue model: usage-based fees from per-patient MRD testing services, and licensing fees from the ASEAN partner payable over 24 monthly installments. The primary customer segment is oncology healthcare providers — hospitals, cancer centers, and oncology practices across ASEAN serving 680 million citizens and an estimated 2.4 million annual cancer cases by 2030. Beyond the current MRD product, Fidelion has publicly articulated a second-horizon plan to leverage the longitudinal molecular data generated by VitaGuard testing to build a predictive "AI Survivability Engine" intended to intercept cancer before clinical onset.

Name

Fidelion Diagnostics

Legal name

Fidelion Diagnostics Pte Ltd

Website

https://www.fideliondx.com/

Company type

Private

Operating status

Operating

Short description

Fidelion Diagnostics Pte Ltd is a Singapore-based private biotechnology company commercializing VitaGuard™, an AI-enabled liquid biopsy platform for cancer recurrence monitoring via Minimal Residual Disease (MRD) detection, serving oncology healthcare providers across ASEAN markets through an exclusive partnership with NASDAQ-listed BioNexus Gene Lab Corp.

Ownership category

akta.pro rank

Product category

Oncology Diagnostics

NAICS

Medical Laboratories (621511), In-Vitro Diagnostic Substance Manufacturing (325413)

SIC

In Vitro & In Vivo Diagnostic Substances (2835), Services-Medical Laboratories (8071)

akta.pro primary industry

Liquid Biopsy & Minimal Residual Disease (MRD) Precision Testing (HLAAANAG)

akta.pro secondary industries

Oncology Diagnostics (tumor profiling, MRD, liquid biopsy) (HLAAALAE), Clinical Biomarker Testing Services (central labs, trial enrollment/monitoring assays) (HLAAAMAC)

Keywords

• Liquid biopsy diagnostics
• Cancer MRD monitoring
• CfDNA analysis
• Oncology testing services
• Molecular diagnostics

Headquarters

HQ city

Singapore

HQ country

Singapore

HQ region

Asia

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Revenue model

1. VitaGuard MRD Testing Services: Revenue from liquid biopsy testing services for cancer recurrence monitoring. The partnership aims to slash per-patient MRD monitoring costs from over US$3,000 to under US$300, making routine cancer monitoring accessible across ASEAN markets.
2. Licensing Fees: License fee for exclusive rights to manufacture, market, and distribute the VitaGuard platform across ASEAN markets, payable over 24 monthly installments.

Pricing tiers

Go-to-market motion2 records

Distribution channels2 records

Marketing channels2 records

Core offering

Fidelion Diagnostics develops and commercializes VitaGuard™, an AI-enabled liquid biopsy platform for Minimal Residual Disease (MRD) monitoring. The platform analyzes cell-free DNA (cfDNA) from blood samples to detect cancer recurrence in post-treatment patients, targeting the oncology diagnostics market across ASEAN and global markets.

Product overview

Fidelion Diagnostics offers a single unified product platform called VitaGuard™, an AI-driven liquid biopsy technology for cancer diagnostics. The platform currently provides MRD (Minimal Residual Disease) monitoring through ultra-sensitive liquid biopsy testing, while simultaneously serving as a data acquisition engine for future AI-powered predictive analytics. The VitaGuard™ platform represents both the current clinical offering and the foundation for the company's planned 'AI Survivability Engine' that will leverage longitudinal cancer datasets for predictive cancer interception.

Differentiator

Problem solved

Functional benefit

Brands

• VitaGuard™: AI-enabled liquid biopsy platform for minimal residual disease (MRD) monitoring and cancer recurrence detection. The platform is designed to provide affordable cancer monitoring by targeting cost profiles below $3,000, aiming to reduce per-patient MRD monitoring costs from over US$3,000 to under US$300.

Products and services

• VitaGuard™ Liquid Biopsy Platform

Quantifiable outcome

• Cost reduction from over US$3,000 to under US$300 per patient for MRD monitoring
• +2 more outcomes

Segments2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

AI capability3 records

Feature3 records

Partnerships

Two partnerships are on record, tiered core.

• BioNexus Gene Lab Corp.coreChannel Partner/ Reseller/ Distributor · 3 December 2025BioNexus acquired a 15% equity stake in Fidelion Diagnostics and Fidelion simultaneously acquired approximately 16.6% of BGLC's stock. BioNexus secured exclusive, perpetual rights to manufacture, market, and distribute the VitaGuard AI-enabled liquid biopsy platform across all ASEAN markets. The transaction establishes a dual-asset model positioning BGLC as both commercial operator in Southeast Asia's precision oncology market and strategic shareholder in Fidelion's global AI-oncology platform.
• Tongshu Gene Biotechnology Co., LimitedcoreTechnology or Integration · 30 July 2025Tongshu Gene is the original technology developer and manufacturing partner for the VitaGuard platform, originally developed in China. They remain responsible for manufacturing and R&D while Fidelion handles international commercialization. A Patent Support Agreement was also signed formalizing IP collaboration.

Scale indicators5 records

Recent moves6 records

Expansion highlights5 records

Direct peers

• Guardant Health: US-based leader in liquid biopsy and oncology diagnostics with established MRD/recurence-monitoring products. Directly comparable to Fidelion because both sell cfDNA-based oncology tests targeting oncologists and cancer patients, though Guardant operates at much greater global scale and clinical evidence depth.
• Natera: Developer of the Signatera MRD liquid biopsy assay, a direct clinical competitor to VitaGuard. Both companies offer tumor-informed cfDNA testing for cancer recurrence monitoring to oncology practices and hospital systems.
• Burning Rock Biotech: China-based oncology diagnostics and liquid biopsy company. Highly comparable given Fidelion's China-origin technology (via Tongshu Gene) and ASEAN-focused commercialization, mirroring Burning Rock's geographic strategy and cancer testing menu.

Others

• Bio-Techne: Supplies reagents, immunoassays, and analytical tools used in cancer diagnostics and liquid biopsy workflows. Comparable as an enabling technology and reagents provider for the cfDNA/immunoassay workflows underlying VitaGuard's platform.

Broad incumbents

• Tempus AI: AI-enabled precision medicine company combining multi-omics, clinical data, and AI for oncology. Comparable through the 'AI-driven longitudinal cancer dataset' positioning VitaGuard uses, though Tempus operates at far broader scale across diagnostics and data services.
• NeoGenomics: US oncology-focused clinical laboratory services and diagnostics provider covering MRD, liquid biopsy, and broader oncology testing. Comparable as an established player offering overlapping oncology diagnostic services to hospitals and oncologists.
• Exact Sciences: Large diagnostics company with a growing oncology franchise (Cologuard, Oncodetect MRD). Comparable as a broadly diversified diagnostics incumbent expanding into the same MRD/liquid biopsy category VitaGuard targets.
• Foundation Medicine (Roche): Roche-owned leader in comprehensive genomic profiling for oncology. Comparable as an established oncology diagnostics incumbent with broad hospital and pharma relationships that could compete with or complement VitaGuard in precision oncology.

Emerging players

• Personalis: US-based cancer genomics company with tumor-informed MRD and immunotherapy response products. Comparable as an emerging liquid biopsy/MRD competitor, though at an earlier commercial stage and smaller scale than Guardant or Natera.

Regional players

• Genetron Holdings: China-based precision oncology company offering NGS-based cancer diagnostics and MRD-style monitoring. Comparable as a regional precision oncology player using cfDNA/sequencing workflows, but primarily serves the China market rather than ASEAN.

Market position

Strengths4 records

Weaknesses5 records

Competitive moat5 records

Key risks6 records

Key highlights7 records

Customer concentration

Revenue estimate

Valuation estimate

Number of profiles

Funding overview

Funding rounds1 record

Investors1 record

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Fidelion Diagnostics