VisGene has been advancing research and development to bring antibody technology for identifying all four dengue virus serotypes into practical medical use. We are pleased to announce that our in vitro diagnostic, “VisCheck™ Dengue NS1 Rapid Antigen Serotyping Test,” has now received Certificate of Sales from Thai-FDA since January 2025.
URL:Product Catalogue for Solutions to Global Health Challenges_Aug 202025.pdf
Addressing Critical Healthcare Challenges
Dengue fever affects over 400 million people annually across 100+ countries, with case fatality rates reaching 20-30% without appropriate treatment.
The medical community has long struggled with the inability to predict severe disease progression and identify specific dengue virus serotypes rapidly.
VisGene Ltd’s groundbreaking VisCheck™ Dengue NS1 Rapid Antigen Serotyping Test represents a paradigm shift in dengue diagnostics, offering the world’s first serotype-specific rapid test with severe disease prediction capabilities.
World-First Technological Breakthrough
The VisCheck™ Dengue NS1 Rapid Antigen Serotyping Test achieves what no other diagnostic tool has accomplished: simultaneous serotype identification and severe disease risk prediction in just 15 minutes. This revolutionary capability addresses the critical medical need for rapid, actionable diagnostic information in dengue management.
| Specification | Details |
|---|---|
| Product Name | VisCheck™ Dengue NS1 Rapid Antigen Serotyping Test |
| Test Time | 15 minutes |
| Sample Type | Serum |
| Detection Target | NS1 Antigen (Serotypes 1-4) |
| Pack Size | 25 tests per box |
| Regulatory Status | Thailand FDA Approved |
| Launch Date | January 2025 |
Competitive Landscape Analysis
The diagnostic market has been dominated by technologies that offer limited clinical utility. VisCheck™ establishes a new category of dengue diagnostics with unprecedented capabilities.
| Technology | Test Time | Serotype ID | Severity Prediction | Sensitivity | Clinical Utility |
|---|---|---|---|---|---|
| VisCheck™ | 15 minutes | ✓ All 4 serotypes | ✓ Yes | High | Complete |
| PCR Testing | 2-24 hours | ✓ Yes | ✓ Yes | High | Limited |
| Conventional Rapid Tests | 15-30 minutes | ✗ No | ✗ No | Moderate | Basic |
| ELISA | 2-4 hours | ✓ Yes | ✓ Yes | High | Limited |
Market Drivers
- Climate Change Impact: Expanding vector habitats increase dengue transmission zones
- Urbanization: Dense populations create optimal breeding environments for Aedes mosquitoes
- Travel Globalization: Increased international mobility spreads virus variants
- Healthcare Infrastructure Development: Growing diagnostic capabilities in endemic regions
- Government Surveillance Programs: Public health initiatives drive testing demand
Clinical Benefits and Healthcare Impact
- Enhanced Diagnostic Accuracy: Serotype-specific identification enables precise risk assessment
- Improved Patient Triage: Immediate severity prediction guides resource allocation
- Reduced Hospital Stays: Appropriate treatment decisions minimize unnecessary admissions
- Cost Optimization: Efficient use of medical resources reduces operational costs
For Patients
- Improved Outcomes: Early intervention based on severity prediction
- Reduced Mortality: Appropriate treatment reduces fatality rates to <0.5%
- Faster Diagnosis: 15-minute results eliminate anxiety from waiting
- Personalized Treatment: Serotype-specific therapy optimization
Clinical Evidence and Performance
Clinical validation demonstrates VisCheck™’s superior performance in real-world healthcare settings:
Key Performance Metrics
- Sensitivity: High-sensitivity NS1 antigen detection comparable to PCR during acute phase (Days 0-7)
- Specificity: Serotype-specific antibodies eliminate cross-reactivity
- Speed: 94% faster than PCR testing (15 minutes vs. 4-24 hours)
- Clinical Impact: Enables mortality reduction from 20-30% to <0.5% with appropriate treatment
Economic Value Proposition
Cost-Effectiveness Analysis
VisCheck™ delivers substantial economic benefits across the healthcare system:
- Reduced Hospital Costs: Appropriate triage minimizes unnecessary ICU admissions
- Improved Bed Utilization: Faster discharge of low-risk patients improves turnover
- Laboratory Efficiency: Point-of-care testing reduces central lab workload
- Prevention of Outbreaks: Rapid serotype identification enables targeted public health responses
Return on Investment
Healthcare facilities implementing VisCheck™ can expect:
- Reduced diagnostic costs per patient through efficient testing protocols
- Decreased liability from missed diagnoses or inappropriate treatment
- Enhanced reputation as a center of excellence for infectious disease management
- Improved patient satisfaction through rapid, accurate diagnosis
Regulatory Approval and Quality Assurance
Thailand FDA Registration
VisCheck™ has received full registration approval from the Thailand Food and Drug Administration, marking a significant milestone as the world’s first approved serotype-specific rapid dengue diagnostic. This approval follows rigorous clinical validation and demonstrates the product’s safety and efficacy in real-world healthcare settings.
Global Expansion Strategy
Following successful Thailand launch in January 2025, VisGene plans strategic expansion to key dengue-endemic regions:
Developed Markets: USA, Europe, Japan (travel medicine and reference laboratories)
Southeast Asia: Vietnam, Malaysia, Singapore, Philippines, Indonesia
Latin America: Brazil, Mexico, Colombia, Peru, Argentina
Africa: Nigeria, Ghana, Kenya, Uganda
Distribution and Availability
VisCheck™ will be available through established medical device distribution networks, ensuring reliable supply and local support across target markets. The initial focus on Thailand provides a strong foundation for regional expansion and market validation.
Future Outlook and Innovation Pipeline
Technology Development
VisGene continues to advance diagnostic innovation with planned enhancements:
- Multiplex Testing: Combined dengue, Zika, and chikungunya detection
- Digital Integration: Smartphone-based result reading and data management
- Expanded Biomarkers: Additional predictive markers for severe disease
- Point-of-Care Platforms: Integrated testing systems for resource-limited settings
Product information
- Year of launch：2025
- Unit of sale：1 box (25 test)
- Company name VisGene Ltd
- Model number VCDV066, VisCheck DVNS1 – 25 test/Box
VisCheck™ Dengue NS1 Rapid Antigen Serotyping Test represents more than a diagnostic innovation—it’s a paradigm shift that will save lives and transform dengue care globally. By providing the world’s first serotype-specific rapid test with severe disease prediction capabilities, VisGene has created a solution that addresses critical unmet medical needs while delivering substantial economic value.
The Thailand FDA approval and January 2025 commercial launch mark the beginning of a new era in dengue diagnostics. Healthcare providers now have access to a tool that enables personalized, evidence-based treatment decisions in real-time, ultimately reducing mortality rates from 20-30% to less than 0.5% through appropriate clinical management.
For healthcare administrators, medical device distributors, and clinical practitioners seeking to enhance their dengue diagnostic capabilities, VisCheck™ offers an unprecedented combination of clinical utility, economic value, and competitive advantage in the rapidly growing global diagnostics market.