Virax Biolabs Reports Positive Early Data for Long COVID Test
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 5 days ago
0mins
Virax Biolabs Group reported positive early pilot performance data for ViraxImmune its blood-based test in development for Long COVID, myalgic encephalomyelitis/chronic fatigue syndrome, or ME/CFS, and related post-acute infection syndromes, or PAIS. In the pilot dataset, ViraxImmune demonstrated measurable separation between PAIS patients and healthy controls, achieving 88% specificity and 92% positive predictive value, or PPV - early performance metrics that Virax believes support continued development and advancement into larger clinical validation. Based on estimates derived from CDC, the RECOVER Initiative and other peer-reviewed and public-health sources, Virax estimates that up to 21 million adults in the U.S. may currently be living with Long COVID and related PAIS conditions, with approximately 2.5 million new cases estimated each year. Virax believes this represents a significant potential U.S. testing opportunity in an area where many patients are often assessed through symptoms and exclusion, rather than objective immune biomarkers of the type ViraxImmune is being developed to assess. Highlights include: In the pilot dataset, ViraxImmune demonstrated measurable separation between PAIS patients and healthy controls and achieved 88% specificity and 92% PPV; ViraxImmune has now been evaluated in more than 120 subjects in the Company's ongoing UK clinical study in Long COVID, ME/CFS and related post-acute infection syndromes; Virax is preparing for its next major development milestone: a larger clinical validation analysis involving previously collected samples from 300 additional participants, with analysis expected to begin in Q4 2026 and results expected in Q1 2027. ViraxImmune is in development and is not approved for diagnostic use in any jurisdiction. The VRX003 observations are preliminary and are intended to inform ongoing assay development and future clinical validation planning.
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About VRAX
Virax Biolabs Group Limited is a biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. The Company is engaged in developing ViraxImmune with the intention of providing an immunology profiling platform that assesses each individual’s immune risk profile against global viral diseases as well as helping with the early diagnosis of post-viral syndromes associated with T cell exhaustion and chronic inflammation. Its product portfolio includes ViraxClear and ViraxVet. ViraxClear offers a range of accurate diagnostic testing kits and machines. ViraxVet offers various rapid and molecular tests for small animal veterinary diagnostics. The Company is initially focused on diseases associated with post-viral syndromes, including SARS-CoV-2, Human Papillomavirus (HPV), Malaria, Hepatitis B, and Herpes (HSV-1).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Virax Biolabs Reports Positive Early Data for ViraxImmune™ Test
- Early Data Performance: ViraxImmune™ demonstrated 88% specificity and 92% positive predictive value in tests for Long COVID and chronic fatigue syndrome, indicating its potential in objective immune biomarker assessment, which may drive further clinical validation.
- Significant Market Opportunity: Estimates from the CDC and the RECOVER Initiative suggest that approximately 21 million adults in the U.S. may suffer from Long COVID and related conditions, with about 2.5 million new cases annually, presenting a substantial testing opportunity for Virax, especially where traditional symptom assessments fall short.
- Clinical Validation Plans: Virax aims to validate ViraxImmune™ through larger clinical studies, and if successful, it could become the first objective immune profiling method specifically for Long COVID and related syndromes, playing a crucial role in patient stratification and clinical decision-making.
- Investor Webcast Announcement: Virax will host an investor webcast on May 26, 2026, to discuss the early dataset and its clinical and commercial implications, showcasing the company's planned path toward U.S. market entry, thereby enhancing investor confidence.
See More
Virax Biolabs Reports Positive Early Data for ViraxImmune™ Test
- Early Pilot Data: ViraxImmune™ demonstrated 88% specificity and 92% positive predictive value in its pilot study for Long COVID, ME/CFS, and related post-acute infection syndromes, indicating its potential to transform existing diagnostic approaches through objective immune biomarker assessment.
- Market Opportunity Assessment: With estimates from the CDC and the RECOVER Initiative suggesting that up to 21 million adults in the U.S. may be living with Long COVID and related conditions, and approximately 2.5 million new cases each year, Virax sees a significant testing opportunity in a market lacking objective testing options.
- Clinical Validation Plans: Virax is preparing to conduct a larger clinical validation analysis involving samples from 300 additional participants, expected to begin in Q4 2026 with results anticipated in Q1 2027, which will lay the groundwork for its U.S. market entry and further product development.
- Strategic Implications: If validated in larger studies, ViraxImmune™ could become the first objective immune profiling method specifically for Long COVID and related syndromes, playing a crucial role in patient stratification, clinical decision-making, and therapeutic development, thereby addressing a significant unmet diagnostic need.
See More
Virax Biolabs Advances U.S. Market Strategy with ViraxImmune™
- Strategic Focus: Virax Biolabs is concentrating on advancing the development of ViraxImmune™ and plans to enter the U.S. market, with management believing that the current valuation does not reflect the company's strong balance sheet and debt-free status.
- Clinical Validation Progress: The company is preparing for a key readout of PAIS data, which is expected to help assess the effectiveness of ViraxImmune™ in identifying immune dysfunction patterns, providing crucial insights for U.S. clinical validation planning.
- Strong Financial Position: As of March 31, 2026, Virax reported a cash balance of approximately $6.4 million, total assets of about $8.3 million, and liabilities of only $1 million, indicating a healthy financial status in a challenging small-cap market.
- Market Opportunity: PAIS is identified as an underserved diagnostic category with an estimated U.S. economic burden exceeding $25 billion, and the development of ViraxImmune™ aims to fill this market gap, thereby driving future value creation for the company.
See More
Virax Biolabs Advances U.S. Market Strategy with ViraxImmune™
- Market Opportunity Assessment: Virax Biolabs identifies post-acute infection syndromes (PAIS), including Long COVID, as a significant underserved market with an economic burden exceeding $25 billion, highlighting substantial commercial potential due to the lack of widely adopted objective testing methods.
- Product Development Progress: The ViraxImmune™ kit is under development to identify immune dysfunction in PAIS using a novel proprietary assay, which is expected to pave the way for the company's entry into the U.S. market and enhance its competitive position.
- Operational Milestones: The company has fully recruited participants for its UK PAIS studies and is planning U.S. clinical validation with Emory University, while also achieving ISO 13485 and ISO 9001 certifications to ensure quality and compliance in product development.
- Strong Financial Position: As of March 31, 2026, Virax's cash position is approximately $6.4 million with no long-term debt, and management believes the current market capitalization of about $2.6 million does not reflect the company's assets and clinical progress, indicating a market undervaluation of its potential.
See More
Virax Biolabs Achieves ISO Certifications for Quality Management
- Quality Management Certification: Virax Biolabs (UK) Limited has achieved ISO 13485:2016 and ISO 9001:2015 certifications, issued by LRQA on February 18, 2026, valid until February 17, 2029, significantly enhancing the company's quality management capabilities in the medical device and diagnostics sectors.
- Support for Product Development: The ISO 13485 certification covers the design and development of immunological assay components and reagents, while ISO 9001 supports the manufacturing of Virax's research-use-only products, bolstering the company's competitive edge in IVD applications.
- Foundation for Clinical Validation: Virax believes these certifications provide a crucial operational foundation for its clinical validation efforts, particularly in developing diagnostic technologies for post-acute infection syndromes like Long COVID, facilitating progress in U.S. clinical studies.
- Strategic Development Opportunity: The Research Services Agreement with Emory University will advance clinical studies on immune profiling, and combined with the ISO certifications, is expected to accelerate Virax's commercialization efforts in the U.S. market, further solidifying its position in the global immune diagnostics field.
See More
Virax Biolabs Achieves ISO 13485 and ISO 9001 Certifications
- Quality Management Certification: Virax Biolabs (UK) Limited has achieved ISO 13485:2016 and ISO 9001:2015 certifications, issued by LRQA on February 18, 2026, valid until February 17, 2029, marking international recognition of the company's quality management in medical devices and diagnostics.
- Support for PAIS Strategy: These certifications strengthen Virax's quality framework for its post-acute infection syndromes (PAIS) strategy, enhancing readiness for regulated in vitro diagnostic (IVD) development and U.S. clinical validation activities, thereby increasing market competitiveness.
- Clinical Validation Partnership: Virax has entered into a Research Services Agreement with Emory University's ADJUST Center to conduct clinical studies focused on PASC (Long COVID), leveraging the strengthened quality systems from the ISO certifications to support clinical data generation for future commercial rollout.
- Strategic Development Foundation: Virax believes that the ISO certifications provide an important operational foundation for its quality-managed development activities, supporting standardized processes in IVD development and clinical programs, further advancing the company's strategic positioning in immune testing technologies.
See More
Virax Biolabs Reports Positive Early Data for ViraxImmune™ Test
- Early Data Performance: ViraxImmune™ demonstrated 88% specificity and 92% positive predictive value in tests for Long COVID and chronic fatigue syndrome, indicating its potential in objective immune biomarker assessment, which may drive further clinical validation.
- Significant Market Opportunity: Estimates from the CDC and the RECOVER Initiative suggest that approximately 21 million adults in the U.S. may suffer from Long COVID and related conditions, with about 2.5 million new cases annually, presenting a substantial testing opportunity for Virax, especially where traditional symptom assessments fall short.
- Clinical Validation Plans: Virax aims to validate ViraxImmune™ through larger clinical studies, and if successful, it could become the first objective immune profiling method specifically for Long COVID and related syndromes, playing a crucial role in patient stratification and clinical decision-making.
- Investor Webcast Announcement: Virax will host an investor webcast on May 26, 2026, to discuss the early dataset and its clinical and commercial implications, showcasing the company's planned path toward U.S. market entry, thereby enhancing investor confidence.
See More
Virax Biolabs Reports Positive Early Data for ViraxImmune™ Test
- Early Pilot Data: ViraxImmune™ demonstrated 88% specificity and 92% positive predictive value in its pilot study for Long COVID, ME/CFS, and related post-acute infection syndromes, indicating its potential to transform existing diagnostic approaches through objective immune biomarker assessment.
- Market Opportunity Assessment: With estimates from the CDC and the RECOVER Initiative suggesting that up to 21 million adults in the U.S. may be living with Long COVID and related conditions, and approximately 2.5 million new cases each year, Virax sees a significant testing opportunity in a market lacking objective testing options.
- Clinical Validation Plans: Virax is preparing to conduct a larger clinical validation analysis involving samples from 300 additional participants, expected to begin in Q4 2026 with results anticipated in Q1 2027, which will lay the groundwork for its U.S. market entry and further product development.
- Strategic Implications: If validated in larger studies, ViraxImmune™ could become the first objective immune profiling method specifically for Long COVID and related syndromes, playing a crucial role in patient stratification, clinical decision-making, and therapeutic development, thereby addressing a significant unmet diagnostic need.
See More
Virax Biolabs Advances U.S. Market Strategy with ViraxImmune™
- Strategic Focus: Virax Biolabs is concentrating on advancing the development of ViraxImmune™ and plans to enter the U.S. market, with management believing that the current valuation does not reflect the company's strong balance sheet and debt-free status.
- Clinical Validation Progress: The company is preparing for a key readout of PAIS data, which is expected to help assess the effectiveness of ViraxImmune™ in identifying immune dysfunction patterns, providing crucial insights for U.S. clinical validation planning.
- Strong Financial Position: As of March 31, 2026, Virax reported a cash balance of approximately $6.4 million, total assets of about $8.3 million, and liabilities of only $1 million, indicating a healthy financial status in a challenging small-cap market.
- Market Opportunity: PAIS is identified as an underserved diagnostic category with an estimated U.S. economic burden exceeding $25 billion, and the development of ViraxImmune™ aims to fill this market gap, thereby driving future value creation for the company.
See More
Virax Biolabs Advances U.S. Market Strategy with ViraxImmune™
- Market Opportunity Assessment: Virax Biolabs identifies post-acute infection syndromes (PAIS), including Long COVID, as a significant underserved market with an economic burden exceeding $25 billion, highlighting substantial commercial potential due to the lack of widely adopted objective testing methods.
- Product Development Progress: The ViraxImmune™ kit is under development to identify immune dysfunction in PAIS using a novel proprietary assay, which is expected to pave the way for the company's entry into the U.S. market and enhance its competitive position.
- Operational Milestones: The company has fully recruited participants for its UK PAIS studies and is planning U.S. clinical validation with Emory University, while also achieving ISO 13485 and ISO 9001 certifications to ensure quality and compliance in product development.
- Strong Financial Position: As of March 31, 2026, Virax's cash position is approximately $6.4 million with no long-term debt, and management believes the current market capitalization of about $2.6 million does not reflect the company's assets and clinical progress, indicating a market undervaluation of its potential.
See More
Virax Biolabs Achieves ISO Certifications for Quality Management
- Quality Management Certification: Virax Biolabs (UK) Limited has achieved ISO 13485:2016 and ISO 9001:2015 certifications, issued by LRQA on February 18, 2026, valid until February 17, 2029, significantly enhancing the company's quality management capabilities in the medical device and diagnostics sectors.
- Support for Product Development: The ISO 13485 certification covers the design and development of immunological assay components and reagents, while ISO 9001 supports the manufacturing of Virax's research-use-only products, bolstering the company's competitive edge in IVD applications.
- Foundation for Clinical Validation: Virax believes these certifications provide a crucial operational foundation for its clinical validation efforts, particularly in developing diagnostic technologies for post-acute infection syndromes like Long COVID, facilitating progress in U.S. clinical studies.
- Strategic Development Opportunity: The Research Services Agreement with Emory University will advance clinical studies on immune profiling, and combined with the ISO certifications, is expected to accelerate Virax's commercialization efforts in the U.S. market, further solidifying its position in the global immune diagnostics field.
See More
Virax Biolabs Achieves ISO 13485 and ISO 9001 Certifications
- Quality Management Certification: Virax Biolabs (UK) Limited has achieved ISO 13485:2016 and ISO 9001:2015 certifications, issued by LRQA on February 18, 2026, valid until February 17, 2029, marking international recognition of the company's quality management in medical devices and diagnostics.
- Support for PAIS Strategy: These certifications strengthen Virax's quality framework for its post-acute infection syndromes (PAIS) strategy, enhancing readiness for regulated in vitro diagnostic (IVD) development and U.S. clinical validation activities, thereby increasing market competitiveness.
- Clinical Validation Partnership: Virax has entered into a Research Services Agreement with Emory University's ADJUST Center to conduct clinical studies focused on PASC (Long COVID), leveraging the strengthened quality systems from the ISO certifications to support clinical data generation for future commercial rollout.
- Strategic Development Foundation: Virax believes that the ISO certifications provide an important operational foundation for its quality-managed development activities, supporting standardized processes in IVD development and clinical programs, further advancing the company's strategic positioning in immune testing technologies.
See More
