Virax Biolabs Partners with Emory University on ViraxImmune™ Clinical Studies; Readies for FDA Pre-Submission Meeting in Early September

[Mij]

Newswise — LONDON, Aug. 26, 2025-- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on immune response detection and diagnostics, today announced it has signed a Research Services Agreement ("RSA") with Emory University's Center for the Advancement of Diagnostics for a Just Society ("ADJUST Center") to conduct clinical studies of ViraxImmune™. These studies will focus on immune profiling in individuals with post-viral syndromes, beginning with post-acute sequelae of SARS-CoV-2 ("PASC"), commonly known as long COVID.

Virax Biolabs Partners with Emory University on ViraxImmune™ Clinical Studies; Readies for FDA Pre-Submission Meeting in Early September | Newswise

Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an innovative biotechnology company focused on immune response detection and diagnostics, today announced it has signed a Research Services Agreement ("RSA") with Emory University's Center for the Advancement of Diagnostics...

www.newswise.com

 

[Joan Crawford]

Just seen this update:

Is this technically feasible? @Jonathan Edwards


#ME #LongCovid #Lyme

LONDON, Nov. 3, 2025 … Virax Biolabs Group Limited … an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases, today announced that it has successfully completed patient recruitment for its United Kingdom-based, multi-centre clinical study evaluating the performance of the ViraxImmune™ assay in detecting T cell dysfunction in Post-Acute Infection Syndromes ("PAIS"), including Long COVID, post-treatment Lyme disease ("PTLD"), and Myalgic Encephalomyelitis / Chronic Fatigue Syndrome ("ME/CFS") …

"It was hugely encouraging to see so many patients from across the country keen to contribute to this important research," said Dr James Shepherd, Consultant in Microbiology and Infectious Diseases at NHS Greater Glasgow and Clyde and Honorary Clinical Senior Lecturer at the MRC-University of Glasgow Centre for Virus Research, who serves as the study's Principal Investigator. "There is enormous demand for improved understanding and diagnostic tools for post-acute infection syndromes. The ViraxImmune™ platform represents an exciting step forward in the scientific and clinical approach to these complex immune conditions." …

"Completing full UK clinical recruitment ahead of schedule, alongside receiving constructive FDA feedback, represents an important dual milestone for ViraxImmune™. Together, these achievements strengthen our global regulatory position and advance our goal of enabling T cell-based immune profiling to improve diagnosis and management of post-acute infection syndromes."

Virax Biolabs Completes UK Clinical Recruitment and Reports Constructive FDA Feedback for ViraxImmune™ Study Evaluating T Cell Dysfunction in Post-Acute Infection Syndromes

LONDON, Nov. 3, 2025 /PRNewswire/ -- Virax Biolabs Group Limited (NASDAQ: VRAX) ("Virax" or the "Company"), an…...

ir.viraxbiolabs.com

 

[Jonathan Edwards]

Is this technically feasible? @Jonathan Edwards

No doubt the test is technically feasible but I don't think anyone has any idea what it might mean or what use it would be.

T cell dysfunction doesn't mean anything. It might mean T cells doing the wrong thing in a particular context but since we don't know what the context is or what would be right for T cells to do in it...

 

[V.R.T.]

No doubt the test is technically feasible but I don't think anyone has any idea what it might mean or what use it would be.

T cell dysfunction doesn't mean anything. It might mean T cells doing the wrong thing in a particular context but since we don't know what the context is or what would be right for T cells to do in it...

Surely if we want to find out whether certain kinds of t cells and cytokines are involved in Me/CFS a test like this would be a useful tool to help figure that out?

 

[Jonathan Edwards]

Surely if we want to find out whether certain kinds of t cells and cytokines are involved in Me/CFS a test like this would be a useful tool to help figure that out?

Some lab experiments could be useful. I don't see any need for those experiments to be given a trademark until we know if they show anything interpretable.

 

[V.R.T.]

Some lab experiments could be useful. I don't see any need for those experiments to be given a trademark until we know if they show anything interpretable.

Agreed on the trademark front.

It seems like they released data from ten participants earlier this year.

Evaluation of T cell dysfunction in Post Acute Infection Syndromes

Nigel McCracken, Lucy Buckingham, and Clément Monteil

Virax Biolabs, BioCity Glasgow, Scotland, UK

https://viraxbiolabs.com/wp-content/uploads/2025/03/WIRMposter_printing.pdf

They're claiming differences in t cells but also marked differences IFN-G, IL2, IL-10 and granzyme B

Wasnt there another flurospot or elispot study that showed elevated ifn-g in long covid that you were a fan of earlier this year?

 

[Jonathan Edwards]

Wasnt there another flurospot or elispot study that showed elevated ifn-g in long covid that you were a fan of earlier this year?

Probably was. I didn't think we were at the stage of rolling this out as a commercial test though. The diagnosis is clinical. The test might suggest some altered immunology but so far we have no idea what to do about that.

 

[hotblack]

Initial read-outs from this longitudinal study are expected in Q2 2026.

That seems the important bit. It would be good to know more about the study and what we may be able to learn from it rather than the PR stuff.

Thanks for the link @V.R.T.
So from that pdf this is why they say their tech is special

FluoroSpot-based assay capable of sensitive multiplexed quantification of cytokine secretion at the single-cell level

And here is the clinical trial info which states

Participants that experience symptoms considered to be associated with a diagnosis of long COVID, PTLDS or ME/CFS will consent to the study, and attend for two study visits (at study entry and 6 months) to complete a questionnaire related to their symptoms, and to have a blood sample taken. Blood samples will be taken either at the clinical site or at the participant's home if they are unable to attend due to the severity of their illness. .

Participants will be allocated to one of the following groups:
Group 1: Long COVID Group 2: ME/CFS Group 3: PTLDS Group 4: Healthy Control

With the prinary outcome measure

To evaluate the performance of the ViraxImmune FluoroSpot T cell assay to identify T cell dysfunction in participants diagnosed with long COVID, post treatment Lyme disease (PTLD) and Myalgic Encephalomyelitis/Chronic Fatigue (ME/CFS)