Virax Biolabs Partners with Emory University on ViraxImmune鈩� Clinical Studies; Readies for FDA Pre-Submission Meeting in Early September
Virax Biolabs (NASDAQ:VRAX) has entered into a Research Services Agreement with Emory University's ADJUST Center to conduct clinical studies of ViraxImmune鈩�, focusing on immune profiling in post-viral syndromes, particularly long COVID (PASC).
The company is preparing for a pre-submission meeting with the FDA in early September 2025 to discuss ViraxImmune鈩�'s regulatory pathway and intended use. Emory's Laboratory for Innovative Assay Development (ELIAD) will handle patient recruitment, testing, and analysis to generate clinical data supporting regulatory submissions.
ViraxImmune鈩� is a T cell testing technology that evaluates patient immune response profiles, offering potential advantages over traditional antibody testing for diagnosing chronic and post-viral conditions.
Virax Biolabs (NASDAQ:VRAX) ha sottoscritto un Research Services Agreement con il ADJUST Center della Emory University per condurre studi clinici su ViraxImmune鈩�, con un focus sul profiling immunitario nelle sindromi post-virali, in particolare il long COVID (PASC).
La societ脿 si sta preparando per un incontro pre-sottomissione con la FDA all'inizio di settembre 2025 per discutere il percorso regolatorio e l'utilizzo previsto di ViraxImmune鈩�. Il Laboratory for Innovative Assay Development (ELIAD) di Emory gestir脿 il reclutamento dei pazienti, i test e le analisi per produrre dati clinici a supporto delle richieste regolatorie.
ViraxImmune鈩� 猫 una tecnologia di test per cellule T che valuta i profili di risposta immunitaria dei pazienti, offrendo potenziali vantaggi rispetto ai tradizionali test anticorpali nella diagnosi di condizioni croniche e post-virali.
Virax Biolabs (NASDAQ:VRAX) ha suscrito un Research Services Agreement con el ADJUST Center de la Emory University para realizar estudios cl铆nicos de ViraxImmune鈩�, centrados en el perfil inmunitario en s铆ndromes postvirales, especialmente el long COVID (PASC).
La compa帽铆a se est谩 preparando para una reuni贸n de pre-sumisi贸n con la FDA a principios de septiembre de 2025 para debatir la v铆a regulatoria y el uso previsto de ViraxImmune鈩�. El Laboratory for Innovative Assay Development (ELIAD) de Emory se encargar谩 del reclutamiento de pacientes, las pruebas y el an谩lisis para generar datos cl铆nicos que respalden las solicitudes regulatorias.
ViraxImmune鈩� es una tecnolog铆a de prueba de c茅lulas T que eval煤a los perfiles de respuesta inmune de los pacientes, ofreciendo ventajas potenciales frente a las pruebas de anticuerpos tradicionales para el diagn贸stico de condiciones cr贸nicas y postvirales.
Virax Biolabs (NASDAQ:VRAX)电� 鞐愲毽� 雽�頃欔祼鞚� ADJUST 靹柬劙鞕� 鞐瓣惮 靹滊箘鞀� 瓿勳暯(Research Services Agreement)鞚� 觳搓舶頃橃棳 ViraxImmune鈩㈧棎 雽�頃� 鞛勳儊 鞐瓣惮毳� 歆勴枆頃╇媹雼�. 鞐瓣惮电� 欤茧 鞛リ赴 旖旊雮�(鞛リ赴 頉勳湢歃�, PASC)毳� 韽暔頃� 氚旍澊霟姢 鞚错泟 歃濏泟甑办潣 氅挫棴 頂勲韺岇澕毵侅棎 欷戩爯鞚� 霊‰媹雼�.
須岇偓电� ViraxImmune鈩㈧潣 攴滌牅 瓴诫鞕� 靷毄 氇╈爜鞚� 雲检潣頃橁赴 鞙勴暣 2025雲� 9鞗� 齑� FDA鞕�鞚� 靷爠 鞝滌稖 須岇潣鞚� 欷�牍勴晿瓿� 鞛堨姷雼堧嫟. 鞐愲毽潣 Laboratory for Innovative Assay Development(ELIAD)鞚� 頇橃瀽 氇, 瓴�靷� 氚� 攵勳劃鞚� 雼措嫻頃橃棳 攴滌牅 鞝滌稖鞚� 歆�鞗愴暊 鞛勳儊 雿办澊韯半ゼ 靸濎劚頃� 鞓堨爼鞛呺媹雼�.
ViraxImmune鈩⒌鐢 頇橃瀽鞚� 氅挫棴 氚橃潙 頂勲韺岇澕鞚� 韽夑皜頃樀鐢 T靹疙彫 瓴�靷� 旮办垹搿�, 毵岇劚 氚� 氚旍澊霟姢 頉� 靸來儨 歆勲嫧鞐愳劀 旮办〈 頃泊 瓴�靷棎 牍勴暣 鞛犾灛鞝� 鞚挫爯鞚� 鞝滉车頃╇媹雼�.
Virax Biolabs (NASDAQ:VRAX) a conclu un Research Services Agreement avec le ADJUST Center de l'Emory University pour mener des 茅tudes cliniques sur ViraxImmune鈩�, en se concentrant sur le profilage immunitaire dans les syndromes post鈥憊iraux, en particulier le long COVID (PASC).
La soci茅t茅 se pr茅pare 脿 une r茅union de pr茅鈥憇oumission avec la FDA d茅but septembre 2025 afin de discuter de la voie r茅glementaire et de l'utilisation pr茅vue de ViraxImmune鈩�. Le Laboratory for Innovative Assay Development (ELIAD) d'Emory prendra en charge le recrutement des patients, les tests et les analyses pour g茅n茅rer des donn茅es cliniques soutenant les dossiers r茅glementaires.
ViraxImmune鈩� est une technologie de test des lymphocytes T qui 茅value les profils de r茅ponse immunitaire des patients, offrant des avantages potentiels par rapport aux tests d'anticorps traditionnels pour le diagnostic des affections chroniques et post鈥憊irales.
Virax Biolabs (NASDAQ:VRAX) hat eine Research Services Agreement mit dem ADJUST Center der Emory University abgeschlossen, um klinische Studien zu ViraxImmune鈩� durchzuf眉hren. Der Schwerpunkt liegt auf der Immunprofilierung bei postviralen Syndromen, insbesondere Long COVID (PASC).
Das Unternehmen bereitet ein Pre-Submission Meeting mit der FDA Anfang September 2025 vor, um den regulatorischen Weg und den beabsichtigten Einsatz von ViraxImmune鈩� zu besprechen. Emorys Laboratory for Innovative Assay Development (ELIAD) 眉bernimmt das Patientenrekrutierung, die Tests und die Analyse, um klinische Daten f眉r regulatorische Einreichungen zu erstellen.
ViraxImmune鈩� ist eine T鈥慫ell-Testtechnologie, die das Immunantwortprofil von Patienten bewertet und gegen眉ber herk枚mmlichen Antik枚rpertests potenzielle Vorteile bei der Diagnose chronischer und postviraler Erkrankungen bietet.
- Partnership with prestigious Emory University for clinical validation
- Advancing towards FDA regulatory pathway with pre-submission meeting
- Targeting large market opportunity in long COVID diagnostics
- Proprietary T cell testing technology offering advantages over conventional antibody tests
- No clinical validation data available yet
- FDA approval timeline uncertain
- Product still in development phase with no immediate revenue
Insights
Virax's Emory partnership and FDA meeting advance ViraxImmune鈩� toward clinical validation and regulatory approval for long COVID diagnostics.
This partnership with Emory University's ADJUST Center represents a significant milestone in Virax's clinical development strategy for ViraxImmune鈩�. The collaboration with a prestigious academic institution provides essential clinical validation infrastructure through the Emory Laboratory for Innovative Assay Development (ELIAD), which will handle critical components including patient recruitment, testing protocols, and data analysis.
The timing is particularly strategic, coming just before Virax's FDA pre-submission meeting in September 2025. This regulatory engagement will be pivotal in determining both the intended use parameters and the optimal regulatory pathway for ViraxImmune鈩� in post-acute sequelae of SARS-CoV-2 (PASC) applications. The FDA's feedback will directly shape the design of Virax's pivotal U.S. clinical trials鈥攁 critical step toward potential market authorization.
ViraxImmune鈩�'s T-cell testing approach offers a differentiated diagnostic solution compared to conventional antibody testing methods. By assessing T-cell reactivity rather than just antibody presence, the technology addresses a fundamental limitation in current diagnostic approaches for post-viral conditions, where antibody levels may not correlate with ongoing immune dysfunction or clinical symptoms.
The long COVID diagnostic market represents a substantial opportunity, with millions of affected individuals lacking effective diagnostic tools. This creates a significant unmet medical need that ViraxImmune鈩� could potentially address, assuming clinical studies generate supportive data and regulatory approval follows. The formalization of this research relationship, coupled with the impending FDA discussions, suggests Virax is executing a methodical approach to market entry in the specialized immune profiling diagnostic sector.
Under the agreement, the Emory Laboratory for Innovative Assay Development ("ELIAD") will conduct patient recruitment, testing, and analysis to generate clinical data. This data is intended to support Virax's planned regulatory submissions and potential future commercial rollout.
This collaboration aligns with Virax's preparations for a pre-submission meeting with the
"Partnering with Emory University, one of the foremost institutions in immunology and clinical research, is an important step toward validating ViraxImmune鈩� in real-world patient populations," said James Foster, Chief Executive Officer of Virax Biolabs. "With millions suffering from long COVID and other post-viral conditions without effective diagnostic options, we believe ViraxImmune鈩� is uniquely positioned to fill this gap. This collaboration advances our broader U.S. market entry strategy and represents a significant opportunity to create long-term value for our shareholders as we work to establish Virax as a leader in immune profiling diagnostics."
Dr. Wilbur A. Lam, MD, PhD, Professor of Pediatrics and Biomedical Engineering at Emory University and Georgia Tech, and Director of the ADJUST Center, commented: "PASC and other post-viral syndromes remain poorly understood and underdiagnosed. Immune profiling technologies could provide critical insights into patient immune function, enabling more precise diagnosis and potentially guiding treatment strategies."
ViraxImmune鈩� is a proprietary T cell testing technology designed to evaluate a patient's immune response profile. Unlike conventional antibody testing, it assesses T cell reactivity to provide a more comprehensive picture of immune health in chronic and post-viral conditions.
About Virax Biolabs Group Limited
Virax Biolabs Group Limited is an innovative biotechnology company focused on the detection of immune responses to and diagnosis of viral diseases. Virax Biolabs Group Limited is currently developing T cell-based test technologies with the intention of providing an immunology profiling platform. T cell testing can be particularly effective in the diagnosis and therapeutics of post-viral syndromes such as long COVID and other chronic conditions linked to immune dysregulation.
For more information, please visit .
About Emory University
Emory University is a leading research institution based in
Caution Concerning Forward Looking Statements:
This press release contains forward-looking statements. In addition, from time to time, we or our representatives may make forward-looking statements orally or in writing. We base these forward-looking statements on our expectations and projections about future events, which we derive from the information currently available to us. Such forward-looking statements relate to future events or our future performance, including: our financial performance and projections; our growth in revenue and earnings; and our business prospects and opportunities. You can identify forward-looking statements by those that are not historical in nature, particularly those that use terminology such as "may," "should," "expects," "anticipates," "contemplates," "estimates," "believes," "plans," "projected," "predicts," "potential," or "hopes" or the negative of these or similar terms. In evaluating these forward-looking statements, you should consider various factors, including: our ability to change the direction of the Company; our ability to keep pace with new technology and changing market needs; and the competitive environment of our business. These and other factors may cause our actual results to differ materially from any forward-looking statement. Forward-looking statements are only predictions. The forward-looking events discussed in this press release and other statements made from time to time by us or our representatives, may not occur, and actual events and results may differ materially and are subject to risks, uncertainties, and assumptions about us. These forward-looking statements are based on information currently available to Virax and its current plans or expectations and are subject to a number of known and unknown uncertainties, risks and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the "Risk Factors" section of Virax's Annual Report on Form 20-F for the year ended聽March 31, 2025. Although we believe the expectations reflected in such forward-looking statements are reasonable, we can give no assurance that such expectations will prove to be correct. We are not obligated to publicly update or revise any forward-looking statement, whether as a result of uncertainties and assumptions, the forward-looking events discussed in this press release and other statements made from time to time by us or our representatives might not occur.
View original content to download multimedia:
SOURCE Virax BioLabs Group Limited
FAQ
What is the purpose of Virax Biolabs' partnership with Emory University?
When is VRAX meeting with the FDA regarding ViraxImmune?
How does ViraxImmune differ from traditional COVID testing?
What is the market opportunity for VRAX's ViraxImmune technology?
Who will conduct the clinical studies for Virax Biolabs' ViraxImmune?
