Virax Biolabs Group Limited announced the initiation of a clinical study in the United Kingdom (NCT06731179) aimed at assessing the ViraxImmune? platform's performance in detecting T-cell dysfunction in post-acute infectious syndrome patients, including those with long COVID, post-treatment Lyme disease (PTLD), and Myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS). The study will enroll up to 160 participants, with first patient dosed anticipated in early First Quarter 2025, followed by initial data readout anticipated in First Quarter 2026.

Building on the progress of initiating UK-based clinical validation study, are also focusing on advancing U.S. regulatory and clinical development. To facilitate this, The company have begun discussions with renowned U.S. based clinical institutions to initiate studies to support IVD development. Additionally, activities have been initiated to submit a request for a formal meeting with the FDA through its pre-submission program, also known as Q-submission.

This will allow the company to receive formal written feedback from the FDA regarding ViraxImmune? IVD clinical development and regulatory plans in the U.S., including guidance on clinical validation and performance testing. The company anticipates receiving the FDA written feedback by Second Quarter of 2025, followed by the initiation of U.S. based clinical validation study.

In addition, as part of launch and commercialization plans for ViraxImmune? IVD platform, aim to establish strategic collaborations with CLIA laboratories in the U.S. to offer laboratory development tests (LDTs) for clinical studies to support the development of ViraxImmune? platform.

The company have initiated consulting activities in the U.S. with external partners to assist with market research and pricing activities needed for product placement of this launch. Alongside advancing the ViraxImmune? IVD platform, The company launched research-use-only (RUO) ImmuneSelect portfolio in Second Quarter of 2024.

ImmuneSelect is a commercially available suite of research-use-only (RUO) immune profiling solutions, including peptide pools, ELISpot kits, and recombinant antibodies. This enables researchers and drug developers to study T-cell activation, immune profiling, and immune.