The forthcoming ViraxImmune is a predictive test that is positioned to turn the traditional clinical paradigm on its head.

By Chris Wolski

By its nature, clinical diagnostics is reactive. A patient presents with a set of symptoms, a test is administered to identify the cause, and, with the result, a course of treatment can be started.

Virax Biolabs is looking to turn that model on its head with a predictive test that will help clinicians make informed decisions on patient care. In essence, it’s taking the next step in enabling true precision medicine.

CLP recently spoke with James Foster, chief executive officer of Virax Biolabs, about the company’s forthcoming ViraxImmune solution, how it works and is improving testing access, the nature of predictive medicine, and when it will be available on the U.S. market.

Foster’s answers have been edited for clarity and length.

CLP: Virax Biolabs is developing a predictive test to measure patients’ T-Cell levels. What is the potential efficacy of the test?

James Foster: ViraxImmune aims to revolutionize health care by providing a comprehensive view of an individual’s T-cell immunity. For clinicians, it offers an advanced diagnostic tool that can detect early immune responses, potentially even before antibodies form. This helps in making informed decisions tailored to each patient’s unique immune profile. For patients, it offers the promise of early intervention, better monitoring, and more personalized treatment plans. The test is designed to seamlessly integrate into existing health care workflows, offering timely and accurate results.

CLP: I think what’s most intriguing about ViraxImmune is that it is a predictive test. This seems a real shift in the health care mindset, which is traditionally focused on reacting to a disease diagnosis. Can you talk through how a predictive test could upend the way we think of diagnostics?

Foster: Absolutely, ViraxImmune signifies a major paradigm shift in health care from a reactionary model to a predictive approach. Traditionally, diagnostics have focused on identifying diseases after symptoms appear. ViraxImmune, however, is designed to go beyond that: by measuring T-cell levels, it provides early insights into the body’s immune responses, thus enabling clinicians and patients to take pre-emptive actions.

ViraxImmune isn’t just about diagnosing; it’s about foreseeing. It aligns with the broader framework of predictive medicine, which aims to identify who could be at risk for certain conditions before they even manifest. By analyzing T-cell responses to specific pathogens, it may help indicate susceptibility to particular diseases or how well someone might respond to a vaccination, thereby providing a nuanced understanding of individual immune landscapes.

Moreover, this approach stands to change the way health care systems operate. It allows for more targeted medical interventions and resource allocation, reducing the long-term health care burden both economically and socially. Ultimately, ViraxImmune aims to play a pivotal role in transforming health care from simply treating diseases to preventing them and improving long-term outcomes for patients.

CLP: Are there specific pathogens you’re focusing on at this time?

Foster: Initially, ViraxImmune is focusing on SARS-CoV-2 assays, given the immediate global health need. However, the platform is designed to be versatile, with plans to develop tests for a wide array of viral and bacterial infections. We are keenly interested in pathogens that have a significant public health impact. In addition to prevalent viruses, our R&D is actively exploring tests for tropical and seasonal diseases. We’re also positioning ourselves to be highly adaptable to emerging challenges by developing assays for new variants of existing viruses and completely new viral threats.

CLP: Can you walk through how the test will be delivered? It’s my understanding that this could be both a clinician-administered or patient-administered test, correct? In terms of the latter, you’re also re-positioning health care to be more patient-centric with the patient making decisions based on the test results, or is this an overstatement?

Foster: The ViraxImmune test is designed for use in a laboratory environment but offers a large flexibility in how it can be accessed: it can be prescribed by clinicians like general practitioners, utilized within hospital settings, or directly ordered by clients via a dedicated mobile application. This approach offers a blend of professional oversight and consumer choice, making it a truly patient-centric model. While it empowers health care providers with a robust diagnostic tool, it also allows individuals to take proactive steps in understanding and managing their immune health.

CLP: How do clinical labs fit into the Virax testing continuum?

Foster: Clinical laboratories are critical to the Virax testing continuum by providing the infrastructure needed for accurate and rapid analysis. Their privileged relationship with patients is extremely important, because this direct interaction enhances the feedback loop between patients, health care providers, and diagnostic solutions. We have the capability to meet the demand for high-throughput, high-quality testing and our aim is to make ViraxImmune an integral part of this ecosystem, offering reliable, scalable solutions for immune monitoring.

CLP: Where are you in the development process? Do you have a target release date in the U.S.?

Foster: We’re at an exciting juncture in the development process of ViraxImmune. The recent opening of our new laboratory in Glasgow has significantly accelerated our R&D efforts and provided the necessary infrastructure to ensure consistent and scalable manufacturing. This enables us to expedite the development and delivery of high-quality tests to the market.

Furthermore, we have launched our first research use only (RUO) product for SARS-CoV-2. Following this we’ll be expanding our RUO product offerings to cover a broader range of diseases. This allows us to gather valuable data and feedback, setting the stage for broader clinical adoption.

Subsequently, our goal is to move these products into the in vitro diagnostic (IVD) category aimed at U.S., UK & EU markets. This transition will follow rigorous validation studies to ensure the tests meet regulatory requirements and offer the highest quality and reliability. Our comprehensive timeline and multi-stage strategy aim to provide health care professionals and patients with advanced diagnostic tools that are both predictive and precise.

Chris Wolski is chief editor of CLP.