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Virax Biolabs Preparing T-Cell Testing Platform to Provide Consumers With Immune Status Info


NEW YORK – Virax Biolabs, a London-based diagnostics development and distribution company, is moving further toward commercialization of its T-cell testing platform Virax Immune.

While the firm began with a focus on distributing other companies' products, particularly pharmaceuticals and nutraceuticals, it began developing its own in vitro diagnostics about three years ago, CEO James Foster said. That shift has culminated in a proprietary T-cell test that is intended to inform people about their immune status for a variety of infectious diseases.

The COVID-19 pandemic changed the firm's business significantly, providing it with near-term revenue largely from distribution deals for other manufacturers' COVID-19 tests. For instance, earlier this month the company said that an undisclosed test supplier received US Food and Drug Administration Emergency Use Authorization for an over-the-counter rapid antigen test for COVID-19, and that Virax will now be able to distribute the tests in the US.

This in turn has given Virax more opportunities to raise capital and generate a larger investor base, providing a path to further develop its own technology, Foster said. 

Virax also completed an initial public offering in July and raised an additional $3.8 million in a private placement in November, CFO Jason Davis said. That funding will allow the firm to get through the entirety of the R&D phase for its Virax Immune T-cell test, he added. 

The Virax Immune test requires a blood sample that is treated with the firm's novel peptide mix — a proprietary formula that serves as a proxy for a specific virus — and incubated overnight, said CSO Tomasz George. Then various activation markers are measured via intracellular staining and flow cytometry to determine the percentage of T cells that have been activated, which correlates to the level of immunity. Right now, the firm is conducting clinical trials in the EU to determine the threshold for protection, or what exact percentage indicates a certain level of protection from a virus, said George. Those clinical trials are expected to be completed by the end of Q1 2023, he added. 

Many people early in the COVID-19 pandemic were infected with SARS-CoV-2 and didn't realize it, and this test could provide longer-term verification of whether someone was sick and if they're still protected from the virus, he said. The test is also intended to provide more clarity on someone's risk if they were infected, George said. "We want to give people an idea as to what their threat from the virus would be and allow them to make informed decisions on social distancing, [personal protective equipment], vaccinations, and any other … decisions they would need to make based on whether there was a virus in their area." 

T-cell testing for COVID-19 has been of interest to multiple companies and researchers due to the potential to provide a more accurate picture of immunity. T-cell immune response lasts longer than SARS-CoV-2 antibodies, which often disappear after a couple of months. Earlier this year, Roche launched a T-cell test for SARS-CoV-2, and Mount Sinai researchers have developed their own T-cell test for the virus. Adaptive Biotechnologies, one of the leaders in the T-cell testing arena, also has a SARS-CoV-2 T-cell test, although it has recently scaled back commercialization of other tests in its T-Detect franchise, such as one for Lyme disease. 

Although Virax Immune started with a COVID-19-specific formula, the firm is adapting the technology for different viruses, which George said requires only a few small changes in the mixture. The goal is to create a suite of tests in the next year and change that suite based on the prevalence of a certain disease, he said. The firm is exploring tests for cytomegalovirus, hepatitis, influenza A, human papillomavirus, herpes, and Epstein-Barr virus, George said. 

Once the COVID-19 clinical trials are completed, Virax is aiming to get EU and UK regulatory approval concurrently and commercialize the technology in those countries, he said. The firm intends to partner with laboratories, pharmacy groups, and healthcare networks in the EU to deliver the test, he said. 

Foster said that the company will then potentially file a submission with the US FDA in the middle of next year, although it hasn't engaged with the agency yet. 

In the next year or so, the company plans to adapt the test for use at the point of care and is working to miniaturize the workflow and put it into a handheld diagnostic device, possibly using a microfluidics cartridge. George noted, however, that the team first wants to make sure it has a "valid and working laboratory test." 

He also noted healthcare groups and governments could use it to assess the effects of outbreaks and identify where future outbreaks could occur. By using the test to determine which communities or demographics are more vulnerable to certain diseases, governments and other stakeholders could prepare for outbreaks and prioritize uninfected patients for vaccinations, he said. 

Pharmaceutical companies and clinical research organizations could also use the technology as a prescreening method for potential clinical trial populations, he said. 

The test can be done on minimal laboratory equipment present in most labs and can be distributed globally, George emphasized, and the firm is looking to make it as widely available as possible. Foster added that flow cytometry technology is relatively "lab agnostic" and that Virax wanted to make sure the test was also amenable for use in underdeveloped regions.

The company is also developing a companion app that would allow patients to see their results and provide general suggestions to improve their immune systems, such as changes in diet, and could be used with other diagnostic tests as well. That app would be linked to a subscription model allowing people to get different tests each year depending on what viruses are prevalent in their area, George said. To determine disease and variant prevalence, the company plans to utilize epidemiological data from the Southern Hemisphere, similar to the way influenza vaccines are developed, he added.