Global Fund approval for HIV diagnostic

Burnet Institute

20 November, 2019

In the lead-up to World AIDS Day, Burnet Institute is showcasing our latest successes and initiatives in the HIV field …

Today we can announce that a simple, low-cost, rapid HIV diagnostic developed by Burnet and commercialised by our partners at Omega Diagnostics, UK, has been endorsed by the Expert Review Panel for Diagnostics (ERPD), hosted by the Global Fund to Fight AIDS, Tuberculosis and Malaria.

This means that the test may be procured with Global Fund and/or UNITAID funds, which support major aid agencies operating in many of the poorest countries in the world.

While most countries now have policies that allow all HIV-infected patients to receive life-saving antiretroviral therapy regardless of their CD4 T-cell count, the VISITECT® CD4 Advanced Disease test can identify whether that person already has advanced HIV disease (a CD4 T-cell count below 200) when they are first diagnosed with HIV infection.

For these patients, who represent the majority of new HIV diagnoses in many resource-poor countries, a package of additional, urgent interventions are needed to address the risks of AIDS complications that often result in death before the antiretrovirals can stabilize the patient’s immune system.

These interventions are widely available, but their effective use relies on first determining the patient’s CD4 count.

Burnet Institute Deputy Director and Co-Head, Global Health Diagnostics Development, Associate Professor David Anderson, said the ERDP’s validation is hugely significant.

“It gives the green light for the aid agencies delivering HIV care to tens of millions of people in disadvantaged communities around the world to take advantage of this innovation,” Associate Professor Anderson said.

“The problem this addresses is that many patients are already suffering what we would have called full-blown AIDS when they are first diagnosed with HIV.

“This test allows us to see who’s already really sick and needs additional interventions and advanced care, versus those who are still relatively healthy and whose immune system hasn’t suffered too much.”

Associate Professor Anderson said the opportunity to make the VISITECT® CD4 Advanced Disease test available globally to the people who need it most represents the culmination of more than a decade’s research and development by Burnet and project partner, Omega Diagnostics.

“Our aim was to make something that could be used anywhere by a minimally trained healthcare worker, and it’s the only true point of care test for measuring CD4 T-cells, without the need for any instrumentation” he said.

“Clinical trials have shown that the visual result of this test can be read by eye to give the right result in the vast majority of cases, so that no matter where or when you’re diagnosed with HIV, no matter where your health care system is, you’re able to get the appropriate level of care.”

Associate Professor Anderson said the work put into VISITECT® CD4 Advanced Disease test has helped to inform new projects, including the development of a plasma separator to assist in measuring HIV viral load in patients on therapy, and a diagnostic test under development for sepsis.

“So it really has been leveraged for a lot of other activity and innovation since we started work on it,” he said.

“It was a very challenging problem, but by solving those hard problems, it’s given us a real head start on some others.”

Find out more about Burnet’s HIV projects and how you can support our life-saving work.

Contact Details

For more information in relation to this news article, please contact:

Associate Professor David Anderson

Deputy Director (Partnerships), Burnet Institute; Chief Scientific Officer, Burnet Diagnostics Initiative




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