Milestone for HIV diagnostic

Burnet Institute warmly welcomes Nigeria’s approval of a Burnet-developed diagnostic for adoption in the National HIV Control Program.

The Omega VISITECT® CD4 350 test is a simple, low-cost rapid HIV diagnostic that can identify whether a person has reduced levels of CD4 T-cells during the course of HIV infection, which indicates that they should be prioritised for antiviral treatment.

Burnet’s commercial partner in the project, Omega Diagnostics, UK, is preparing to fulfill the first significant purchase orders of VISITECT® CD4 350 tests following extensive testing at sites across Nigeria.

Burnet Institute Deputy Director (Partnerships) and Head, Global Health Diagnostics Development, Associate Professor David Anderson said it’s a significant milestone in a long and exacting development process.

“It’s extremely satisfying that, 14 years after we started this project, we have a test that will allow significant numbers of patients in places where they don’t have access to laboratories to get a CD4 count to help the management of their HIV disease,” Associate Professor Anderson said.

“We’re really heartened by that, and grateful for the hard work by Omega Diagnostics in bringing our innovation through to a commercial reality, and in getting it accepted by the relevant regulatory authorities and by the Nigerian Ministry of Health so that it can actually help patients, which was always the goal.”

Colin King, CEO of Omega commented: “I am pleased that our test has been approved for use in Nigeria which was one of our key strategic aims and allows our unique point-of-care test to make a real difference to people living with HIV in Nigeria.”

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 350 can identify whether that person already has reduced T-cell counts (a CD4 T-cell count below 350) which makes treatment an urgent priority.

The approval and first sales of the VISITECT® CD4 350 test complement the recent endorsement of the Expert Review Panel for Diagnostics (ERPD) for major aid agencies to use funding from UNITAID and/or Global Fund to Fight AIDS, Tuberculosis and Malaria to procure the VISITECT® CD4 Advanced Disease test.

That test, which uses the same Burnet technology, identifies whether a person has a CD4 T-cell count below 200.

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

“Our aim was to make something that could be used anywhere by a minimally trained healthcare worker, and these are the only true point of care tests for measuring CD4 T-cells, without the need for any instrumentation,” Associate Professor Anderson said.

“What we’ve developed together with Omega is fit for purpose in those settings, and that’s exactly why we designed it that way.”

Find out more about Burnet’s work in Global Health Diagnostics.

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