Burnet, Atomo to jointly develop active syphilis self-test

Syphilis is a public health challenge globally, with the WHO estimating 8 million people acquired the infection in 2022. The Australian Government estimates 1 in 6 Australians will get a sexually transmissible infection (STI) in their lifetime.

Cases of infectious syphilis in Australia more than doubled between 2015 and 2020, with more than 6000 cases in the last 12 months.

People with syphilis may not have any symptoms. Infections are treatable, but early detection is essential, as it can have serious health implications if not detected and treated, particularly for pregnant women and their babies. Regular testing is the only way to check if you have an STI, as many STIs have no symptoms.

Diagnosis of a current syphilis infection is difficult because antibodies persist in patients who have had a previously treated infection. Currently approved point of care syphilis tests cannot distinguish between active syphilis infection and past treated infections, according to the researchers.

To tackle this, Burnet Institute and Atomo Diagnostics are set to jointly develop an active syphilis point of care test, which has received $2.44 million from the Australian Government.

The lateral flow test uses a finger prick blood sample and a syphilis antibody assay, developed by Burnet, to detect active syphilis infection. The lateral flow test is housed in the AtomoRapidPascal cassette, which has an integrated lancet and buffer, allowing for both professional use and at-home self-testing.

The Burnet Active Syphilis test can specifically identify active syphilis infections and is claimed to be the first rapid syphilis test approved for self-test use in Australia.

The Burnet Scientific Director for Research Translation and an inventor of the technology, Professor Heidi Drummer, said the test could differentiate between current and prior treated infections.

“Our novel technology can distinguish a current infection from previously treated infection, which has been identified by the World Health Organization (WHO) as a key priority for the management of the global surge in syphilis infections,” she said.

Burnet Institute Director for the Office of Research Translation Jennifer Barnes said the partnership and funding would allow the team to accelerate the development of the test towards regulatory approval.

“We are delighted to be working with Atomo to rapidly develop and clinically validate this active syphilis test,” she said.

“Strong research partnerships with the diagnostics industry are vital to translating our research, so it is great to have an Australian-based partner in Atomo to co-develop this test and address an unmet need.”

The funding is part of the Australian Government’s Cooperative Research Centres Projects (CRC-P) grant scheme.

Image caption: Shuning Zheng, Professor Heidi Drummer and Elsie Williams examine the syphilis point of care test. Image: Supplied.