bioLytical Secures Approval for Rapid Syphilis Test in Australia

bioLytical Laboratories Inc. has announced that its iStatis Syphilis Antibody Test has been officially included in the Australian Register of Therapeutic Goods (ARTG) under the registration number 515126. This significant approval allows the company to distribute the test to healthcare professionals across Australia, enhancing the nation’s ability to screen for syphilis quickly and accurately.

On October 12, 2025, Robert Mackie, CEO of bioLytical, expressed enthusiasm about the approval, highlighting the ongoing challenges Australia faces with rising syphilis rates. He noted that the test is particularly crucial in regions where access to regular healthcare is limited. “By providing an accurate, easy-to-use rapid test, we can support healthcare professionals in identifying infections earlier and connecting patients to treatment faster,” Mackie stated.

Features of the iStatis Syphilis Antibody Test

The iStatis Syphilis Antibody Test employs a lateral flow assay method that detects antibodies to Treponema pallidum, the bacterium responsible for syphilis. Utilizing a small fingerstick blood sample, the test yields results in under 15 minutes, enabling healthcare providers to make timely clinical decisions.

The test’s rapid and reliable results are pivotal for public health strategies aimed at combating sexually transmitted infections (STIs) in Australia. The inclusion of this test aligns with national health objectives to broaden testing availability and drive down infection rates. “Every congenital case of syphilis is preventable with timely testing and treatment,” emphasized Ana Subramanian, Vice President of Scientific Affairs at bioLytical Laboratories.

Impact on Public Health Initiatives

The introduction of the iStatis Syphilis Antibody Test supports Australia’s commitment to enhancing early detection and treatment of syphilis, particularly in underserved communities. By facilitating rapid testing in both clinical and outreach environments, this innovation aims to protect maternal and infant health, reducing transmission rates effectively.

Manufactured in Canada under bioLytical’s compliance with MDSAP and ISO 13485:2016 certified Quality Management Systems, the iStatis Syphilis Antibody Test is part of a growing portfolio designed to improve patient outcomes. Healthcare professionals in Australia can obtain the test through authorized distributors or by reaching out directly to bioLytical.

For further details on the iStatis Syphilis Antibody Test and other products, visit bioLytical’s official websites, including www.biolytical.com and www.istatis.com. Through its innovative diagnostic solutions, bioLytical continues to play a vital role in addressing some of the most pressing healthcare challenges globally.