bioLytical’s iStatis Syphilis Test Approved for Australian Market

bioLytical Laboratories Inc. has announced that its iStatis Syphilis Antibody Test is now officially listed on the Australian Register of Therapeutic Goods (ARTG: 515126). This development, confirmed on October 12, 2025, allows the rapid diagnostic tool to be distributed to healthcare professionals throughout Australia, enhancing the country’s capacity for prompt and reliable syphilis screening.

In a statement regarding this achievement, Robert Mackie, CEO of bioLytical, expressed enthusiasm about the test’s approval. “Australia, like many countries, continues to face rising syphilis rates, particularly in regions with limited access to regular healthcare,” he noted. The introduction of the iStatis test aims to facilitate earlier identification of infections and expedite treatment for affected individuals.

Enhancing Diagnostic Accessibility

The iStatis Syphilis Antibody Test is a lateral flow assay that detects antibodies to Treponema pallidum, the bacterium responsible for syphilis. Utilizing a simple fingerstick blood sample, the test generates results in under 15 minutes, which can be crucial for timely clinical decisions.

The significance of rapid testing in public health cannot be overstated. As noted by Ana Subramanian, Vice President of Scientific Affairs at bioLytical, “Every congenital case of syphilis is preventable with timely testing and treatment.” The accessibility of such rapid diagnostic solutions is vital in expanding early diagnosis across both clinical and outreach environments, ultimately safeguarding maternal and infant health.

Supporting Australia’s Public Health Strategy

The ARTG inclusion of the iStatis Syphilis Antibody Test aligns with Australia’s national strategy to enhance testing capabilities and reduce sexually transmitted infections. By delivering fast and reliable diagnostics, bioLytical aims to bolster early detection, accelerate treatment responses, and prevent further transmission, particularly in underserved or remote areas.

Manufactured in Canada in compliance with bioLytical’s MDSAP and ISO 13485:2016-certified Quality Management System, the iStatis Syphilis Antibody Test is part of a growing portfolio of rapid diagnostic solutions offered by the company. These products are designed to provide real-time, accurate results that enhance patient outcomes and contribute to global public health objectives.

Healthcare professionals in Australia can acquire the iStatis Syphilis Antibody Test through authorized distributors or by contacting bioLytical directly for further information. The company’s commitment to advancing healthcare through innovative diagnostics continues to position it as a key player in addressing critical health challenges worldwide.

For more details, visit bioLytical’s official websites at www.biolytical.com, www.insti.com, and www.istatis.com.