BioLytical’s iStatis Syphilis Test Approved for Australian Market

bioLytical Laboratories Inc. has announced that its iStatis Syphilis Antibody Test is now officially included in the Australian Register of Therapeutic Goods (ARTG: 515126). This significant development will allow the test to be distributed to healthcare professionals throughout Australia, enhancing the country’s capacity for efficient and accurate syphilis screening.

On October 12, 2025, Robert Mackie, CEO of bioLytical, expressed enthusiasm about the inclusion, emphasizing its potential impact as Australia grapples with increasing syphilis rates. “Australia, like many countries, continues to face rising syphilis rates, particularly in regions with limited access to regular healthcare,” he stated. “By providing an accurate, easy-to-use rapid test, we can support healthcare professionals in identifying infections earlier and connecting patients to treatment faster.”

Fast Testing for Enhanced Public Health

The iStatis Syphilis Antibody Test is a lateral flow assay designed to detect antibodies to Treponema pallidum, the bacterium responsible for syphilis. The test requires only a small fingerstick blood sample and delivers results in under 15 minutes. Such rapid feedback enables healthcare providers to make prompt clinical decisions, which is crucial in managing and preventing the spread of syphilis.

This new testing capability aligns with Australia’s national strategy to enhance testing and reduce sexually transmitted infections. By facilitating quick and reliable diagnostics, bioLytical aims to bolster early detection, speed up treatment, and mitigate transmission, particularly in underprivileged or remote areas.

Supporting Maternal and Infant Health

The importance of rapid syphilis testing extends beyond individual diagnostics. According to Ana Subramanian, Vice President of Scientific Affairs at bioLytical Laboratories, “Every congenital case of syphilis is preventable with timely testing and treatment.” She highlighted that rapid, point-of-care solutions like the iStatis test are essential for expanding access to early diagnosis, safeguarding maternal and infant health globally.

Manufactured in Canada under bioLytical’s MDSAP and ISO 13485:2016-certified Quality Management System, the iStatis test is part of the company’s expanding portfolio of rapid diagnostics. Each test is crafted to deliver real-time, accurate results that contribute to improved patient outcomes and further public health objectives.

Healthcare professionals in Australia can obtain the test through authorized distributors or by contacting bioLytical directly. For additional details, interested parties are invited to visit the company’s website.

BioLytical Laboratories Inc. is a privately owned Canadian firm dedicated to the research, development, and commercialization of rapid medical diagnostics utilizing its proprietary INSTI technology platform and the iStatis lateral flow line. By delivering accurate results promptly, bioLytical aims to create meaningful outcomes for medical professionals, patients, and public health organizations worldwide.