bioLytical Launches iStatis Syphilis Test in Australia’s Health Market

bioLytical Laboratories Inc. has announced the inclusion of its iStatis Syphilis Antibody Test in the Australian Register of Therapeutic Goods, identified as ARTG: 515126. This development allows the distribution of the test throughout Australia, enhancing the capacity for rapid and reliable syphilis screening across the nation.

CEO of bioLytical, Robert Mackie, expressed enthusiasm about this milestone, highlighting the significance of addressing rising syphilis rates in Australia. He noted, “By providing an accurate, easy-to-use rapid test, we can support healthcare professionals in identifying infections earlier and connecting patients to treatment faster.” The test is particularly crucial in areas with limited access to regular healthcare services.

Details of the iStatis Syphilis Antibody Test

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

The rapid nature of this testing is vital for public health, particularly in light of Australia’s national strategy to combat sexually transmitted infections. By ensuring fast and reliable diagnostics, bioLytical aims to enhance early detection efforts, expedite treatment, and reduce transmission rates, especially in underserved and remote regions.

Ana Subramanian, Vice President of Scientific Affairs at bioLytical, emphasized the importance of timely testing, stating, “Every congenital case of syphilis is preventable with timely testing and treatment.” She noted that rapid, point-of-care solutions like the iStatis Syphilis Antibody Test are essential for expanding access to early diagnosis in both clinical and outreach settings, ultimately protecting maternal and infant health globally.

Manufacturing and Distribution

Manufactured in Canada, the iStatis Syphilis Antibody Test adheres to bioLytical’s MDSAP and ISO 13485:2016-certified Quality Management System. This product is part of the expanding iStatis® portfolio of rapid diagnostics, which aims to provide real-time, accurate results that improve patient outcomes and further global public health goals.

Healthcare professionals across Australia can access the iStatis Syphilis Antibody Test through authorized distributors or by contacting bioLytical directly. For further information, interested parties can visit bioLytical’s official website.

About bioLytical Laboratories Inc.: Established as a privately owned Canadian company, bioLytical focuses on researching, developing, and commercializing rapid medical diagnostics. Their proprietary INSTI® technology platform and lateral flow line, iStatis, deliver accurate results in real-time, contributing to meaningful outcomes for medical professionals, patients, and public health organizations worldwide. For additional details about their offerings, please visit www.biolytical.com, www.insti.com, and www.istatis.com.