bioLytical’s iStatis Syphilis Test Receives Approval in Australia

bioLytical Laboratories Inc. has announced the inclusion of its iStatis Syphilis Antibody Test in the Australian Register of Therapeutic Goods (ARTG: 515126) as of October 12, 2025. This approval opens the door for the distribution of the test to healthcare professionals throughout Australia, enhancing the country’s ability to conduct rapid and reliable syphilis screenings.

CEO Robert Mackie expressed enthusiasm about the announcement, highlighting the increasing syphilis rates in Australia, especially in areas with limited healthcare access. “By providing an accurate, easy-to-use rapid test, we can support healthcare professionals in identifying infections earlier and connecting patients to treatment faster,” he stated.

Fast and Accessible Testing Solution

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.

This rapid testing method aligns with Australia’s public health initiatives aimed at reducing sexually transmitted infections. The inclusion of the iStatis test supports efforts to expand testing capabilities, particularly in underserved and remote regions.

Ana Subramanian, Vice President of Scientific Affairs at bioLytical, emphasized the importance of timely testing and treatment in preventing congenital syphilis cases. “Every congenital case of syphilis is preventable with timely testing and treatment,” she remarked. The availability of rapid, point-of-care solutions like the iStatis test is critical for enhancing access to early diagnosis in both clinical and outreach settings, thereby protecting maternal and infant health.

Commitment to Quality and Impact

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

Healthcare professionals in Australia will be able to access the iStatis Syphilis Antibody Test through authorized distributors or directly from bioLytical. For additional information, interested parties can visit bioLytical’s website.

Founded in Richmond, British Columbia, bioLytical Laboratories Inc. is a privately owned company dedicated to researching, developing, and commercializing rapid medical diagnostics using its proprietary INSTI® technology platform and its iStatis line. By delivering accurate real-time results, bioLytical aims to generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide.

For further details on the company and its products, please visit www.biolytical.com, www.insti.com, and www.istatis.com.