Key Points
- The iStatis Syphilis Antibody Test is now listed on the Australian Therapeutic Goods Register (ARTG: 515126), available for professional use nationwide.
- Provides accurate results in less than 15 minutes, allowing screening in a variety of healthcare settings.
- Manufactured according to bioLytical's MDSAP quality management system, certified to ISO 13485:2016.
- Designed to support Australia's ongoing efforts to reduce syphilis transmission and improve early diagnosis.
- Portable, reliable and stable at room temperature, suitable for both laboratory and remote use.
RICHMOND, British Columbia, Oct. 12, 2025 (GLOBE NEWSWIRE) — bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid diagnostic solutions, announces the inclusion of its Thus, a test for antibodies to syphilis V Australian Therapeutic Goods Register (ARTG: 515126). This important development will enable the test to be rolled out to healthcare providers across Australia, strengthening the nation's capacity to screen for syphilis quickly and reliably.
“We are pleased to announce that our iStatis syphilis antibody test is now included in ARTG,” said Robert Mackie, CEO of bioLytical. “Australia, like many countries, continues to see rising rates of syphilis, particularly in areas with limited access to routine healthcare. By providing an accurate and easy-to-use rapid test, we can help healthcare providers identify infections earlier and refer patients to treatment more quickly.”
Fast, accurate and affordable
The iStatis Syphilis Antibody Test is a lateral flow test that detects antibodies to Treponema pallidum, the bacterium that causes syphilis. Using a small finger prick blood sample, it provides results in less than 15 minutes, helping healthcare providers make timely clinical decisions.
Key Benefits
- Quick results: Reliable results in one visit in less than 15 minutes.
- High precision: Demonstrated high sensitivity and specificity in clinical studies.
- Portable Design: Stored at room temperature and can be used in field or clinical settings.
- Ease of use: Only a finger prick blood sample is required; no sophisticated equipment or cold storage is required.
Why rapid testing for syphilis is important
- There were 5866 syphilis diagnoses across Australia in 2024, roughly double the number 10 years earlier.
- Since 2015, the number of cases of congenital syphilis has more than doubled, with the disease causing 34 child deaths over the past decade.
- National reports from the Department of Health and Aged Care confirm that the number of infectious syphilis notifications continues to increase in all jurisdictions.
- Syphilis remains a nationally notifiable disease under the National Disease Surveillance System (NNDSS).
- Because early infections are often asymptomatic, affordable point-of-care testing is important for early detection and prevention.
Supporting Australian public health goals
The inclusion of the iStatis Syphilis Antibody Test in the ARTG supports Australia's national strategy to increase testing and reduce sexually transmitted infections. Providing fast and reliable diagnostics, bioLytical's goal is to enhance early detection, speed treatment and prevent transmission, especially in underserved or remote areas.
“Every congenital case of syphilis is preventable with timely screening and treatment,” said Ana Subramanian, vice president of scientific affairs at bioLytical Laboratories. “Rapid point-of-care solutions like the iStatis Syphilis Antibody Test are critical to expanding access to early diagnosis in both clinical and community settings, helping to protect the health of mothers and children around the world.”
Manufactured in Canada under bioLytical's MDSAP and ISO 13485:2016 certified quality management system, the iStatis Syphilis Antibody Test is part of the growing iStatis company.® express diagnostics portfolio. Each test is designed to provide accurate, real-time results that improve patient outcomes and advance global public health goals.
Healthcare professionals across Australia can access the test through authorized distributors or by contacting bioLytical directly.
For more information visit bioLytical website.
About bioLytical Laboratories Inc.:
bioLytical Laboratories Inc. is a private Canadian company engaged in the research, development and commercialization of rapid medical diagnostics using INSTI's proprietary proprietary technology.® technology platform and its sideline iStatis. Providing accurate results in real time, INSTI® and iStatis deliver meaningful results for healthcare professionals, patients and public health organizations around the world. We are key partners in solving some of the world's most pressing health challenges. Visit www.biolytical.com, www.insti.com and www.istatis.com for more information.
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