bioLytical’s iStatis Syphilis Antibody Test Now Included in the Australian Register of Therapeutic Goods (ARTG)

Expanding access to fast, accurate syphilis testing to support Australia’s public health response.

Key Highlights

The iStatis Syphilis Antibody Test is now included in the Australian Register of Therapeutic Goods (ARTG: 515126), available for professional use nationwide.
Delivers accurate results in under 15 minutes, enabling screening in various healthcare settings.
Manufactured under bioLytical’s MDSAP ISO 13485:2016-certified Quality Management System.
Designed to support Australia’s ongoing efforts to reduce syphilis transmission and improve early diagnosis.
Portable, reliable, and room-temperature stable 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 iStatis Syphilis Antibody Test in the Australian Register of Therapeutic Goods (ARTG: 515126). This milestone enables the distribution of the test to healthcare professionals across Australia, strengthening national capacity for fast and reliable syphilis screening.

“We are excited to announce that our iStatis Syphilis Antibody Test is now included in the ARTG,” said Robert Mackie, CEO of bioLytical. “Australia, like many countries, continues to face rising syphilis rates, particularly in regions with limited access to regular healthcare. 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, Accurate, and Built for Accessibility

The iStatis Syphilis Antibody Test is a lateral flow assay that detects antibodies to Treponema pallidum, the bacterium that causes syphilis. Using a small fingerstick blood sample, it provides results in under 15 minutes, helping healthcare providers make timely clinical decisions.

Key Benefits

Rapid Results: Reliable, same-visit results in less than 15 minutes.
High Accuracy: Demonstrated strong sensitivity and specificity in clinical trials.
Portable Design: Shelf-stable at room temperature for use in outreach or clinical settings.
Ease of Use: Requires only a fingerstick blood sample; no complex equipment or cold storage required.

Why Rapid Syphilis Testing Matters

In 2024, 5,866 syphilis diagnoses were recorded across Australia, roughly double the number from 10 years ago
Congenital syphilis cases have more than doubled since 2015, with 34 infant deaths attributed to the disease in the past decade
The Department of Health and Aged Care’s national syphilis surveillance reports confirm that infectious syphilis notifications continue to rise across jurisdictions
Syphilis remains a nationally notifiable disease under the National Disease Surveillance System (NNDSS)
Because early infections are often asymptomatic, accessible point-of-care testing is essential for early detection and prevention.

Supporting Australia’s Public Health Goals

The inclusion of the iStatis Syphilis Antibody Test in the ARTG supports Australia’s national strategy to expand testing and reduce sexually transmitted infections. By providing fast, reliable diagnostics, bioLytical aims to strengthen early detection, accelerate treatment, and prevent transmission, particularly in underserved or remote regions.

“ Every congenital case of syphilis is preventable with timely testing 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 for expanding access to early diagnosis in both clinical and outreach settings, helping to protect maternal and infant health worldwide."

Manufactured in Canada under bioLytical’s MDSAP and ISO 13485:2016-certified Quality Management System, the iStatis Syphilis Antibody Test is part of the company’s growing iStatis^® portfolio of rapid diagnostics. Each test is designed to deliver real-time, accurate 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, please visit bioLytical’s website.

About bioLytical Laboratories Inc.:
bioLytical Laboratories Inc. is a privately owned Canadian company focused on researching, developing, and commercializing rapid medical diagnostics using its proprietary INSTI^® technology platform and its lateral flow line, iStatis. By delivering accurate results in real-time, INSTI^® and iStatis generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide. We are key partners in tackling some of the world's most severe healthcare challenges. Please visit www.biolytical.com, www.insti.com, and www.istatis.com for more information.

Sources:

Kirby Institute (UNSW Sydney): Syphilis Data Portal
Australian Government Department of Health and Aged Care: National Syphilis Surveillance Quarterly Report (Oct–Dec 2024)
Australian Government Department of Health and Aged Care: National Response to Syphilis

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/7f7ba2ec-4a86-4b67-a0a0-55db1384146e

Media Contact:
Stephanie Ritchie, Communications Specialist, bioLytical
press@biolytical.com

iStatis Syphilis Antibody Test

iStatis Syphilis Antibody Test Pouch

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