Health Canada Authorizes bioLytical’s iStatis Syphilis Test, Boosting Rapid Response to Rising Infections in Canada

Now authorized for professional use in Canada, the iStatis Syphilis Antibody Test offers a fast, accurate, and portable solution to strengthen syphilis screening efforts nationwide.

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• Health Canada authorizes the iStatis Syphilis Antibody Test for professional use, delivering reliable results in under 15 minutes

• Enables rapid, accurate screening in both clinics and outreach programs

• Backed by bioLytical’s MDSAP: ISO 13485:2016-certified quality system, with high sensitivity and specificity

• Addresses growing need for fast syphilis testing amid rising national infection rates

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Richmond, B.C., Canada, July 22, 2025 - bioLytical Laboratories Inc. (“bioLytical”), a global leader in rapid diagnostics, has received Health Canada authorization of its iStatis Syphilis Antibody Test. This milestone allows for immediate distribution across Canada, providing healthcare professionals with a powerful tool to screen for syphilis quickly and accurately in clinical and community settings.

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“We are honoured to receive Health Canada authorization for our iStatis Syphilis Antibody Test,” said Robert Mackie, CEO of bioLytical. “ With syphilis rates rising in communities across Canada, it’s more important than ever to equip healthcare professionals with fast, reliable tools. This authorization strengthens our ability to support Canada’s public health efforts with timely, accurate testing.”

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Fast, Accurate, and Designed for Real-World Use

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The iStatis Syphilis Antibody Test is a lateral flow assay that detects antibodies to Treponema pallidum, the bacterium that causes syphilis. Designed for use by healthcare professionals, the test aids in diagnosis through a simple, fingerstick blood sample.

Key Benefits:

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• Rapid Results: Same visit results in under 15 minutes

• High Accuracy: Demonstrated excellent sensitivity and specificity in clinical trials

• Practical Design: Portable and room-temperature stable, ideal for outreach programs, clinics, or remote settings

• Simple Procedure: Requires only a small blood sample from a finger prick, with no complex lab equipment needed

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Strengthening Canada’s Public Health Priorities

With rising rates across both urban and rural communities, particularly among populations with limited access to regular healthcare, expanding access to reliable syphilis testing is essential to achieving Canada’s sexually transmitted and blood-borne infections (STBBI) strategy goals.

“The availability of a rapid syphilis antibody test capable of detecting the infection at different clinical stages is a significant advancement,” said Ana Subramanian, Vice President, Scientific Affairs at bioLytical. “The iStatis platform supports earlier diagnosis and treatment, especially in high-burden regions where immediate screening is essential.”

Early detection remains one of the most effective tools in controlling the spread of syphilis. Because many infections can go undiagnosed due to mild or hidden symptoms, people may unknowingly transmit the infection to others. The introduction of the iStatis Syphilis Antibody Test provides Canadian healthcare providers with a powerful first-line testing option to identify infections earlier, initiate timely treatment, and help reduce the overall burden of syphilis nationwide.

Addressing the Rise of Congenital Syphilis

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Canada is also experiencing a sharp increase in congenital syphilis, a preventable infection passed from parent to child during pregnancy. While reported cases have dropped from 2022, the Public Health Agency of Canada (PHAC) advises rates have increased drastically from 2018 by 220%.

If left undiagnosed, congenital syphilis can lead to serious outcomes, including miscarriage, stillbirth, low birth weight, and long-term complications. Early testing during pregnancy is vital to prevent transmission and protect maternal and infant health.

“Every case of congenital syphilis is preventable with early diagnosis and treatment,” said Ana Subramanian. “Rapid tests like the iStatis Syphilis Antibody Test help providers act quickly and support safer outcomes for both parent and child. Expanding access to point-of-care testing is an important step toward closing prenatal care gaps and reducing congenital infections in Canada.”

Made in Canada, Available Coast-to-Coast

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This milestone aligns with Canada's broader public health goals, emphasizing the importance of regular and widespread syphilis testing as a key strategy to reduce infection rates. With the iStatis Syphilis Antibody Test now available for professional use, bioLytical is committed to supporting healthcare providers nationwide in screening at-risk populations, connecting patients to care, and ultimately reducing the burden of syphilis in Canada.

bioLytical will manufacture the iStatis Syphilis Antibody Test at its Richmond, B.C. headquarters, in full compliance with MDSAP and ISO 13485:2016 standards. It is available nationwide through healthcare facilities, public health programs, and community-based organizations.

As a Canadian company with a global reach, bioLytical is committed to equipping healthcare providers with the tools they need to respond quickly and effectively to evolving public health challenges.

Media Contact:

Stephanie Ritchie, Communications Specialist, bioLytical

press@biolytical.com

+1-778-238-9340

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Sources:

• Government of Canada: Infectious Syphilis and Congenital Syphilis in Canada, 2023

• Canadian Guidelines on Sexually Transmitted Infections

• World Health Organization: Syphilis Fact Sheet