Health Canada Authorizes North America’s First Hepatitis B Rapid Test, bioLytical’s iStatis Hepatitis B Surface Antigen Test

bioLytical’s iStatis test delivers results in 15 minutes in clinical and community settings

A Critical Step in Hepatitis B Diagnosis and Prevention in Canada

• bioLytical’s iStatis Hepatitis Surface Antigen Test (iStatis HBsAg Test) has received Health Canada authorization for use as a Point-of-Care Test (POCT)
• The first Health Canada-authorized point-of-care test for hepatitis B surface antigen and the first of its kind in North America
• Enables detection of the hepatitis B surface antigen with high sensitivity and specificity
• Portable and accurate; ideal for clinics, outreach settings, and community-based care
• Expanded access supports Canada’s public health goals and the WHO target to eliminate viral hepatitis as a public health threat by 2030

Canada Approves First Rapid Point-of-Care Test for Hepatitis B

RICHMOND, British Columbia, May 05, 2026 (GLOBE NEWSWIRE) — Canada has authorized its first rapid point-of-care test for hepatitis B, marking a North American first and a significant step toward improving access to screening and early diagnosis.

Developed by bioLytical Laboratories Inc., the iStatis Hepatitis B Surface Antigen (HBsAg) Test delivers results in 15 minutes and is designed for use in clinics, mobile units, outreach programs, and community-based settings where traditional lab testing may be less accessible.

The approval comes as hepatitis B remains a major but underdiagnosed public health issue in Canada. More than 260,000 Canadians are living with chronic hepatitis B, yet nearly half are unaware of their infection status, according to public health estimates.

Addressing Gaps in Hepatitis B Diagnosis

Limited access to timely testing continues to be a barrier, particularly in remote, underserved, and high-risk communities. Rapid point-of-care testing allows healthcare providers to screen and deliver results during a single visit, helping connect patients to care sooner.

“Too many people with hepatitis B remain undiagnosed because testing isn’t always accessible,” said Robert Mackie, CEO of bioLytical Laboratories. “This authorization allows screening to move closer to the patient, whether that’s in a clinic, a mobile unit, or a community outreach setting.”

The iStatis HBsAg Test detects the hepatitis B surface antigen, a marker of active infection, enabling healthcare providers to make informed decisions quickly and initiate follow-up care where needed.

A Tool for Frontline and Community-Based Care

Designed for decentralized use, the test requires minimal training and no additional instrumentation. Its portability and ease of use make it suitable for a wide range of care environments, including harm reduction services and community health programs.

“Rapid, reliable screening at the point of care can make a meaningful difference in how quickly patients are diagnosed and linked to treatment,” said Dan Wang, Director of Scientific Affairs at bioLytical. “This test brings accurate hepatitis B screening directly to frontline healthcare providers.”

Supporting Public Health Goals

The iStatis platform helps advance Canada’s public health goals by:

• Supporting national hepatitis elimination efforts aligned with WHO 2030 targets
• Expanding access to testing for priority and underserved populations
• Enabling earlier diagnosis, treatment, and prevention through point-of-care screening

bioLytical’s Commitment to Excellence

bioLytical will manufacture the iStatis HBsAg Test in its Canadian facility under its ISO 13485:2016 and MDSAP-certified Quality Management System. With over two decades of experience in rapid diagnostics, bioLytical continues to develop innovative tests that support local and global health priorities.

For more information, visit www.biolytical.com or contact:

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 iStatis lateral flow line. By delivering accurate, real-time results, INSTI^® and iStatis generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide, making bioLytical a key partner in tackling some of the world’s most pressing healthcare challenges.

Sources:

• Canada’s progress towards eliminating viral hepatitis as a public health concern
• WHO: Global Health Sector Strategy on Viral Hepatitis 2022–2030
• CCDR: Canada National Hepatitis B and C Estimates for 2021 (Volume 51-6/7, June/July 2025)

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/8c4f4c4f-8565-4ee5-9842-ca4d0dcf67fb

Media Contact:

Alan Rodrigues
Marketing Manager, bioLytical
press@biolytical.com

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