• The INSTI Hepatitis C (HCV) Antibody Test is authorized by Health Canada for immediate entry into the Canadian market
• The screening test is portable and can be used as an aid in diagnosis for detection of antibodies to the Hepatitis C virus (HCV)
• High accuracy was demonstrated in clinical studies, with industry-leading sensitivity and specificity
• bioLytical's Quality Management system is MDSAP/ISO 13485:2016 certified

RICHMOND, British Columbia, Nov. 04, 2024 (GLOBE NEWSWIRE) -- bioLytical Laboratories Inc. ("bioLytical"), a global leader in rapid diagnostic tests, proudly announces that it has received Health Canada authorization for its INSTI® HCV Antibody Test for professional use in Canada. This allows the company to immediately enter the Canadian marketplace, offering healthcare professionals more options to screen their patients for hepatitis C quickly and accurately.

Hepatitis C is a liver infection caused by the hepatitis C virus (HCV). It is considered a sexually transmitted and blood-borne infection (STBBI) as it can be transmitted through sexual or blood contact and is spread primarily through blood. As a curable disease, regular access to rapid testing plays a crucial role in ending hepatitis C as a public health threat.

"We are thrilled to receive Health Canada authorization for our INSTI® HCV Antibody Test,” said Robert Mackie, CEO of bioLytical. "This approval underscores our dedication to bringing innovative, high-quality diagnostic tools to healthcare providers across Canada. With hepatitis C posing a significant public health challenge, our rapid test will help professionals diagnose more patients quickly and accurately, which is critical in the fight to eliminate hepatitis C in Canada.”

Key features of the INSTI® HCV Antibody Test include:

• Rapid: Provides results in one minute or less, facilitating quick triage and access to treatment
• Easy to Use: Simple finger prick procedure requiring minimal training
• Portable and Stable: Suitable for various environments, including clinics and emergency settings
• High-Quality Manufacturing: Meets rigorous standards with 97.15% sensitivity and 99.47% specificity in detecting HCV antibodies

Hepatitis C remains a pressing health concern in Canada, with an estimated 250,000 Canadians living with the virus, many of whom are undiagnosed. Early detection is crucial, as approximately 44% of individuals infected with hepatitis C in Canada are unaware of their status, increasing the risk of transmission and delaying access to treatment. Introducing the INSTI® HCV Antibody Test to the Canadian market provides a powerful tool for healthcare providers to screen patients more efficiently, facilitating timely treatment and reducing the spread of the virus.

Consistent access to rapid testing is crucial for eliminating hepatitis C as a public health threat. The INSTI® platform, with its innovative approach, serves as an ideal first-line assay for hepatitis C antibody detection, providing highly accurate results in just one minute. Regular testing is essential for promptly identifying potential hepatitis C infections, enabling quick connections to care and reducing the risk of onward transmission. The INSTI® HCV Antibody Test addresses a critical clinical need by eliminating the need for venepuncture, minimizing treatment delays, and enhancing patient follow-up care.

"Adding our INSTI® HCV Antibody Test to the diagnostic arsenal available in Canada is a significant step toward achieving our goal of eliminating hepatitis C as a public health threat,” Mackie added. "By providing healthcare professionals with a fast, accurate, and easy-to-use test, we are helping to ensure that more Canadians know their status and can take proactive steps to protect their health and the health of others.”

This milestone aligns with Canada's broader public health goals, emphasizing the importance of regular and widespread hepatitis C testing as a key strategy to reduce infection rates. With the INSTI® HCV 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 hepatitis C in Canada.

bioLytical will manufacture the INSTI® HCV Antibody Test in its MDSAP/ISO 13485-certified facility in Richmond, B.C. to sell and distribute across Canada. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is working to ensure our test kits are available nationwide so all Canadians can know their status.

For more information, please visit bioLytical's website.

Media Contact:

Stephanie Ritchie, Communications Specialist, bioLytical

press@biolytical.com

+1-778-238-9340

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, and 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:

Canadian Liver Foundation: https://www.liver.ca/patients-caregivers/liver-diseases/hepatitis-c/

Public Health Agency of Canada: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/hepatitis-c-screening-testing-health-professionals.html

Public Health Agency of Canada: https://www.canada.ca/en/public-health/services/diseases/hepatitis-c.html

A photo accompanying this announcement is available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/87198011-5a80-4b38-9aaa-dbdce8c7e5fc

A video accompanying this announcement is available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/a04321da-bb6e-4a80-9e88-60a77fa01728