bioLytical Laboratories Inc. announced today the immediate availability of its INSTI® HCV Antibody Test in the Australian market. 

• The INSTI Hepatitis C (HCV) Antibody Test is now included in the Australian Register of Therapeutic Goods (ARTG number: 448926)
• 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

 bioLytical Laboratories Inc. ("bioLytical"), a global leader in rapid diagnostic tests, proudly announces the immediate availability of its INSTI® HCV Antibody Test in the Australian market. This is the first point-of-care rapid test for hepatitis C antibody detection in the country, with its inclusion in the Australian Register of Therapeutic Goods (ARTG number: 448926).

This milestone comes at a crucial time as Australia risks not achieving the 2030 hepatitis C elimination target despite making progress in diagnosing and connecting people to treatment. Data from 2023 shows substantial declines in testing over recent years, making a renewed focus on preventing new infections and connecting people to treatment vital to ending HCV as a public health threat.

Robert Mackie, bioLytical CEO, says, “This approval is a significant achievement for us. Our INSTI® HCV Antibody Test provides a rapid and reliable tool to identify hepatitis C cases quickly, helping healthcare professionals test high-risk populations and reduce transmission.”

Regular access to rapid testing plays a pivotal role in ending hepatitis C as a public health threat. INSTI®'s innovative platform makes it an ideal first-line assay for hepatitis C antibody detection, delivering highly accurate results in one minute. Regular access to testing is proven to help ensure quick identification of potential hepatitis C infections and facilitate quick connections to care while helping to reduce onward transmission. The INSTI® HCV Antibody Test meets an important clinical need by avoiding venepuncture, decreasing delayed treatment, and improving connections to follow-up for treatment and care.

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 over 99% accuracy in detecting HCV antibodies

In 2022, data shows an estimated 60% of people diagnosed in Australia with hepatitis C from 2016 to 2022 had received treatment. However, approximately 74,400 individuals still live with hepatitis C, highlighting the urgent need for enhanced testing and treatment access to meet the 2030 elimination goal.

Mackie says, “Our entry into the Australian market with the INSTI® HCV Antibody Test is a critical step towards helping reduce the onward transmission of HCV. Rapid, accurate testing is essential in the fight against hepatitis C, and our INSTI® tests are designed to meet this urgent need.” Mackie adds, “Australia faces substantial challenges with hepatitis C, especially among high-risk populations, and our rapid test platform provides a powerful tool to assist in screening cases quickly and accurately. Our goal is to help increase testing for at-risk populations and ultimately reduce transmission, helping achieve the 2030 goal of eliminating the disease as a public health threat.”

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