INSTI® HCV Antibody Test Launched for Professional Use in Australia by bioLytical Laboratories

Monday, May 20, 2024

bioLytical Laboratories, proudly announces the launch of its INSTI® HCV Antibody Test in the Australian market, marking the first point-of-care rapid test for hepatitis C antibody detection in the country.

This significant milestone, recognized by its inclusion in the Australian Register of Therapeutic Goods (ARTG number: 448926), arrives amidst concerns that Australia may fall short of its 2030 hepatitis C elimination target due to declining testing rates in recent years.

CEO of bioLytical, expresses the significance of this achievement, stating, “This approval marks a major milestone for us. Our INSTI® HCV Antibody Test offers a rapid and dependable solution to swiftly identify hepatitis C cases, enabling healthcare professionals to test high-risk populations and mitigate transmission risks.”

The availability of rapid testing is crucial in the effort to eliminate hepatitis C as a public health threat. With its innovative platform, INSTI® emerges as an ideal first-line assay for hepatitis C antibody detection, delivering highly accurate results in under a minute.

Regular access to testing aids in the prompt identification of potential infections and facilitates swift connections to care, thereby reducing onward transmission. Moreover, the INSTI® HCV Antibody Test addresses a critical clinical need by obviating the need for venepuncture, minimizing delays in treatment, and enhancing connections to follow-up care.

Key features of the INSTI® HCV Antibody Test include:

  • Rapid Results: Delivers outcomes in one minute or less, streamlining triage and treatment access.
  • User-Friendly: Simple finger prick procedure requiring minimal training.
  • Portability and Stability: Suitable for diverse environments, including clinics and emergency settings.
  • High-Quality Manufacturing: Complies with rigorous standards, boasting over 99% accuracy in detecting HCV antibodies.

Despite significant progress in diagnosing and treating hepatitis C in Australia, with an estimated 60% of diagnosed individuals having received treatment from 2016 to 2022, approximately 74,400 individuals still live with the disease. This underscores the urgent need for expanded testing and treatment access to achieve the 2030 elimination goal.

Mackie emphasizes, “Our entry into the Australian market with the INSTI® HCV Antibody Test marks a critical stride towards curbing onward transmission of HCV. Rapid, accurate testing is indispensable in the fight against hepatitis C, and our INSTI® tests are engineered to address this pressing need.

”Australia grapples with significant challenges related to hepatitis C, particularly among high-risk populations, and our rapid test platform provides a potent tool for swiftly and accurately screening cases.

Aim is to bolster testing among at-risk populations and ultimately diminish transmission, contributing to the 2030 goal of eradicating the disease as a public health threat.”

bioLytical will manufacture the INSTI® HCV Antibody Test in its MDSAP/ISO 13485-certified facility in Canada for distribution across Australia. As a global leader in ultra-rapid infectious disease diagnostics, bioLytical is committed to ensuring widespread availability of its test kits throughout the country, empowering all Australians to know their status.






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