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News & Trends - MedTech & Diagnostics

Australia set to launch first point-of-care hepatitis C test

Health Industry Hub | May 27, 2024 |

Diagnostics & MedTech News: The launch of Australia’s first point-of-care rapid test for hepatitis C antibody detection aligns with the nation’s ongoing efforts to achieve its 2030 hepatitis C elimination goal. Despite advancements in diagnosis and treatment linkage, Australia continues to face challenges in meeting this target.

BioLytical Laboratories has secured an Australian Register of Therapeutic Goods (ARTG) listing for INSTI HCV antibody test. Designed for ease of use in clinics and emergency settings, the test provides results in just one minute after a simple finger prick procedure, boasting an accuracy rate of over 99% in detecting HCV antibodies.

Robert Mackie, CEO of BioLytical, stated “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.”

Mackie underscored the importance of this launch, commenting, “Our entry into the Australian market with the INSTI HCV test is a critical step towards helping reduce the onward transmission of HCV.”

joint report released by Burnet Institute and the Kirby Institute revealed that hepatitis C treatment rates have declined significantly in recent years. This is despite the introduction of antiviral medications – Gilead’s Epclusa (sofosbuvir/velpatasvir) and AbbVie’s Maviret (glecaprevir/pibrentasvir) – onto the Pharmaceutical Benefits Scheme (PBS).

With 74,400 Australians currently living with hepatitis C, elimination is possible if models of care are better designed to reduce barriers and reach those who are most at risk

“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,” Mackie explained.

“Our aim is to enhance testing among at-risk populations and ultimately reduce transmission, contributing to the 2030 goal of eliminating the disease as a public health threat.”

Production of the diagnostic test is slated to begin at BioLytical’s certified facility in Canada, with distribution planned across Australia.

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