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bioLytical Laboratories Inc. Announces Launch of its INSTI® HCV Antibody Test for Professional Use in Australia

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bioLytical Laboratories Inc. Announces Launch of its INSTI® HCV Antibody Test for Professional Use in Australia

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Nusantaranews, 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

RICHMOND, British Columbia, May 19, 2024 (GLOBE NEWSWIRE) — 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

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