Canada-based rapid diagnostic tests provider bioLytical Laboratories has announced the commercial launch of its INSTI HCV Antibody Test in the Australian market.
With inclusion in the Australian Register of Therapeutic Goods (ARTG), INSTI HCV has become the country’s first point-of-care rapid test for hepatitis C antibody detection.
The antibody test is designed to be portable and stable, for use in clinics and emergency settings, and provide results within one minute, facilitating rapid triage and access to treatment.
It requires a simple finger prick procedure that requires minimal training and provides more than 99% accuracy in detecting HCV antibodies.
bioLytical is planning to manufacture the new test at its MDSAP/ISO 13485-certified facility in Canada, for sale and distribution across Australia.
bioLytical CEO Robert Mackie said: “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.”
“Our entry into the Australian market with the INSTI HCV Antibody Test is a critical step towards helping reduce the onward transmission of HCV.”
The launch of INSTI test comes at a time when Australia risks not achieving the 2030 hepatitis C elimination target despite progress in diagnosing and connecting people to treatment.
According to the company, regular access to rapid testing would play a key role in preventing hepatitis C as a public health threat.
Its advanced INSTI platform makes it an ideal first-line assay for hepatitis C antibody detection, delivering highly accurate results in one minute.
Also, regular access to testing helped quick identification of potential hepatitis C infections and facilitated quick connections to care while reducing onward transmission.
The INSTI HCV antibody test meets an important clinical need by preventing venipuncture, decreasing delayed treatment, and improving treatment and care, said the company.
Mackie added: “Rapid, accurate testing is essential in the fight against hepatitis C, and our INSTI tests are designed to meet this urgent need.
“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.”
