bioLytical Laboratories Inc. Announces Launch of its INSTI® HCV Antibody Test for Professional Use in Australia
2024年5月20日 - 7:00AM
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.
About bioLytical Laboratories Inc.:bioLytical Laboratories Inc.
is a privately owned Canadian company focused on researching,
developing, and commercializing rapid medical diagnostics using its
proprietary INSTI® technology platform and its lateral flow line,
iStatis. By delivering accurate results in real-time, INSTI® and
iStatis generate meaningful outcomes for medical professionals,
patients, and public health organizations worldwide and we are key
partners in tackling some of the world's most severe healthcare
challenges. Please visit www.biolytical.com, www.insti.com, and
www.istatis.com for more information.
Sources:
Burnet Institute and UNSW Kirby Institute: Australia’s progress
towards hepatitis C elimination: annual report 2023
Media Contact:
Stephanie Ritchie, Communications Specialist, bioLytical
press@biolytical.com
+1-778-238-9340