Australian Trefoil Health Technologies Pty Ltd Marks Major Milestone: TGA Approval for COVID-19 Diagnostic Test Kits in Pandemic Response
Sydney, Australia – May 22, 2020
In a testament to our rapid innovation and dedication to global health challenges, Australian Trefoil Health Technologies Pty Ltd has achieved a key regulatory milestone during the 2020 COVID-19 crisis.
On May 19, 2020, the Therapeutic Goods Administration (TGA) officially included our SARS-CoV-2 IgM/IgG Antibody Test Kit and COVID-19 (SARS-CoV-2) Nucleic Acid Test Kit (PCR-based) in the Australian Register of Therapeutic Goods (ARTG Entry: 336633, Submission ID: DV-2020-IVA-06156-1 / DA-2020-02388-1).
This positioned Trefoil among the earliest Australian companies to secure TGA emergency authorization for both antibody rapid detection and PCR nucleic acid testing solutions, enabling critical support for diagnosis, surveillance, and public health efforts amid the emerging pandemic.
Under the leadership of founders Dr. Drew (former CSIRO scientist) and Dr. Jianguo Yang (pioneer in selenoprotein P research), our team swiftly collaborated with international partners, including Wuhan EasyDiagnosis Biomedicine Co Ltd for the nucleic acid kit, and submitted comprehensive data—including ISO 13485 certification and performance evidence—between March and April 2020.
The TGA inclusion recognized the urgent need for reliable diagnostics, with our PCR kit providing precise viral RNA detection and the antibody kit aiding immune response assessment. Post-market conditions were applied to both products (e.g., 12-month updates on performance, stability, adverse events, and supply restrictions for the antibody kit to qualified healthcare entities) to ensure ongoing safety and compliance.
This achievement embodies our slogan: "Technology is productivity, innovation is competitiveness." It highlights our ability to mobilize high-standard labs and expertise to deliver timely solutions when humanity needed them most.
We thank the entire Trefoil team, partners, and TGA for their collaboration. Together, we continue advancing health through science-driven solutions.
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