West Perth company Avicena Systems has ticked off another big achievement, with the Therapeutic Goods Administration authorising its locally developed diagnostic technology.
The TGA has authorised the listing of the Avicena Sentinel on the Australian Register of Therapeutic Goods (ARTG) as a Class 1 In Vitro Diagnostic (IVD) device.
The Sentinel is a fully-automated laboratory instrument for running diagnostic assays.
It processes saliva or nasal samples to identify respiratory pathogens such as COVID or influenza on a vast scale.
Executive chairman and chief scientific officer Paul Watt said the ARTG listing represented a significant milestone.
"The TGA is regarded as one of the most rigorous regulatory agencies in the world, so this is a big step forward for the Sentinel and Avicena," he said.
"The Sentinel is one of only two Australian-developed molecular diagnostics analysers currently listed on the ARTG.”
Dr Watt said it was a testament to the innovation and efficiency of Avicena's team in developing and validating the Sentinel instrument in less than two years.
Chief executive Tony Fitzgerald said the ARTG listing would provide more confidence to potential customers and facilitate Avicena's ability to market the Sentinel instrument overseas.
"A TGA listing is highly respected by international customers and will prove invaluable in discussions with current and prospective partners and foreign medical regulatory bodies, as we continue to take this WA innovation to global markets," Mr Fitzgerald said.
Avicena said it was also achieving positive outcomes from ongoing trials in the aged care and resources sectors, which supported Sentinel's potential as an effective biosecurity solution to manage outbreaks and prepare against future pandemic threats.
The Sentinel is able to process up to 100,000 samples daily, with results available within 30 minutes.
Its benefits include being cheaper and easier to scale than PCR testing with reported accuracy exceeding 94 per cent.
