Australian company Microbio has announced that its COVID-19 tests have been approved for sale and use in Europe.
The company has been granted a CE Mark following extensive testing of its product across three continents.
Microbio, which is based at Queensland’s Translational Research Institute, says the approval will enable the privately held scale-up to move into additional international markets.
The approval follows comprehensive testing in Australia, the US, Italy and India, and comes at a time when the company is seeking to establish advanced manufacturing to produce its patented reagents.
Microbio chief scientific officer Dr Flavia Huygens said the company pivoted in the early period of the pandemic to adapt its core technology to develop two distinct versions of InfectID-COVID-19 tests – Detection and Replicating tests.
Microbio said its InfectID-COVID-19 tests have been designed to specifically target unchanging regions of the SARS-CoV-2 genome and are unlikely to have their accuracy reduced as new variants of SARS-CoV-2 emerge.
"This successful detection of all variants includes the Mu variant," said the company. "The InfectID-COVID-19 tests have been compared to other real-time Polymerase Chain Reaction (PCR) tests that claim to detect all variants, and it had a 100% success rate."
“We know that this is one of the biggest limitations of the current PCR-based tests – they can’t tell if the virus they’re picking up is replicating and infectious, or simply inactive pieces of the virus that the body sheds as it fights the virus,” said Dr Huygens.
“The good thing about our tests, is that they use standard laboratory real-time PCR equipment. There’s no need for labs to buy expensive new equipment or retrain their staff. The reagent has been tested in a National Association of Testing Authorities, Australia (NATA) accredited lab on existing equipment.”
Microbio CEO Paul Carboon said the company has the immediate capacity to deliver 500,000 tests a week from a manufacturing facility in Canada. He added that the company expects to manufacture in Australia and is seeking government support to make its technology available to the health system in Australia and key export markets.
“This is a breakthrough. As the world looks to open safely, having testing that detects the presence of SARS-CoV-2 in the early stages of the infection, when the virus is actively replicating (and is likely most infectious) is vitally important and it is exciting that an Australian company has been able to develop this technology.
“We have had considerable interest from overseas including the United States and India, and gaining the CE Mark opens up the world to us,” said Mr Carboon.