The company’s distributor in the country has received a Register of Therapeutic Goods certificate from the Australian government. The country joins the US, India, Mexico, European Community countries and others in allowing the sale and use of the in vitro diagnostic test.
The move comes on the heels of a coronavirus outbreak in Melbourne, the company said, which prompted the state of Victoria to declare a state of disaster.
"Co-Diagnostics recognizes the importance of accurate, high-throughput testing in combating surges of coronavirus infections, and we are gratified that our test is being used to help people in so many countries to safely navigate this ongoing pandemic, now also including Australia,” CEO Dwight Egan said in a statement.
Co-Diagnostics’ Logix Smart test has earned emergency use authorization from the US Food and Drug Administration and a CE Mark from European regulators. It is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA) and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19.
The company’s Logix Smart COVID-19 test’s high accuracy has been independently validated by PathWest Laboratories in Australia, the Indian National Institute of Pathology, and the Mexican Department of Epidemiology.
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