17 August 2020 | News
Australia joins the United States, India, Mexico, the European Community and others as a region where the Company's test can be sold and used as a coronavirus in vitro diagnostic
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US based Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, has announced that Australia has been added to the list of countries that have authorized the Logix Smart™ COVID-19 for use in detecting SARS-CoV-2, the virus that causes COVID-19.
Australia joins the United States, India, Mexico, the European Community and others as a region where the Company's test can be sold and used as a coronavirus in vitro diagnostic (IVD).
The Australian Government Register of Therapeutic Goods Certificate was recently issued to the Company's distributor in Australia, approving the distributor to supply the Class 3 IVD to the Australian market.
Dwight Egan, CEO of Co-Diagnostics, commented, "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."
The CE-marked and FDA EUA Co-Diagnostics Logix Smart COVID-19 test 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, in the US and many other countries.