The company is able to increase domestic sales to labs and others thanks to a recent change in US Food and Drug Administration (FDA) policy allowing companies to begin sales of coronavirus tests while awaiting FDA clearance under Emergency Use Authorization (EUA).
Co-Diagnostics’s own EUA application is currently being reviewed by the FDA.
"Our Logix Smart COVID-19 test has already been deployed on a global basis to five continents as well as to US [Clinical Laboratory Improvement Amendments (CLIA) certified] labs that meet certain requirements, and we are prepared to provide an even greater number of U.S. laboratories and patients access to our test as a result of the new FDA policy,” Co-Diagnostics’ CEO Dwight Egan said in a statement.
On Thursday, Co-Diagnostics’ joint venture in India received a license to manufacture coronavirus tests in the country, which Egan said more than triples the company’s total capacity.
“The demand for reliable, high-quality COVID-19 diagnostics has never been greater, and it continues to grow daily as this disease affects not just patients afflicted with it and their families, but the entire nation as a whole,” Egan said.
"We believe the excellent performance of our COVID-19 test combined with affordable pricing will place it in the vanguard of available testing alternatives worldwide.”
PreCheck orders tests
In a separate statement, PreCheck Health Services Inc (OTCMKTS:HLTY) said it has ordered and paid for 37,500 of Co-Diagnostics' COVID-19 tests and has received the first 7,500 test kits to start filling orders for the product.
Both companies have struck several agreements that give PreCheck the distribution rights to Co-Diagnostics' COVID-19 test and other tests in Romania, Moldova, Ecuador and Panama. PreCheck’s five combined distribution territories have an aggregate population of 188 million.
PreCheck said it believes Co-Diagnostics’ test "is the most accurate test" to detect the presence of the COVID19 infection.
Salt Lake City-based Co-Diagnostics is also the first US company to receive a CE-mark from the European Union (EU) for its coronavirus diagnostic test. It is currently shipping orders for its test kits to 10 to 13 countries across five continents, including America, Europe, Asia and Australia.
Contact Andrew Kessel at [email protected]
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