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Co-Diagnostics fulfills clinical evaluation necessary to expand US coronavirus test sales

The company is able to increase domestic sales to labs and others thanks to a recent change in US Food and Drug Administration policy

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Salt Lake City-based Co-Diagnostics is also the first US company to receive a CE-mark from the European Union for its coronavirus diagnostic test

Co-Diagnostics Inc (NASDAQ:CODX) is ramping up sales of its two-hour Logix Smart COVID-19 Test in the US after the company successfully completed a clinical evaluation. 

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.

READ: Co-Diagnostics JV becomes first Indian company licensed to manufacture coronavirus test kits

"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] 

Follow him on Twitter @andrew_kessel

Quick facts: Co-Diagnostics

Price: 18.89 USD

NASDAQ:CODX
Market: NASDAQ
Market Cap: $518.67 m
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Co-Diagnostics to reach wider audience with FDA Emergency Use Authorization...

Co-Diagnostics Inc (NASDAQ:CODX) CEO Dwight Egan tells Proactive the molecular diagnostics company's Logix Smart coronavirus test has obtained Emergency Use Authorization from the FDA to be used to diagnose SARS-CoV-2. Egan says the authorization confirms the quality and performance of the...

on 04/07/2020

3 min read