Policy change means rapid expansion of Co-Diagnostics' virus test

A new policy announced last week by the U.S. Food & Drug Administration aimed at expediting the availability of COVID-19 diagnostics will allow Salt Lake City-based Co-Diagnostics Inc. to aggressively expand its presence in the U.S. market, the company said in a release.

Co-Diagnostics was the first U.S. company to obtain a CE marking for a COVID-19 test and international shipments have continued to escalate. The CE marking certifies conformity with health, safety and environmental protection standards for products sold within the European Economic Area and other counties of the world.

In the past month, the Co-Diagnostics has shipped its CE-marked Logix Smart COVID-19 test kits to countries all over the world. These include Italy, Germany, the United Kingdom, Turkey, Greece, the Philippines, Thailand, Australia, Paraguay, Ecuador, Israel, South Africa, and Canada, in addition to numerous shipments to customers and research institutions in the United States.

As a result of the change announced last week by the FDA, the Co-Diagnostics test kit will soon be available for use by and marketed to a wide array of U.S. laboratories, without first requiring emergency use authorization.

“The ramifications of this new FDA policy are significant for our company,” said Co-Diagnostics CEO Dwight Egan. “This change will quickly afford Co-Diagnostics even more opportunities to serve the needs of laboratories nationwide, as we play an even larger role in responding to this pandemic. We applaud the FDA’s decision to recognize the dire need for increased access to high-quality COVID-19 tests and to adapt as the situation demands in light of a public health emergency. With no known treatment or approved vaccine for the highly infectious COVID-19, the need for accurate and rapid diagnoses has never been greater.”