Co-Diagnostics Grabs CE Mark for Coronavirus IVD

Co-Diagnostics has been part of the coronavirus conversation for the past two months. Whether it’s been educating the public about the disease or developing diagnostics for the virus, the company has been at the forefront. Now the Salt Lake City, UT-based company has received CE mark for the Logix Smart Coronavirus COVID-19 Test, an in vitro diagnostic (IVD).

Co-Diagnostics said it shipped samples of the Research Use Only version of its test to distributors in Italy and Germany last week, which allowed future customers to confirm the quality and sensitivity of the product prior to the IVD being available, and the company to accelerate the sales efforts of its diagnostic.

In a release, Dwight Egan, CEO of Co-Diagnostics, said, “Co-Diagnostics has received overwhelming interest in our novel coronavirus diagnostic from all over the world since first announcing its development a month ago. As the disease has spread from China, so have concerns about the global health community’s ability to contain and control it. The first step in containment is a prompt, accurate diagnosis, and we are pleased to provide this product to those areas that are able to utilize a CE-marked IVD to protect their residents and visitors from a disease that has already affected millions.

The approval in Europe comes at a time when there are 80,370 cases worldwide. About 2,707 have succumbed to the virus, according to World ometer.