Healthcare Business

Why This FDA Update Is Huge for Co-Diagnostics

Chris Lange

Co-Diagnostics Inc. (NASDAQ: CODX) shares popped on Monday after the company announced a key update from the U.S. Food and Drug Administration (FDA). Essentially, Co-Diagnostics obtained Emergency Use Authorization (EUA) for its Logix Smart Coronavirus COVID-19 Test for SARS-CoV-2.

Testing for the coronavirus has become a lucrative field. A couple of other companies specifically dealing with the testing aspect are Quest Diagnostics Inc. (NYSE: DGX) and Becton, Dickinson and Co. (NYSE: BDX). Their stocks have seen solid gains since they entered the coronavirus test business, and Co-Diagnostics is no longer a penny stock.

Co-Diagnostics had initiated sales of its CE-IVD test to the European community and to other global markets that accept a CE marking as valid regulatory approval following routine local product registration.

It also began offering its COVID-19 test to some U.S. Clinical Laboratory Improvement Amendments (CLIA) labs in March 2020, as a result of the FDA’s policy for diagnostic tests for COVID-19 during the current public health emergency.

The test can be used by clinical laboratories certified under CLIA to detect the presence of the virus that causes COVID-19.

Dwight Egan, CEO of Co-Diagnostics, commented:

We believe that this authorization confirms the quality and performance of our COVID-19 test, and that it is a significant step in opening more doors and helping this test to reach an even wider audience. Many experts agree that accessibility of widespread testing is an important element to ‘flattening the curve’ as U.S. cases of COVID-19 continue to rise, and that increased testing throughput is vital to achieve this objective. We look forward to continuing our goal of increasing the availability of advanced, high-throughput, and cost-effective COVID-19 testing solutions both close to home and across the globe.

Co-Diagnostics stock traded up about 25% on Monday to $10.28, in a 52-week range of $0.69 to $21.75. The consensus price target is $19.00.