Big news is out on Co-Diagnostics Inc (NASDAQ:CODX). The FDA will now allow the Company to aggressively expand its presence in the U.S. market for its COVID-19 test. This is a huge development and why we believe NASDAQ:CODX will soon be trading over its recent highs above $21. Taking a further look at this coronavirus stock, there’s a lot to like with NASDAQ:CODX.
Co-Diagnostics, Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets a new, state-of-the-art diagnostics technology. The Company’s technology is utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules (DNA or RNA). The Company also uses its proprietary technology to design specific tests to locate genetic markers for use in industries other than infectious disease and license the use of those tests to specific customers.
One of the biggest crises facing the Trump administration is a lack of adequate testing for COVID-19. This is where NASDAQ:CODX steps in. 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. In the past month, the Company has shipped its CE marked and research use 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.
Previous domestic shipments to date have been in accordance with the FDA’s policy change on February 29, 2020 that allows U.S. CLIA laboratories to use the Company’s COVID-19, under certain conditions. Now, as a result of the change announced last night by the FDA, the Company’s 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. Co-Diagnostics CEO Dwight Egan said:
“The ramifications of this new FDA policy are significant for our Company. 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. Our cost-effective Logix Smart CODIV-19 test has been designed to run on a variety of commercially available platforms, with easy-to-interpret results in under two hours. We are confident in our ability to meet the growing demand for this diagnostic.”
The news from the FDA is a game changer for NASDAQ:CODX. The need for testing is urgent and over 300 million Americans need to be tested. Do the math and there’s a lot to like with CODX stock. Good luck!
We will be updating our subscribers as soon as we know more. For the latest updates on NASDAQ:CODX, sign up below!
Disclosure: We have no position in NASDAQ:CODX and have not been compensated for this article. We may or may not initiate a LONG postion in NASDAQ:CODX after 72 hours of publication.