Co-Diagnostics’ COVID-19 Test Kits Cleared for Sale in Mexico and India

Co-Diagnostics Inc., a molecular diagnostics company with a patented platform for developing diagnostic tests, announced that its Logix Smart Coronavirus COVID-19 test was approved for sale in Mexico by the Mexican Department of Epidemiology (InDRE) after the agency successfully concluded an evaluation of the test’s sensitivity and specificity and its non-reactivity with other respiratory viruses. InDRE, which is analogous to the U.S. Centers for Disease Control and Prevention (CDC), is required to evaluate any test to detect the disease before the test can be cleared to be sold in the Mexican healthcare market.

Co-Diagnostics also announced this week that CoSara, its joint venture for manufacturing in India, expects to now begin filling orders following the successful evaluation of CoSara’s Saragene COVID-19 RT-PCR test kit by the Indian Council of Medical Research (ICMR). The evaluation showed 100 percent sensitivity and 100 percent specificity without any cross reactivity with other respiratory viruses and it has been cleared for sale to the Indian market. 

CoSara has received a license from the Central Drugs Standards Control Organisation (CDSCO) to manufacture the Saragene COVID-19 test kits. The test approved by the CDSCO was the same as that originally designed by Co-Diagnostics, and will be manufactured in CoSara’s GMP manufacturing facility in Ranoli, India which is capable of large scale production.
 
Dwight Egan, Co-Diagnostics CEO, remarked “Orders for our Logix Smart COVID-19 test continue to be strong. We believe our continued growth is due to our ability to meet testing needs on a timely basis, with a high quality, cost-efficient, easy to process test. We are pleased that our technology is also being deployed in many areas in the United States, providing high-throughput diagnostic solutions to improve the quality of COVID-19 detection in those communities. The Company has participated in governmental and private initiatives designed to increase test availability.”

The Company’s Logix Smart COVID-19 test is currently available to all clinical laboratories certified under Clinical Laboratory Improvement Amendments (CLIA), and is authorized to be used for the diagnosis of SARS-CoV-2, the virus that causes COVID-19.
 
The expansion of Co-Diagnostics’ sales regions for its COVID-19 test kits comes just two months after the company announced the closing of a registered direct offering of 470,000 shares of its common stock, at a purchase price of $9 per share, in a registered direct offering priced at-the-market under the Nasdaq rules, for gross proceeds of approximately $4.2 million.
 
H.C. Wainwright & Co. acted as the exclusive lead placement agent for the offering. Maxim Group LLC acted as co-placement agent.
 
Co-Diagnostics intends to use the net proceeds from this offering for acquisition of PCR (polymerase chain reaction) equipment and raw materials to be used in connection with sale of tests used to diagnose infectious disease, including strains and mutations of coronavirus, as well as research and development costs associated with test development for additional pathogens and test menu expansion, and for working capital and other general corporate purposes.
 
The shares of common stock were offered by Co-Diagnostics pursuant to a “shelf” registration statement on Form S-3 that was originally filed on Aug. 14, 2018, and declared effective by the U.S. Securities and Exchange Commission (SEC) on Sept. 7, 2018, and the base prospectus contained therein (File No. 333-226835). The offering of the shares of common stock was made only by means of a prospectus supplement that forms a part of the registration statement.
 
A final prospectus supplement and accompanying base prospectus relating to the shares of common stock being offered has been filed with the SEC.