Co-Diagnostics, Inc., a molecular diagnostics company with a unique, patented platform for the development of diagnostic tests, announced that its Logix Smart™ Coronavirus COVID-19 Test has been approved for sale in Mexico by the Mexican Department of Epidemiology (“InDRE”) after InDRE 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 may gain clearance to be sold into the Mexican healthcare market.
Co-Diagnostics also announced that CoSara, the Company’s 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% sensitivity and 100% 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.
About Co-Diagnostics, Inc.:
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.