Co-Diagnostics gets nod from government agencies in Mexico and India for coronavirus (COVID-19) test kits

Co-Diagnostics Inc (Nasdaq:CODX), a molecular diagnostics company, announced Monday that its coronavirus (COVID-19) diagnostic test has been approved for sale by government agencies in Mexico and India.    In a statement, the Salt Lake, Utah-based company said the Mexican Department of Epidemiology (InDRE) has approved its Logix Smart COVID-19 test after it successfully concluded an evaluation of the test's sensitivity and specificity and its non-reactivity with other respiratory viruses. InDRE, which is akin to the US 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 in the Mexican healthcare market. READ: Co-Diagnostics says coronavirus test shows spotless sensitivity data in independent evaluations Meanwhile, 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 in India, the company added. Co-Diagnostics said CoSara previously received a license from India’s pharma regulatory authority, the Central Drugs Standards Control Organisation (CDSCO), to manufacture the Saragene COVID-19 test kits. The test approved by the CDSCO is the same as the one originally designed by Co-Diagnostics, and will be manufactured in CoSara's GMP-facility in Ranoli, India which is capable of large-scale production. Co-Diagnostics CEO Dwight Egan noted that orders for the company’s 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,” Egan added in a statement. He also said that the company’s technology is “being deployed in many areas in the United States,” providing “high-throughput diagnostic solutions” to improve the quality of COVID-19 detection. “The company has participated in governmental and private initiatives designed to increase test availability," Egan added. The company's Logix Smart COVID-19 test is currently available to all clinical labs 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. Co-Diagnostics has received orders and enquires from more than 50 countries since receiving an Emergency Use Authorization from the Food and Drug Administration (FDA) on April 3. Contact the author Uttara Choudhury at uttara@proactiveinvestors.com Follow her on Twitter: @UttaraProactive