Co-Diagnostics says India JV receives CDSO clearance for its COVID-19 2-gene multiplex test

Co-Diagnostics Inc (NASDAQ:CODX) reported that its India manufacturing and sales joint venture CoSara Diagnostics Pvt Ltd has received clearance from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell its Saragene COVID-19 2-gene multiplex RT-PCR test as an in-vitro diagnostic for the qualitative detection of the SARS-CoV-2 virus. The CDSCO is India’s equivalent of the US Food and Drug Administration (FDA). Co-Diagnostics CEO Dwight Egan said in statement: "Tests built on our CoPrimer technology have several advantages over other platforms, including the enhanced multiplex capabilities. We believe that the highly specific nature of the new Saragene test, which follows World Health Organization guidance, will help CoSara be able to play an even more active role in the battle against this pandemic." READ: Co-Diagnostics' detection of infectious disease has led it to join the coronavirus fight with flagship test CoSara Director Mohal Sarabhai also weighed in: "Our honorable Prime Minister Shri Narendra Modi has endorsed the hike in number of available RT-PCR tests to keep the COVID-19 positivity rate under 5%. With this clearance in place, CoSara is geared up for this challenge by providing affordable, high quality, 'Made in India' 2-gene multiplex COVID-19 RT-PCR tests across the country." The Saragene test kit uses the patented CoPrimer technology developed by Co-Diagnostics, designed for use with saliva and other respiratory tract samples such as nasal swabs or sputum, and is based on a test originally designed by the company. Both the CoSara and Co-Diagnostics test target two gene markers of the SARS-CoV-2 genome, RdRp and E-gene, to identify the presence of the virus, and were designed to meet the needs of those markets where government or regulatory bodies recommend a multi-target coronavirus diagnostic. Co-Diagnostics also announced recently that its Logix Smart ABC (Influenza A/B, SARS-CoV-2) test and its Logix Smart SARS-CoV-2 multi-gene test were both awarded CE marks from European regulators, which allows the products to be sold as in-vitro diagnostics. The Logix Smart ABC test kit is capable of simultaneous detection of, and differentiation between, Influenza A, Influenza B and SARS-CoV-2, the virus that causes COVID-19.  CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis C and human papillomavirus (HPV) to be manufactured and sold as in-vitro diagnostics in the Indian market. Co-Diagnostics shares climbed more than 16% to $12.28 following Wednesday’s announcement. Contact Sean at sean@proactiveinvestors.com