Co-Diagnostics JV CoSara cleared by Indian FDA for SARS-CoV-2 multiplex tests

 

• Co-Diagnostics (CODX +15.5%) announces that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance by the Central Drugs Standard Control Organization in India to manufacture and sell its Saragene, Logix Smart SARS-CoV-2 (genes RdRp/E) multiplex tests have obtained regulatory authorization to be sold as in vitro diagnostics (IVD) for COVID-19 detection.
• The Saragene tests use the Company's patented CoPrimer technology and are designed for use with saliva and other respiratory tract samples, such as nasal swabs or sputum.
• Recently, the company announced receipt of a CE marking for its Logix Smart™ SARS-CoV-2 (genes RdRp/E) multiplex test.
• 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 IVDs in the Indian market.
• https://seekingalpha.com/news/3639504-co-diagnostics-soars-15-after-jv-cosara-receives-clearance-from-indian-fda-for-sars-covminus