Co-Diagnostics, Inc. JV CoSara Receives Clearance from Indian Regulators for Influenza Multiplex PCR Test
The clinical laboratory real-time PCR multiplex test was designed using Co-Dx Co-Primers™ and licensed by the CDSCO for use in diagnostic procedures
CoSara's new real-time multiplex PCR test is built on the Company's patented Co-Primers™ technology and designed to simultaneously detect influenza A (H1N1, H3N2, H7N9, H1N2, H5N1, H2N2, H9N2, H10N8, H5N6, H7N7, H7N4, H7N2 and H2N1), influenza B (Yamagata and Victoria strains) and to differentiate between H1N1 and H3N2. Co-Primers utilize a unique design architecture to combat common issues with real-time PCR that can lead to inaccurate results, specifically primer dimer propagation, and which are magnified in multiplex reactions.
"The importance of accurate, reliable PCR testing at the high-throughput clinical laboratory level remains critical," remarked
CoSara Director
CoSara has previously received CDSCO clearance for RT-PCR tests for Mycobacterium tuberculosis, malaria, hepatitis B, hepatitis B viral load, hepatitis C, hepatitis C viral load, HPV types 16 and 18 and HPV-HR, two COVID-19 assays, chikungunya, dengue, a dengue/chikungunya duplex test, and a Flu A/Flu B/COVID-19 ("
*The Co-Dx PCR platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.
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