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CoSara Diagnostics bags CDSCo clearance for SARAPLEX Influenza Multiplex (IFM) test kit
IMT News Desk
CoSara Diagnostics bags CDSCo clearance for SARAPLEX Influenza Multiplex (IFM) test kit
IMT News Desk
The kit will be used as an in vitro diagnostic (IVD) for the detection and differentiation of Influenza A and Influenza B
Molecular diagnostics company Co-Diagnostics announced that CoSara Diagnostics, its joint venture for manufacturing and sales in India, has received clearance from the Central Drugs Standard Control Organization (CDSCO) in India to manufacture and sell its SARAPLEX Influenza Multiplex (IFM) Test Kit to clinical laboratories as an in vitro diagnostic (IVD) for the detection and differentiation of Influenza A and Influenza B.
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 utilise 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 Dwight Egan, CEO, Co-Diagnostics. "We are pleased that our Co-Primers technology will help to combat respiratory illnesses in India as the world continues to adjust in the wake of the pandemic, and while we work with CoSara in preparation for playing an important role in the next stage of our Company's growth with the upcoming launch of our Co-Dx PCR Pro instrument."
CoSara Director Mohal Sarabhai commented, "This test marks the 15th of CoSara's clinical lab tests to receive IVD clearance by the CDSCO, and adds to our expanding menu of valuable diagnostic tools available to our growing distributor and laboratory customer base. It strengthens our foundation for future growth as CoSara also assists in the progress of point-of-care testing across India, and prepares to provide manufacturing, distribution, and regulatory support for the forthcoming Co-Dx PCR platform."
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