Co-Diagnostics Requests FDA Authorization for Coronavirus Diagnostic Device

Co-Diagnostics, a molecular testing firm, has applied for emergency use authorization from the FDA for its PCR coronavirus diagnostic tool. 

Co-Diagnostics has provided a comprehensive package for FDA evaluation, comprising the PCR specialist tool, a coronavirus detection test, and a tailored smartphone app – all designed for self-administration. 

Co-Diagnostics’ new device demonstrated the capability to provide outcomes on the individual’s mobile phone within approximately 30 minutes. 

The entire Co-Diagnostic PCR system is currently undergoing thorough evaluation by regulatory bodies, and the product is not yet accessible for purchase. 

Dwight Egan, head executive of Co-Diagnostics, stated, “In addition to the development of new technologies from the ground-up by a world-class team to decentralise PCR diagnostics technology and make it available at the point-of-care and in at-home settings, it also required the new technology to be able to be commercialised at a price point that is relevant worldwide.” 

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