Co-Diagnostics seeks FDA authorisation for Co-Dx PCR Pro platform
28 Dec 2023
AcquisitionDiagnostic Reagents
The molecular diagnostics company’s EUA submission includes the PCR Pro instrument, PCR Covid-19 detection test, and mobile app, developed based on its patented real-time polymerase chain reaction (PCR) Co-Primers technology
Co-Diagnostics submitted Co-Dx PCR Pro for FDA EUA. (Credit: Mufid Majnun on Unsplash)
US-based Co-Diagnostics has submitted its Co-Dx PCR Covid-19 test with Co-Dx PCR Pro instrument to the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA).
The regulatory submission includes the PCR Pro instrument, PCR Covid-19 detection test kit, and mobile app, for use in point-of-care and at-home settings.
In clinical trials, the Co-Dx Covid-19 test kit for the PCR Pro instrument has been shown to detect the presence of Covid-19 in anterior nasal swab samples.
The PCR test displayed results on the user’s mobile device within 30 minutes.
Co-Diagnostics CEO Dwight Egan said: “This new platform technology is a significant step towards advancing the company’s mission to increase the accessibility of PCR diagnostics.
“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.
“Diagnostics, along with vaccines and therapeutics, are a vital tool in helping to combat illnesses like TB, which remains a significant problem in India and many other countries despite being a highly treatable disease.”
Co-Diagnostics said that the tests on its new Co-Dx PCR at-home and point-of-care platform use its patented real-time polymerase chain reaction (PCR) Co-Primers technology.
Its Co-Dx PCR platform includes the PCR Home and PCR Pro instruments, a mobile app, and all related test kits.
The US-based molecular diagnostics company is developing a menu of future tests for the new platform, including tuberculosis (TB) and human papillomavirus (HPV).
In addition, the company is developing an upper respiratory multiplex panel to detect influenza A/B, Covid-19 and respiratory syncytial virus (RSV) within a single sample.
Last year, Co-Diagnostics completed the acquisition of two US-based biotechnology companies Idaho Molecular and Advanced Conceptions.
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