Molecular diagnostics company Co-Diagnostics (Co-Dx) has sought emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for its Co-Dx PCR Covid-19 test with Co-Dx PCR Pro instrument.
Co-Dx’s submission for review by the FDA includes the PCR Pro instrument, Covid-19 detection test and a mobile application, all custom-made for point-of-care and at-home use.
The test kit operates on the real-time polymerase chain reaction (PCR) Co-Primers technology and has demonstrated the capability to detect Covid-19 from anterior nasal swab samples in clinical evaluations.
