Co-Diagnostics, a molecular diagnostics company with a patented platform for the development of molecular diagnostic tests, has submitted its Co-Dx PCR COVID-19 test for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA).
The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings, according to Co-Diagnostics.
Tests run on the new platform use the company’s patented real-time polymerase chain reaction (PCR) Co-Primers technology. The Co-Dx COVID-19 test kit for the PCR Pro instrument included in the company’s FDA submission has been shown in clinical evaluations to detect the presence of COVID-19 in anterior nasal swab samples, with results displayed on the user’s smartphone or mobile device in approximately 30 minutes, the company says.
The menu of future tests that are currently in development for the new platform includes tuberculosis (TB) and human papillomavirus (HPV), as well as an upper respiratory multiplex panel that will detect influenza A/B, COVID-19, and respiratory syncytial virus (RSV) within a single sample. All three tests have also been the subject of grant support by notable funding bodies over the last half of this year.
Further reading: Co-Diagnostics Completes Acquisition for At-Home, Point-of-Care Platform
“This new platform technology is a significant step towards advancing the company’s mission to increase accessibility of PCR diagnostics,” says Dwight Egan, CEO of Co-Diagnostics. “In addition to the development of new technologies from the ground-up by a world-class team to decentralize 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 commercialized 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. We are pleased to announce this submission to the FDA for this new platform.”
*The Co-Dx PCR at-home and point-of-care platform (including the PCR Home, PCR Pro, mobile app, and all associated test kits) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
