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Co-Diagnostics Submits At-Home PCR System, COVID-19 Test to FDA

NEW YORK – Co-Diagnostics announced Friday that it has submitted a PCR instrument and COVID-19 test to the US Food and Drug Administration for 510(k) clearance. The firm has submitted the system for over-the-counter use and will subsequently pursue point-of-care clearance.

The Co-Dx PCR Pro instrument uses real-time PCR, a smartphone interface, and test cups with Co-Dx co-primer technology, the Salt Lake City-based company said in a statement.

Co-Dx is also developing diagnostics for tuberculosis, human papillomavirus, and group A strep for the system, as well as a multiplex test for respiratory diseases including influenza A and B, COVID-19, and respiratory syncytial virus. These tests are in varying stages of development and preparation for clinical evaluations, the firm said.

"This FDA application is an important milestone in our company's growth and represents a crucial step towards closing the gap that separates many patients and communities around the world from gold-standard diagnostics," Co-Dx CEO Dwight Egan said in a statement.

Last year, Co-Dx was awarded $1.2 million from the National Institutes of Health's Rapid Acceleration of Diagnostics (RADx) Tech program to support development of the respiratory panel, and $2.3 million from the Bill and Melinda Gates Foundation to develop its TB and HPV assays for the system. The Gates Foundation subsequently awarded the firm $9 million over 24 months to support the TB assay development.