Co-Diagnostics Files for FDA Approval of Point-of-Care Respiratory Test

The submission centers on the Co-Dx PCR Pro instrument, a device designed to bring lab-grade molecular testing directly to patients. According to CEO Dwight Egan, the move represents a multi-year effort to balance diagnostic accuracy with the ease of use required for point-of-care settings. If approved, the test would allow healthcare providers to conduct rapid, high-quality PCR analysis outside of traditional, centralized laboratory facilities.

To support the application, the company compiled data from extensive performance trials. The clinical evidence includes a study of over 1,400 symptomatic patients across nine U.S. sites, complemented by an analytical program involving more than 10,000 test runs. This research focused heavily on reproducibility across different operators and instruments, a critical requirement for securing a CLIA waiver. While the platform remains under regulatory review and is not yet available for commercial sale, the company intends to pair the hardware with a cloud-based infrastructure capable of aggregating data to assist in tracking community-level infection outbreaks.