Original from: PR Newswire
Co-Diagnostics, Inc. (Nasdaq: CODX) ("Co-Dx" or "the Company"), a molecular diagnostics company with a unique, patented platform for the development of molecular diagnostic tests, today announced that it has submitted a Dual 510(k) premarket notification, with a concurrent CLIA Waiver by Application, to the U.S. Food and Drug Administration ("FDA") for the Co-Dx™ PCR Flu A/B & RSV upper respiratory multiplex test on the Co-Dx PCR Pro® instrument*. The submission follows the Company's previously announced completion of the clinical and analytical performance studies supporting the test.
"The submission of this 510(k) premarket notification and CLIA Waiver by Application represents one of the most significant milestones in Co-Diagnostics' history and reflects years of investment in developing the Co-Dx PCR platform," said Dwight Egan, Chief Executive Officer of Co-Diagnostics. "With this submission, we are entering the next phase of our regulatory pathway as we move towards our goal of bringing decentralized PCR diagnostics closer to the patient through a platform designed to improve accessibility, affordability and ease of use, with a cloud-based infrastructure built to power situational awareness as infections spread through communities."
The submission is supported by the clinical and analytical performance studies previously reported by the Company, including a clinical study enrolling more than 1,400 symptomatic patients across nine geographically distinct U.S. clinical sites, and an analytical program spanning 27 studies and over 10,000 upper respiratory PCR test runs. The analytical work included a multicenter reproducibility study, which evaluated performance across multiple operators, sites and instruments. Together, these studies support the Company's concurrent CLIA Waiver by Application, which, if granted, would enable use of the test in decentralized waived point-of-care settings and contribute to expanded access to molecular PCR testing outside traditional laboratory environments.
The Co-Dx PCR platform combines real-time PCR quality with a lower-cost instrument and consumable model, and integrates an innovative cloud-based infrastructure with data aggregation with the goal of helping to track localized outbreaks as they occur. These features differentiate the platform from existing decentralized and point-of-care molecular systems and support the Company's expansion into near-patient and decentralized testing environments.
Source: Co-Diagnostics Submits FDA 510(k) Premarket Notification for Upper Respiratory Point-of-Care Test
