The submission includes a CLIA waiver application for point-of-care use of the flu and RSV test on the PCR Pro instrument.
Co-Diagnostics has submitted a Dual 510(k) premarket notification and a concurrent Clinical Laboratory Improvement Amendments (CLIA) Waiver by Application to the Food and Drug Administration (FDA) for its upper respiratory multiplex test.
The submission covers the Co-Dx PCR Flu A/B & Respiratory Syncytial Virus test for use on the Co-Dx PCR Pro instrument, according to a company press release. The filing follows the completion of clinical and analytical performance studies.
The company says the CLIA waiver, if granted, would enable the test to be used in decentralized point-of-care settings. This could expand access to molecular polymerase chain reaction (PCR) testing beyond traditional laboratory environments.
“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,” says Dwight Egan, CEO of Co-Diagnostics, in a release. “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 includes data from a clinical study of more than 1,400 symptomatic patients across nine US clinical sites. Additionally, an analytical program included 27 studies and more than 10,000 test runs, including a multicenter reproducibility study to evaluate performance across various operators, sites, and instruments, the company says.
The platform uses real-time PCR technology and includes cloud-based infrastructure for data aggregation to help track localized outbreaks, according to the company. The platform and its associated tests are currently under review by the FDA and are not yet available for sale.
