Salt Lake City, Utah, USA, August 7, 2026
Co-Diagnostics, Inc. has reached a major regulatory milestone by submitting a Dual FDA 510(k) Premarket Notification together with a concurrent CLIA Waiver by Application for its Co-Dx™ PCR Flu A/B & RSV multiplex test designed for use on the Co-Dx PCR Pro® platform. The submission represents a significant step toward bringing real-time PCR molecular diagnostics into decentralized point-of-care healthcare settings, expanding access to highly accurate respiratory testing beyond traditional clinical laboratories. The regulatory package follows completion of extensive clinical and analytical validation studies that evaluated the test’s safety, accuracy, reproducibility, and overall performance. If cleared by the U.S. Food and Drug Administration (FDA) and granted a CLIA waiver, the platform would allow healthcare professionals to perform laboratory-quality PCR testing in physician offices, urgent care centers, community clinics, and other near-patient environments. The milestone highlights Co-Diagnostics’ long-term strategy of combining molecular diagnostic precision with affordable instrumentation and cloud-based digital infrastructure capable of supporting broader infectious disease surveillance and public health monitoring.
FDA Submission Supports Expansion of Point-of-Care PCR Testing
The FDA 510(k) submission includes the Co-Dx™ PCR Flu A/B & RSV assay, a multiplex molecular diagnostic test developed to simultaneously detect Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV) using the company’s Co-Dx PCR Pro® instrument. Alongside the regulatory submission, Co-Diagnostics has filed a CLIA Waiver by Application, which, if approved, would enable use of the platform in waived decentralized healthcare settings without requiring highly specialized laboratory infrastructure. The regulatory application is supported by an extensive clinical validation program involving more than 1,400 symptomatic patients enrolled across nine geographically diverse clinical sites in the United States. In addition, the company completed 27 analytical performance studies comprising more than 10,000 PCR test runs, including multicenter reproducibility studies evaluating performance across multiple operators, healthcare facilities, and testing instruments. These comprehensive data are intended to demonstrate the reliability, consistency, and clinical accuracy required for both FDA clearance and CLIA waiver eligibility.
Cloud-Connected PCR Platform Advances Molecular Diagnostics
The Co-Dx PCR platform combines real-time PCR technology with a lower-cost instrument design and cloud-connected digital infrastructure intended to improve accessibility and scalability of molecular diagnostics. Unlike conventional laboratory-based PCR systems, the platform has been developed to support rapid near-patient testing while maintaining high analytical performance. The integrated cloud infrastructure enables secure aggregation of testing data that may assist healthcare organizations in monitoring localized infectious disease trends and improving situational awareness during seasonal outbreaks. By combining molecular diagnostic quality, simplified operation, and digital connectivity, the platform aims to support broader adoption of PCR testing within decentralized healthcare environments. The company believes these capabilities distinguish the system from existing point-of-care molecular diagnostic platforms while supporting future expansion into additional infectious disease assays and broader diagnostic applications using its proprietary nucleic acid detection technology.
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Regulatory Milestone Supports Future Diagnostic Innovation
The submission marks one of the most significant milestones in Co-Diagnostics’ corporate development as the company advances toward commercialization of its next-generation molecular diagnostic platform. Expansion of point-of-care PCR testing has become increasingly important as healthcare providers seek rapid, accurate diagnostic solutions that improve patient management while reducing dependence on centralized laboratories. If regulatory clearance is obtained, the Co-Dx PCR Pro® platform could strengthen access to molecular diagnostics in outpatient clinics, physician offices, emergency care centers, and other decentralized healthcare settings. Beyond respiratory disease testing, the platform has also been designed to support future development of additional DNA- and RNA-based molecular assays, expanding its potential role in infectious disease diagnostics and precision medicine. As demand continues to grow for rapid molecular diagnostics, FDA clearance and CLIA waiver approval would position Co-Diagnostics to compete in the evolving point-of-care diagnostics market while advancing its mission of making high-quality PCR testing more accessible, affordable, and connected through innovative diagnostic technology.
Source: Co-Diagnostics press release
