SALT LAKE CITY, Utah, July 1, 2026
Co-Diagnostics, Inc. has reached a significant regulatory milestone by completing the clinical and analytical validation studies supporting its planned FDA 510(k) submission for the Co-Dx™ PCR Flu A/B & RSV multiplex point-of-care diagnostic test running on the Co-Dx PCR Pro® platform. The achievement positions the company to submit a Dual 510(k) application together with a CLIA Waiver by Application during the third quarter of 2026, potentially expanding access to highly accurate molecular testing in decentralized healthcare settings. The completed validation program included more than 1,400 symptomatic patients enrolled across nine geographically diverse U.S. clinical sites, alongside 27 comprehensive analytical performance studies involving over 10,000 PCR test cup runs. These extensive studies were designed to demonstrate the test’s reliability, reproducibility, and clinical performance under both laboratory and real-world point-of-care conditions. The milestone highlights Co-Diagnostics’ commitment to advancing rapid molecular diagnostics capable of delivering laboratory-quality PCR testing closer to patients while supporting faster diagnosis of common respiratory infections including Influenza A, Influenza B, and Respiratory Syncytial Virus (RSV).
Clinical Validation Supports FDA 510(k) and CLIA Waiver Submission
The completion of clinical and analytical validation studies marks one of the final requirements before Co-Diagnostics submits its regulatory package to the U.S. Food and Drug Administration (FDA). The comprehensive clinical study enrolled more than 1,400 symptomatic patients across nine clinical research sites located throughout the United States, ensuring robust evaluation of the assay across diverse patient populations and healthcare environments. In parallel, the company completed 27 analytical performance studies, generating over 10,000 individual PCR test cup runs to verify analytical sensitivity, specificity, precision, reproducibility, and overall system performance.
These datasets are expected to form the foundation of the company’s planned Dual 510(k) submission while simultaneously supporting its application for a CLIA Waiver, which would allow the platform to be used in decentralized healthcare environments such as physician offices, urgent care centers, retail clinics, and other near-patient settings without requiring highly specialized laboratory personnel.
Point-of-Care PCR Platform Designed for Decentralized Testing
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A major component of the validation program focused on demonstrating the reproducibility of the Co-Dx PCR Pro® platform when operated by untrained healthcare personnel across multiple testing locations. External multicenter reproducibility studies confirmed consistent assay performance across different operators, instruments, and clinical environments, an essential requirement for obtaining a CLIA Waiver by Application. The Co-Dx™ PCR Flu A/B & RSV multiplex test utilizes the company’s proprietary molecular diagnostics platform to simultaneously detect multiple upper respiratory pathogens using highly sensitive polymerase chain reaction (PCR) technology.
Unlike many conventional laboratory PCR systems, the platform has been specifically designed for point-of-care and near-patient testing, enabling healthcare providers to deliver rapid, accurate molecular diagnostic results while improving clinical decision-making and patient management during respiratory illness outbreaks.
Regulatory Progress Strengthens Molecular Diagnostics Pipeline
Completion of these extensive validation studies represents an important advancement in Co-Diagnostics’ broader strategy to expand access to next-generation molecular diagnostics across decentralized healthcare settings. The company continues developing its patented Co-Dx PCR platform, which supports both point-of-care and future at-home diagnostic testing applications across infectious diseases and additional molecular testing markets. Successful FDA clearance would position the company to commercialize its innovative PCR platform in a growing global diagnostics market where demand continues increasing for rapid, highly accurate molecular testing outside traditional laboratory environments.
By combining laboratory-quality PCR performance with simplified operation and decentralized accessibility, Co-Diagnostics aims to improve patient care through faster diagnosis and treatment decisions while supporting broader adoption of precision molecular diagnostics across hospitals, physician offices, community clinics, and other healthcare facilities. The planned Q3 2026 FDA submission represents a critical milestone toward achieving these commercialization objectives.
Source: Co-Diagnostics press release
