Co-Diagnostics, Inc.

Co-Diagnostics, Inc. develops, manufactures, and sells reagents for diagnostic tests that detect and analyze nucleic acid molecules (DNA or RNA), including molecular tools for infectious diseases. The company's diagnostic systems aim to provide dependable, low-cost molecular testing by simplifying complex procedures in test development and administration. Co-Diagnostics' technology uses a proprietary approach to polymerase chain reaction (PCR) test design, called Co-Primers®, which reduces primer-dimer amplification (false positives) that can interfere with identifying target DNA/RNA. Using this system and reagents, the company has designed and obtained regulatory approval to sell PCR diagnostic tests for COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus, malaria, chikungunya, dengue, and the Zika virus. These initial diagnostic tests are cleared for use only in clinical labs. Co-Diagnostics has also developed a portable diagnostic device and test system for point-of-care and at-home use, referred to as the "Co-Dx™ PCR platform." This system includes the Co-Dx™ PCR Pro® instrument, a patent-pending diagnostic test cup system, and a mobile application. The Co-Dx PCR platform is designed to offer affordable, reliable PCR testing in point-of-care and at-home settings. This platform is currently subject to U.S. Food and Drug Administration (FDA) review and is not available for sale at the time of this filing. In June 2024, the company completed its first FDA 510(k) clearance application for the Co-Dx PCR Pro instrument, the Co-Dx PCR COVID-19 Test, and the Co-Dx PCR mobile app for over-the-counter (OTC) use.