Co-Diagnostics said Wednesday that it has commenced clinical evaluations for its at-home and point-of-care Co-Dx PCR Home platform and an initial COVID-19 test.
The firm said the evaluations include both clinical and analytical studies to support submissions for regulatory authorizations to the U.S. Food and Drug Administration (FDA) and other regulatory bodies.
Co-Diagnostics added that it is developing a real-time polymerase chain reaction (PCR) platform for the detection of infectious diseases in at-home and point-of-care settings. In the future, pending regulatory authorization for its platform, the company anticipates developing multiplex panels for infectious disease testing.
The firm did not provide a timeline for completing the studies, and noted that the clinical evaluations are dependent on identifying and enrolling symptomatic and asymptomatic COVID-19 positive and negative patients at testing sites.
The start of clinical evaluations follows more than two years of research and development, Dwight Egan, CEO of Co-Diagnostics, said in a statement. “The new at-home and point-of-care testing platform represents a high degree of innovation that brings together the power of our patented co-primer technology [and other proprietary intellectual property],” he said.
