The Emmes Corporation announced the completion of a pivotal clinical trial for a new product developed by IDx that could help in detecting diabetic retinopathy, the leading cause of blindness in the United States.
IDx-DR is a fully autonomous artificial intelligence (AI)-based diagnostic system that analyzes images of the retina for signs of diabetic retinopathy, providing instructions for follow-up care based on the level of disease detected. IDx-DR has been granted expedited review by the Food and Drug Administration.
Under contract to IDx, Emmes was responsible for overall clinical operations, site selection and data management. The clinical trial, which was conducted at 10 sites across the US, evaluated 900 patients for the accuracy of IDx-DR to detect moderate to severe diabetic retinopathy, as well as macular edema. IDx, an Iowa City-based company, was founded by world renowned retina specialists and is a leader in automated medical image analysis.
“IDx and Emmes make a stellar team,” said Dr. Anne Lindblad, president and chief executive officer of Emmes. “Our decades of ophthalmology-related research, combined with IDx’ innovative products and artificial intelligence expertise, paved the way for a pivotal clinical trial with great potential.”
According to Dr. Michael Abramoff, founder and president of IDx, “When you have ground-breaking technology that will change the way medicine is practiced, it’s always a challenge to develop a study that will adequately assess whether it is safe for patient care. Emmes has been a great partner along the way in helping us accomplish this.”
Abramoff is optimistic about the trial results, which demonstrated that the IDx-DR system exceeded performance goals. If cleared by the FDA, IDx-DR is expected to become the first autonomous, AI-based diagnostic system to be used in the front lines of health care.
Dr. Nilay Shah, medical officer and project director for Emmes, said this was the first AI-related study for the company. “We believe artificial intelligence offers great promise for the early detection of many diseases, and we hope our work with IDx will pave the way for more AI-based research and treatment opportunities.”
The FDA is expected to make a determination on the IDx-DR system in the coming months.