IDx, a privately-held AI diagnostics company, announced that IDx-DR, an AI-based system for the autonomous detection of diabetic retinopathy, met its endpoints in a pivotal FDA trial involving 900 people with diabetes. IDx-DR was developed to assess for diabetic retinopathy during routine office visits with primary care providers, with results available in minutes. Diabetic retinopathy is a leading cause of blindness in the US, but vision loss is preventable if the disease is detected and treated early.
IDx-DR has been under review by the FDA since January. The submission, which included data from the clinical trial, was granted expedited review under the FDA’s Breakthrough Device program. If cleared by the FDA, IDx-DR is expected to become the first autonomous, AI-based diagnostic system intended for use in the front lines of healthcare.
The trial was conducted at 10 primary care sites across the US to evaluate the diagnostic accuracy of IDx-DR in detecting moderate to severe diabetic retinopathy, including macular edema. The results met the study hypotheses that were developed in consultation with FDA and demonstrated that the IDx-DR system exceeded these performance goals.
“We are very pleased with the diagnostic accuracy and look forward to FDA’s expedited review,” said Michael Abràmoff, MD, PhD, founder and president of IDx. Abràmoff discussed the study results at today’s Macula Society Meeting in Beverly Hills, California. Published results in a peer-reviewed journal are pending.
Findings from the IDx study used real world data collected during the patient care process, rather than data or images procured retrospectively. All tests were performed in a primary care setting by non-clinician staff who received an average of four hours training on the IDx-DR system.
Clinical trial sites have offered favorable feedback. “This technology has great utility and would be solving a real problem,” said John Parker, MD, principal investigator at PMG-Research of Wilmington. “IDx-DR may not only help to identify disease requiring treatment, but the diagnosis also may prompt patients to change their lifestyle and play a more active role in managing their diabetes.”