Despite being treatable if diagnosed early, diabetic retinopathy remains a leading cause of blindness among those with the chronic metabolic disease in the US. To support early diagnosis, diagnostics company IDx has developed an AI-based system for rapid detection of diabetic retinopathy.
The IDx-DR tool is designed to be used in primary care facilities where physicians can get diagnostic results in just minutes. In a recent 900-patient clinical trial, IDx found their AI diagnostic was able to accurately detect diabetic retinopathy in diabetic participants.
“We are very pleased with the diagnostic accuracy and look forward to FDA’s expedited review,” said Dr. Michael Abràmoff, founder and president of IDx. The results of their clinical trial were presented at the recent Macula Society Meeting in Beverly Hills, California, with publication in a medical journal to follow.
The FDA has granted the IDx-DR system expedited review under the regulator’s Breakthrough Device program. Abràmoff and others at IDx expect the FDA will make their decision on the AI diagnostic later this year.
According to IDx, the device has the potential to be the first autonomous AI diagnostic approved for use in primary care.
“This technology has great utility and would be solving a real problem,” said Dr. John Parker, 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.”
Ten sites across the US were involved in the clinical trial of IDx-DR, which used real world data to assess the diagnostic. Non-clinician staff were the primary operators of the AI-based tool and were provided with four hours of training prior to commencing the study.
Currently diabetic retinopathy – including macular edema – is diagnosed through an eye exam conducted by an optometrist or ophthalmologist. According to IDx, 85 percent of patients with diabetes will develop diabetic retinopathy over the next 20 years. Advanced screening using the IDx-DR AI-based system could help patients start treatment sooner to prevent vision loss.