DR screening software performs well in clinical tests
Positive results from validation study in 627 patients show IDx-DR software is ready for clinical use
An automated screening system for grading diabetic retinopathy (DR) patients for referral is ready to progress to clinical use following positive preliminary study results.
A validation study, involving 627 patients, compared automated grading using IDx-DR software against three independent retina experts. The grading software, which was granted a CE mark in 2013, showed high sensitivity and specificity, 87% and 89% respectively.
Primary investigator of the study, Professor Giel Nijpels, of the EMGO institute at VU University Medical Centre Amsterdam, said: “Current screening methods for diabetic retinopathy are becoming quite costly due to the rising prevalence of diabetes. Based on these results and the easy implementation in our daily clinical practice, I’m convinced that automated detection is a safe and cost-effective method providing a breakthrough in [diabetic retinopathy]-screening.”
President of IDx, Professor Michael Abramoff, of the University of Iowa, said: “IDx-DR is ready for use. From many scientific studies we know that it is safe. We’ve repeatedly shown that IDx-DR is highly sensitive and specific to detecting diabetic retinopathy in different ethnic groups, in different types of retinal cameras and across different countries.”The findings were announced at a meeting of the European Association for the Study of Diabetes’ Eye Complications Study Group in Turin, Italy.