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| RETeval DR device--Courtesy of LKC Technologies |
Point-of-care diagnostics company Welch Allyn and visual electrophysiology player LKC Technologies have signed an exclusive partnership for the former to distribute the latter's RETeval DR device, which screens for diabetic retinopathy (DR).
Under the terms, Welch Allyn will distribute the RETeval DR diagnostic device outside of the U.S. under the Welch Allyn brand. The target market comprises healthcare providers who focus on diabetic patients with an increased risk of sight-threatening diseases. The companies plan to roll out the device in the first quarter of 2015.
The device provides patients with a simple, fast, accurate and cost-effective way to be screened for sight-threatening diabetic retinopathy without having to leave their primary care office. Currently, patients are referred by their primary care physician to an ophthalmologist or optometrist, who will perform a retinal exam. RETeval DR doesn't require dilation of the pupil, unlike fundus photography, which optometrists use to create an image of the interior surface of the eye, reported Ophthalmology Times.
One of the advantages of the test is "that the entire test is performed undilated, which patients really like, and two, it's very fast," Dr. April Maa, the principal investigator, told Ophthalmology Times.
RETeval DR is a hand-held, electrophysiology-based, functional screening device. It takes just a few minutes to screen each patient for sight-threatening DR and clinically significant macular edema. Results are shown instantly on the device's screen, according to Ophthalmology Times. The results of a trial involving 467 diabetic patients at two U.S. Veterans Affairs Hospital Centers show that the average testing time for both eyes was 2.3 minutes per patient. No adverse events were reported. According to Ophthalmology Times, the device is currently under FDA review.
Based in Gaithersburg, MD, LKC Tech markets visual electrophysiology products in more than 50 countries. While its RETeval DR will be distributed by Welch Allyn, its RETeval Complete, which can test for a wider range of ocular diseases and conditions, will remain exclusive to LKC. Neither RETeval DR nor RETeval Complete is available for clinical use in the U.S. RETeval is approved for clinical use in Japan, Australia and Canada, and is CE marked.
- read the release
- here's the study poster
- get more from Ophthalmology Times