Geisinger launches clinical trial to test urinalysis app
Geisinger Health System has teamed with the National Kidney Foundation and an Israeli startup Healthy.io to launch a clinical trial to study the efficacy of smartphone-enabled urinalysis kits used at home by patients with hypertension to detect chronic kidney disease.
The clinical trial, which starts this month, will include 1,000 non-diabetic patients with high blood pressure who will be randomized into two 500-person groups—one will receive traditional care, and the other will receive a Healthy.io urinalysis kit in the mail, along with instructions for downloading the app.
“Early detection of kidney disease is difficult because a lot of times patients aren’t screened for it,” says Alexander Chang, MD, a practicing nephrologist and assistant professor in the Kidney Health Research Institute at Geisinger. He contends that the smartphone app from Healthy.io will enable study participants to conduct a urinalysis test at home and securely share the results with their clinicians via a HIPAA-compliant server in the cloud.
According to Healthy.io, its urinalysis kit—which utilizes a dipstick and the smartphone’s camera—is as accurate as the standard lab-based analyzer for detecting the presence in urine of albuminuria—a type of protein that is indicative of kidney disease.
“This tech company in Israel has used some pretty cool technology,” adds Chang. “Most people have smartphones these days, and one of the features of smartphones that are extremely sophisticated is the camera, which is used to capture data. The app has you take a picture of the urinalysis dipstick.”
“Many different smartphone cameras and infinite lighting conditions make accurate dipstick reading highly challenging,” states the Healthy.io website. “However, our computer vision algorithms and unique calibration method make accurate testing as easy as taking a selfie.”
While the product is CE and ISO 13485 certified for sale in the European Union, it is still awaiting clinical approval in the United States after a 510k submission to the U.S. Food and Drug Administration.
Patients with high blood pressure have been targeted for enrollment in the study because hypertension is a contributing risk factor for chronic kidney disease (CKD).
“This new trial using a smartphone app and urinalysis kit will provide important information on how to increase testing for CKD in this high-risk population,” said Kerry Willis, chief scientific officer for the National Kidney Foundation. “Our hope is that a home-based test makes it easier for patients at risk for CKD to comply with regular albuminuria screening, and that this will lead to earlier diagnosis and treatment of CKD, reducing cardiovascular risk and preserving kidney function.”