New Study at ASN Kidney Week Showcases the Accuracy of Smartphone-Enabled uACR Testing for Chronic Kidney Disease

New data shows the at-home FDA-cleared test, Minuteful Kidney, exceeded the recommended precision threshold for the industry

BOSTON, Nov. 14, 2024 /PRNewswire/ — Healthy.io, the global leader in transforming the smartphone camera into a medical device, announced the results of a new study at the American Society of Nephrology’s ‘Kidney Week’ in San Diego. The research, conducted by Birdrock Laboratories, a San Diego based analytical laboratory in collaboration with Dr. Navdeep Tangri from University of Manitoba, set out to assess the accuracy of the smartphone-enabled urinary semi-quantitative albumin-to-creatinine ratio (uACR) tests compared to the quantitative laboratory test. Healthy.io’s Minuteful Kidney Test is the first and only smartphone-powered FDA-cleared at-home uACR test. The study demonstrated 96.4% sensitivity for identifying markers for chronic kidney disease against the laboratory test.

The Minuteful Kidney Test’s accuracy was evaluated in comparison to the Beckman Coulter AU 480 analyzer, a gold-standard laboratory quantitative method, for detecting albuminuria in individuals with or at risk for CKD. The study analyzed 615 urine samples from outpatient settings in economically diverse areas, all of whom showed one of the risk factors for kidney damage, including diabetes, hypertension, cardiovascular disease, a personal history of AKI, a family history of CKD, inherited kidney diseases, early-stage CKD, dyslipidemia, obesity, and other relevant conditions.

Albuminuria, an early signifier of CKD, was detected in 24.9% of samples using the quantitative gold-standard analyzer. The Minuteful Kidney Test demonstrated very high accuracy rates with 96.4% sensitivity and 84.2% specificity. The guideline-recommended threshold for sensitivity of this type of test is 85%. Ultimately, the study demonstrates that the Minuteful Kidney Test is an accurate tool for albuminuria testing that can address key barriers and significantly improve CKD testing and management, bridging the gap in current healthcare practice guidelines.

“When trying to solve the CKD crisis, it’s important that we start upstream and identify individuals early who may be at risk before complications arise,” said Geoff Martin, CEO of Healthy.io. “Widespread use of the Minuteful Kidney home test for albuminuria can significantly mitigate the problem of under-detection, ultimately saving millions of lives and getting people to care earlier to delay or ideally reduce the need for transplant or dialysis”

An estimated 37 million U.S. adults have CKD, a leading cause of death in the U.S., yet most remain undiagnosed and 9 out of 10 Americans don’t know they have the disease. uACR testing is crucial for diagnosing, staging, and managing CKD. Still, despite clinical guidelines, adherence rates of testing remain low, with only 20% of the population at risk routinely testing.

A uACR test detects albuminuria, which is the earliest indication of kidney disease. Getting a diagnosis early is key to preventing complications like End-Stage-Renal-Disease and cardiovascular disease.

The FDA-cleared smartphone-powered home test offers accurate, convenient, cost-effective uACR analysis that can overcome access barriers. New treatments are now available that can stop or slow down the progression of CKD, and given limitations and difficulties for many individuals in accessing laboratory facilities, these tests can accelerate the identification of individuals at risk of CKD, particularly for socially marginalized communities so that they are referred or treated before it is too late.

״Lack of albuminuria testing is the single biggest barrier in the fight for upstream intervention in CKD”, said Dr. Navdeep Tangri from University of Manitoba. “Having an accurate at-home test like Minuteful Kidney helps patients and physicians move the needle on this challenge and be more proactive in CKD care.”

About Healthy.io

Healthy.io transforms the smartphone camera into a medical device to deliver healthcare at the speed of life. The company’s at-home urinalysis and digitized wound care services enable providers and healthcare systems to close gaps in access and care while increasing patient satisfaction. Healthy.io is a global leader in digital health and received the 2024 Digital Health Hub Award for ‘Best in Class – Home Health Diagnostic’ at HLTH, and the 2023 MedTech Breakthrough Award for ‘Best In-Home Testing Solution’. The company has offices in Boston, London, and Tel-Aviv.

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SOURCE Healthy.io