FDA clears Healthy.io's smartphone-based AI test for early-stage kidney disease

At-home diagnostics have been a crucial weapon in the war against the COVID-19 pandemic, and after proving their mettle on that battlefield, they’re now becoming the standard for routine medical care.

One such test newly cleared by the FDA, for example, brings early detection of kidney disease into the home, requiring only a patient’s existing smartphone and an artificial intelligence-powered app to run. The Minuteful Kidney test was developed by Healthy.io and comprises a standard albumin-to-creatinine ratio (ACR) test, which is typically used as one of the first indicators of kidney damage.

An ACR test measures the amount of albumin in the urine. Because consistently higher-than-average excretions of the protein are a primary and early symptom of kidney damage, the test can help diagnose chronic kidney disease in its earliest stages.

According to Healthy.io, the Minuteful Kidney test marks the first smartphone-based, at-home ACR test cleared by the FDA. It was given the OK to run on all current Android and Apple smartphones.

Healthy.io Minuteful Kidney

Once a patient receives the test kit in the mail, the Minuteful Kidney app guides them through the process of collecting a urine sample, swabbing it with a dipstick and placing the sample strip on the designated color board.

From there, the patient takes a photo of the strip on their phone’s camera, and the app does the rest. It uses colorimetric analysis, computer vision and artificial intelligence technologies to analyze the sample and return immediate results, automatically providing individuals and their healthcare providers with an assessment of albumin levels.

In a 2019 study of the test, the at-home option saw greater completion rates than in-clinic ACR testing—nearly 29% for the home test, compared to 18% for standard methods—with 89% of surveyed Minuteful Kidney users saying they preferred conducting the test in their own homes.

“We have the experience, results and regulatory assurances to fundamentally change how Americans monitor chronic conditions using their smartphone camera,” said Yonatan Adiri, Healthy.io’s founder and CEO. “In effect, Minuteful Kidney is a digital antidote that can help every person at risk dramatically decrease their probability of undergoing dialysis.”

The test previously received CE mark clearance in Europe and has already been adopted by the U.K.’s National Health Service as a go-to tool for early kidney disease diagnosis. In the 18 months since its launch, Healthy.io said the app has enrolled more than 540,000 NHS patients and saved the healthcare system around 2.5 million hours of dialysis per year.

And Minuteful Kidney has ventured even further afield: In April, it hitched a ride on the Ax-1 mission to the International Space Station, where astronauts will be able to use a version of the test—adapted to the challenges of capturing a urine sample in space—to monitor kidney function while very far from home.