At-Home Test for Kidney Disease Gains FDA Clearance

People with diabetes or hypertension are more likely than those without those conditions to develop chronic kidney disease (CKD), but many are either unaware of their risk status or fail to make appointments for screening that might lead to a diagnosis.

Soon, though, they may be able to screen themselves at home using a new digital therapeutic.

The digital therapeutics maker Healthy.io gained clearance from FDA last month for its at-home kidney test. The clearance means the company is free to market the product in the U.S.

The company’s test measures the albumin-to-creatinine ratio (ACR) in a patient’s urine. Annual ACR testing is recommended for people at risk of CKD. Early detection of the disease can allow time for interventions to slow or prevent further kidney damage.

“Millions of Americans are living with kidney disease, yet many don't know they have the condition,” said George Bakris, M.D., who directs the Comprehensive Hypertension Center at the University of Chicago, in a press release. “An albumin test is required for proper diagnosis, and an important tool to monitor kidney health for those at risk.”

Aside from the at-home test, patients typically need to go to a physician’s office to obtain an albumin test. The company said the fact that patients need to go to a provider for testing means most people who qualify for annual testing — about 80% of high-risk patients — do not actually complete their tests each year.

Healthy.io’s product, which it is called Minuteful Kidney, aims to solve that problem by bringing the process into the patient’s home. Patients receive a testing kit in the mail and perform their urine test using a testing strip provided in the kit. Then they use a smartphone’s camera to read the results from the strip. The company’s app uses colorimetric analysis, computer vision and artificial intelligence to interpret the results. Those results can then be immediately shared with the patient’s healthcare provider.

The company said its clinical evaluation studies with U.S. insurers have shown testing adherence jumped to as much as 50% in untested patients when patients were given the at-home testing option. Those findings applied across socioeconomic and demographic groups, they said.

The FDA clearance could result in an expansion of at-home testing availability. Healthy.io said it is ready for a fast commercial rollout, in part because the company already has a significant track record in the United Kingdom, where the National Health Service adopted the tool four years ago. In the intervening years, some 140,000 people have used the test, the company said. Healthy.io said 55% of British patients who were considered at-risk for CKD but who had not tested the previous year used their at-home test.

“In effect, Minuteful Kidney is a digital antidote that can help every person at-risk dramatically decrease their probability of undergoing dialysis,” said Yonatan Andiri, Healthy.io’s founder and CEO.

The company calculates that their service could help avoid some 19.8 million hours of dialysis among the 1.4 million people with diabetes living in the United Kingdom who are currently untested, a cost savings of nearly £700 million.

In the U.S., the company noted, end-stage renal disease costs the Centers for Medicare and Medicaid Services some $120 billion each year to treat Medicare patients.

Ron Zohar, Healthy.io’s chief product officer, said this clearance is the result of nearly a decade of scientific investigation.

“"The work conducted in collaboration with the leadership at the FDA's Center for Devices and Radiological Health facilitated the development of AI innovation that will now deliver better digital health to the American public,” he said, in the press release. “We look forward to expanding our work with US payers and insurers in making sure every American with a smartphone can access this state-of-the-art technology."