For people living with diabetes, chronic kidney disease (CKD) is just one of the many long-term complications they can develop in their lifetime, with studies showing the prevalence rises rapidly in low- and middle-income communities.
Enter health technology company Healthy.io, with its home-based Minuteful Kidney test. Following a landmark clearance from the U.S. Food and Drug Administration (FDA) in July, the Israel-headquartered company is looking to scale its smartphone-based test that promotes early detection of CKD.
The test functions by allowing patients to take a clinical-grade albumin-to-creatinine ratio (ACR ) urine test at home using a smartphone camera, with results delivered immediately. The ACR test looks for albumin in urine, which can be a leading indicator for CKD and is often referred to as a silent killer due to symptoms not surfacing until the late stages of the disease.
“The link between diabetes and CKD is very tight,” explains Healthy.io US general manager Paula LeClair. “Diabetes and hypertension are our two primary markets but first and foremost, we are working with U.S. health providers to support their diabetes population because of the tight association.”
Before Healthy.io received the FDA home clearance, it conducted an investigational review board which resulted in signing up 7 health plans across the U.S., spanning over 100,000 patients.
“One thing we expected but we’ve been able to prove in our study, is that this test can make the same difference in a marginalised community as it can in affluent ones,” says LeClair.
“We always believed that bringing healthcare into the home and removing barriers would be successful but seeing it played out is certainly a pleasant surprise. We are extremely proud on the health equity side of the story because we do know that Black Americans are four times more likely to be living with CKD and so we were able to do the work to show that it doesn’t matter where you live and it doesn’t matter what cell phone you have, this test will have the same impact regardless.”
The latest FDA clearance makes Minuteful the only test on the U.S. market to allows patients to test – and receive results – at home. A previous 510(k) clearance received by the company in 2019, cleared the test for healthcare professionals point of care use with the iPhone 7. “Our new clearance is significant because the FDA recognized Minuteful as a ubiquitous platform,” says LeClair. “We are now cell phone agnostic, and we were able to prove to the FDA that every time somebody does this test at home, no matter what smartphone they have, over 97% of the time the test will be completed successfully. The FDA also said that we’re substantially equivalent to the point of care tests which is groundbreaking.”
Healthy.io’s priority is ensuring the technology can be accessed broadly by patients at home, particularly any elderly people living with diabetes, says LeClair. “We’re working with health plans in a couple of different ways. One is that there is a new quality measure coming out in kidney health evaluation and the Medicare Advantage population is where we’re going to see a real concentration of people living with diabetes, who are aged 65 years old and up. This new quality measure says anybody in one of the programs needs to complete our test every year along with a blood test, so we’re focused on really finding a way to support these health plans and keep their members healthy.”