Health at home: Healthy.io outlines scaling plans for smartphone CKD testing

For people with diabetes, chronic kidney disease (CKD) is just one of many long-term complications they can develop over the course of their lives, with studies showing the prevalence rising rapidly in communities around the world. low and middle income.

Enter health tech company Healthy.io, with its Minuteful Kidney at-home test. Following landmark clearance from the US Food and Drug Administration (FDA) in July, the Israel-based company is looking to expand its smartphone-based test that promotes early detection of CKD.

The test works 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 the urine, which can be an early indicator of CKD and is often referred to as a silent killer due to symptoms that only appear in the later stages of the disease.

“The link between diabetes and CKD is very strong,” says Paula LeClair, US Managing Director of Healthy.io. “Diabetes and hypertension are our two main markets, but we primarily work with US healthcare providers to support their diabetic population because of the close association.”

Before Healthy.io received FDA clearance, it conducted an experimental review board that resulted in the signing of 7 health plans across the United States, covering over 100,000 patients.

“One thing we expected, but were able to prove in our study, is that this test can make the same difference in a marginalized community as it does in affluent communities,” LeClair says.

“We always believed that introducing home healthcare and removing barriers would be successful, but to see it unfold is certainly a pleasant surprise. We’re extremely proud on the health equity side because we know that black Americans are four times more likely to live with chronic kidney disease and so we were able to do the work to show that it doesn’t matter where you live and no matter what cell phone you own, this test will have the same impact regardless of the result. »

The latest FDA clearance makes Minuteful the only test on the US market that allows patients to test — and receive results — at home. A previous 510(k) clearance received by the company in 2019, authorized testing for use of the iPhone 7 at the point of care by healthcare professionals. “Our new clearance is significant because the FDA has recognized Minuteful as a ubiquitous platform,” LeClair says. “We are now cell phone agnostic and we were able to prove to the FDA that every time someone does this test at home, regardless of their smartphone, the test will be passed over 97% of the time. The FDA also said we’re substantially equivalent to point-of-care testing, which is groundbreaking. »

Healthy.io’s priority is to ensure the technology is widely available to patients at home, especially older adults with diabetes, LeClair says. “We work with health plans in different ways. One is that there’s a new measure of quality coming out in the assessment of kidney health and the Medicare Advantage population is where we’re going to see a real concentration of people with diabetes, age 65 and older. This new quality metric indicates that everyone enrolled in one of the programs must take our test every year with a blood test, so we are really focused on finding a way to support these health plans and keep their members. in good health.

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