Healthy.io’s Smartphone-Powered Minuteful Kidney Test Gets FDA Clearance

The Minuteful Kidney test is Healthy.io’s most recent innovation that has acquired 510(k) clearance from the US Food and Drug Administration (FDA). It has become the first-ever digital home kidney test to enable early warning of kidney disease.

Chronic kidney disease (CKD) happens when the kidneys are damaged and are unable to efficiently filter wastes from the blood. Some factors that can increase the risk of CKD include diabetes, hypertension, cardiovascular disease, smoking, obesity and a family history of kidney disease. Around one in three adults in the US (or about 80 million Americans) are at risk of developing CKD. Approximately 90 percent of people with kidney disease are unaware of their condition.

Patients with end-stage kidney disease need to undergo regular dialysis which has an in-center treatment time of three to five hours and is usually done three times a week. The alternative option for patients with end-stage kidney disease is a kidney transplant.

Blood and urine tests such as the albumin to creatinine ratio (ARC) and glomerular filtration rate (GFR) are widely used for the detection of abnormalities in kidney function. The ACR is used to detect the increased excretion of albumin in urine, which is an indicator of kidney damage. Usually, the urine sample of the affected individual is collected over a period of four to 24 hours to test the level of albumin present.

A yearly ACR test helps detect kidney disease early, but unfortunately around 80 percent of people at risk for kidney disease do not complete the annual test. Therefore, that adds up to around 60 million Americans who are untested and at high risk of kidney disease and kidney failure.

There is no doubt that we are already in the digital health era and that smartphones are being thought of as tools to accelerate healthcare delivery. Healthy.io is a leader in transforming the smartphone camera into a medical device that can help diagnose a disease without a visit to a laboratory.

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Healthy.io’s Minuteful Kidney Test: An Innovative Home Kidney Test

The Minuteful Kidney test facilitates the detection of abnormal albumin levels in the urine of an individual at their home. This test quantifies the ratio of microalbumin and creatinine present in the patient’s urine sample.

The main goal of this home kidney test is to encourage patients with pre-existing conditions such as diabetes or high blood pressure to test themselves to help detect the early onset of any abnormalities in kidney function. An early diagnosis would help avoid end-stage kidney disease.

The Minuteful Kidney test sharply increases testing adherence because it is easy to use, and patients can use the test at home at their desired time and get immediate results.

According to Healthy.io, four single arm observational studies in the UK that focused on diabetic people who were not following standard ACR testing revealed that the proportion of patients getting a positive (abnormal or high abnormal) test result ranged from 23 percent to 25 percent. Between 92 percent and 98 percent of users found the Minuteful Kidney test easy or very easy to use, and 84 percent to 97 percent indicated a preference for home testing.

“Millions of Americans are living with kidney disease, yet many don’t know they have the condition. An albumin test is required for proper diagnosis, and an important tool to monitor kidney health for those at risk. Healthy.io has provided an easy way to provide patients and clinicians with potentially life-saving information,” said George Bakris, MD, Director of the Comprehensive Hypertension Center, University of Chicago and the American Diabetes Association, in Healthy.io’s press release.

The Minuteful Kidney test kit is delivered to the patient’s home and is made up of all these things needed for in vitro home ACR testing:

• A urine collection cup
• An ACR urine reagent dipstick/strip
• An absorbent pad to remove excess liquid from the reagent strip
• A color board that allows for image recognition

The patient also needs to have an Android or iOS smartphone that meets the minimum hardware criteria for the ACR app. The healthcare provider will send a text message to the patient to invite them to download the ACR app. This mobile app has image recognition software which enables a smartphone to analyze the ACR urine strip by using a software algorithm, computer vision and colorimetric analysis.

The Minuteful Kidney test is three to five minutes long and the following steps must be followed by the patient:

1. After receiving the kit, the patient collects a urine sample in the collection cup.
2. The reagent strip is dipped into the urine sample for one second and any excess liquid is removed using the absorbent pad.
3. The strip is placed on the color-board and after 60 seconds the color-board is scanned using the smartphone in order for the software algorithm to analyze the scanned image.
4. The ACR results will appear on the mobile app and will also be automatically and securely sent to the general practitioner (GP). The patient will be contacted by the GP if there is an abnormality in the test result.

“Healthy.io has worked for almost a decade on a series of scientific breakthroughs that have facilitated a dialogue of trust with the FDA,” said Ron Zohar, a member of the founding team and Chief Product Officer of Healthy.io in the company’s press release.

“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. 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,” added Zohar.