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The start-up Healthy.io has received marketing authorization for their Minuteful Kidney home test capable of detecting early kidney damage and receiving biological results in a few moments. Explanations.
It is the first home test capable of giving biological results without going through a medical analysis laboratory which is approved by the American authorities, the Food and Drug Administration (FDA). Available on all current iOS and Android smartphones, Minuteful Kidney allows you to determine the albumin to creatinine ratio (ACR), by performing a simple urine dipstick test at home.
An authorization that comes after that of the United Kingdom
The clearance comes after Healthy.io was also adopted by the National Health Service (NHS) in the UK as its main AI tool for early warning of kidney damage.
According to the company, over the past 18 months, Minuteful Kidney has “enrolled over 540,000 people in the UK and saved the NHS 2.5 million hours of dialysis a year”.
Results received on smartphone
The test to be performed to obtain its results is relatively simple. After collecting your urine, you simply have to dip the strip then place it near the tool for reading the results. A simple photo to take and send via the application is enough to get a feedback on the results. In particular the albumin to creatinine ratio, which will be classified as normal, abnormal or highly abnormal, depending on the case.
A recommended test for 75 million Americans
Until now, the ACR test could only be performed by a doctor in the United States. Yet it is recommended for more than 75 million Americans at risk of chronic kidney disease. Indeed, by detecting the presence of albumin in the urine, this allows the doctor to evoke the possibility of renal failure which sets in the patient.
In the United States, one in three people is at risk, but most are still too little informed about the risks of triggering kidney failure. Pathology favored by several risk factors: obesity, high blood pressure, cholesterol, diabetes, etc.
Minuteful Kidney has received 510(k) clearance from the FDA, across all current iOS and Android smartphone devices. This is the first time the FDA has cleared a smartphone-powered home ACR test, holding promise for 60 million at-risk Americans. https://t.co/6XDA2mXbPW pic.twitter.com/T7zFRZ7ho0
— Healthy.io (@Healthyio1) July 12, 2022
A lack of prevention still too great
“Indeed, it is not uncommon for us to receive patients who have already reached the pre-dialysis stage” confirms Dr. Prisca Mutinelli-Szymanski, nephrologist at AURA and Bichat Hospital in Paris. “This application can bring a real plus to American patients, who could have access to medical results at a lower cost. In France, this urine dipstick test is carried out in occupational medicine. But prevention must still be put forward. Our only tools for detecting silent diseases such as chronic kidney failure are biological tests” adds the specialist, who pleads for an app that would serve as a reminder for patient monitoring. “This is a good step forward, the only downside is that the strip technique does not diagnose all kidney diseases”.