FDA Approves Smartphone-based Urinalysis Test Kit for At-Home Use That Matches Quality of Clinical Laboratory Tests

Mobile technology continues to bring clinical-grade medical laboratory testing into patients’ homes, as more do-it-yourself kits receive FDA approval

Recently, the federal Food and Drug Administration (FDA) approved a smartphone-based at-home urine test that enables patients with chronic diseases, urinary tract infections, or high-risk pregnancies to monitor their health using a testing method that’s as easy as taking a smartphone selfie.

This latest breakthrough is another example of how technology is making it possible to move clinical laboratory testing closer to patients—in this instance into their homes. But it’s also taking away some of the urine testing being performed by medical laboratories.

The Dip.io urinalysis test system from Israeli-based Healthy.io received FDA 510(k) clearance for prescription home use. The test is for the semi-quantitative detection of glucose, specific gravity, blood, pH and protein, as well as the qualitative detection of nitrite. Special conditions also mandate in vitro diagnostic use only, according to the 501(k) Substantial Equivalence Determination Decision Summary.

In 2016, the Dip.io testing kit received CE marking, a certification mark that indicates health, safety, and environmental protection standards for products sold within the European Economic Area. And it has International Organization for Standardization (ISO) 13485 certification, making it commercially available in the European Union and the United Kingdom.

“We are incredibly proud of [achieving] this landmark ruling,” Healthy.io Founder and CEO Jonathan (Yonatan) Adiri (above) told MobiHealthNews. “It’s the highlight in a year that has seen us achieve so many of the key tasks we set out to achieve. With seven leading medical partners worldwide, including the UK National Healthcare System [sic] and a growing product portfolio, we’re set to meet 100,000 patients this year.” (Photo copyright: CNBC.)﻿

Patients Can Take ‘Medical Selfies’

The kit is comprised of a:

Urine receptacle;

Single, individually wrapped Mission urinalysis reagent strip;

Color-board;

Smartphone app with backend cloud-based server; and,

User manual.

Combining a urine sample kit and testing strips with color recognition, computer vision, and artificial intelligence (AI) has enabled Healthy.io to offer patients the ability to take what it calls a “medical selfie.” The test kit achieved more than 99% usability across age groups from 18 to 80.

“The process for the user is very simple,” Adiri told VentureBeat. “We like to say ‘If you can text, you can test.’ The user simply opens the app and is walked through the process step by step—aided by our chatbot nurse named Emily.”

According to Adiri, “the user opens the kit, fills the cup, dips the stick, and, places it on our patented color-board. After waiting for 60 seconds (timed within the app) both the color-board and dipstick are scanned, similar to how a QR code is scanned. The image is normalized and data points are sent to our cloud, where they are classified into the correct clinical result.”

Adiri notes that one significant aspect of the Healthy.io device is it uses a standard urinalysis dipstick.

“It is important to first note that we haven’t tampered with the standard urine dipstick,” Adiri told VentureBeat. “It has been a tried and tested diagnostic tool for decades and is well established across many clinical pathways. We test for ketones, leukocytes, nitrites, glucose, protein, blood, specific gravity, bilirubin, urobilinogen, and pH. These indicators span a wide range of pathologies, from urinary tract infection to ketosis, kidney disease, health in pregnancy, and bladder cancer.”

The Healthy.io app integrates Dip.io (above) into the clinical process by automatically sending results to the patients’ electronic health records for physician review. The results may necessitate a follow-up clinical laboratory urine culture test to determine whether bacteria or other organisms are present in the urine. (Image copyright: Science and Enterprise.)﻿

Adiri told VentureBeat that his company will be bringing an albumin-to-creatinine ratio (ACR) test to market as well. He says the test is “critical” for as many as 76 million Americans with diabetes, hypertension, and other medical issues who undergo urine testing looking for signs of chronic kidney disease. Healthy.io is also planning to release a skincare test.

“We see a leap forward in smartphone hardware that happens roughly every four years. Our urinalysis product would not have been possible five years ago because the image quality of smartphone cameras simply wasn’t good enough,” he noted.

Other Clinical Lab Grade Urine-testing Kits

Healthy.io received the FDA’s 510(k) approval on July 18, 2018. And as of February, 2019, the company has raised $18 million in venture capital funding, according to VentureBeat, which reports that 100,000 patients in Europe and Israel are already using Dip.io.

“We know that most patients with kidney disease and protein in their urine are untested and therefore go undiagnosed,” Josef Coresh, MD, PhD, professor of epidemiology, medicine, and biostatistics at Johns Hopkins Bloomberg School of Public Health, and head of Healthy.io’s clinical advisory board, told VentureBeat. “[This] technology—[which] directly [connects] patients at home with the medical system—is a gamechanger addressing a big need.”

According to mHealth Intelligence, Dip.io is reportedly one of the first Class II medical devices the FDA has approved for use with optical equipment designed by a third party, such as a smartphone.

But it’s not the only at-home clinical-grade urine testing kit in the market. California-based inui Health, formerly known as Scanadu, announced the launch of its own clinical-grade home urine analysis platform last year. Its FDA-approved kit includes a dippable paddle that measures five key biomarkers (protein, glucose, leukocytes, nitrites, and ketones) in urine and uses a smartphone app to provide results directly to patients within one minute. Results may be shared with providers via a HIPAA compliant system.

As more diagnostic tests become available for home-use, anatomic pathology and clinical laboratories should work closely with healthcare providers to ensure patients who use these new tools receive the proper interpretation guidance and follow-on diagnostic or monitoring tests they need.

The flood of new diagnostic technologies undergoing research and moving toward regulatory approval should motivate medical laboratory managers and clinical pathologists to rethink their lab’s business and clinical strategies. The goal would be to identify ways to offer these new diagnostic tools so that labs can deliver more value to physicians, patients, and payers—value for which clinical labs can be reimbursed under new payment models.

—Andrea Downing Peck

Related Information:

Healthy.io Gets FDA Nod for Smartphone Camera-based Home Urine Test

501(K) Substantial Equivalence Determination Decision Summary

Healthy.io Turns Your Smartphone into a Clinical-Grade Medical Testing Device

A Big Win for Digital Health: U.S. FDA Grants Landmark Class II Approval for Clinical Grade Smartphone Test—Healthy.io’s Dip.io Urinalysis

FDA Approves Smartphone-based mHealth Platform for Urinalysis Test

inui Health Announces the First Clinical Grade Diagnostics Test Accessible to Everyone, Anywhere in the World, from Their Smartphone

FDA Approves Smartphone Camera-based Dipstick Product

At-home, Smartphone-based Urine Testing Now a Clinical Reality

FDA Letter to Healthy.io Ltd.

Healthy.io Raises $18 Million for At-Home Urinalysis Tests