Around 1 in every 8 people in the U.K. will develop chronic kidney disease, according to the British Kidney Patient Association. Moreover, 19 people in the U.K. experience kidney failure every day, and those patients contribute to the £1.45 billion ($1.93 billion) the National Health Service (NHS) spends treating chronic kidney disease each year.
Those sobering statistics were the catalyst for Healthy.io‘s Dip.io, an at-home digital testing kit that enables patients to collect and analyze urine samples with nothing more than a smartphone app, a dip stick, a color-coded slide, and a dash of artificial intelligence. Healthy.io, which is under the wing of the NHS Innovation Accelerator program, launched today as part of the Salford Royal NHS Foundation Trust’s Digital Exemplar program. A group of 50 patients will participate in what the health service is calling the Salford Royal Virtual Renal Clinic.
Dip.io is designed with ease of use in mind, CEO and cofounder Yonatan Adiri told VentureBeat in a phone interview. Patients follow the instructions, wait for the colors on the included dipstick to develop, and take a picture of it against a color card with the companion smartphone app, after which the image is whisked away to be analyzed. Healthy.io’s machine learning algorithms then determine if a prescription or appointment might be needed. (Adiri is careful to point out that Healthy.io is compliant with the GDPR, Europe’s wide-ranging privacy legislation, and that medical records are anonymized and tokenized so as to protect users’ identities.)
In a triple-blind study with 500 subjects, 99 percent of people were able to complete a test, Adiri said.
Healthy.io’s medical-grade CE and ISO 13485 certified-for-sale kit performs urinalysis for a range of illnesses, infections, and pregnancy-related complications. Specifically, it tests for ketones, leukocytes, nitrites, glucose, protein, blood, specific gravity, bilirubin, urobilinogen, and pH, markers that span pathologies from urinary tract infections to ketosis, kidney disease, pregnancy health, and bladder cancer.
For patients, the benefits are obvious: Taking snapshots of urine samples is much less of a hassle than driving to a nearby hospital, which in turn improves adherence rates. In the U.S., less than 10 percent of patients in the early stages of chronic kidney disease — which often aren’t associated with symptoms — are aware they have the illness.
As for clinicians, at-home tests like Dip.io thin out waiting rooms and help hospital staff prioritize urgent cases. “If you look at the exponential growth around the smartphone camera … it makes sense to leverage this growth to [use] it for diagnostic purposes,” Adiri said. “[Patients] don’t have to go to the lab anymore,” he added.
Healthy.io’s kit already covers 6 million people in the Tel Aviv-based company’s home country of Israel, and the team plans to expand to the Netherlands. The company has also completed an FDA 510k submission in the U.S., where it expects to receive clinical approval for Dip.io by the end of 2018.
“This is great news for patients with kidney conditions, and we’re really excited to be the first NHS organization to be trying out this smartphone camera testing,” Dr. Jim Ritchie, consultant kidney physician at Salford Royal NHS Foundation Trust, said in a statement. “We’re hoping this will not only make it easier for patients but will empower them to share responsibility for their overall health.”