Last year, Healthy.io claimed FDA approval for the first smartphone-based, at-home diagnostic that can be used to screen people for chronic kidney disease (CKD). Now, Boehringer Ingelheim has come on board to see how the test might be used more widely to improve patient care.
The Minuteful Kidney test provides a way to carry out the standard albumin-to-creatinine ratio (ACR) test, which detects protein in the urine and can provide an early warning that a person is starting to develop kidney disease.
It takes the form of a test kit that is received in the mail, combined with a mobile app that guides users through the process of collecting a urine sample, swabbing it with a dipstick and placing it on a color board ready to be photographed using a smartphone camera.
The app uses colorimetric analysis, computer vision and artificial intelligence technologies to assess the sample and give an immediate readout that can be shared with healthcare providers.
With Boehringer’s help, Healthy.io plans to examine the “operational aspects” of using the kit in people’s homes at scale to support early detection of CKD, which is sometimes called the “silent killer” because it often doesn’t cause symptoms until the very late stages.
Currently, the low rate of ACR testing in the U.S. is a major impediment to providing patients with the care they need. According to guidelines, all people in the at-risk category should have an annual test, but only around 20% actually do so.
“Increasing test-adherence rates across all demographics and socio-economic groups leads to earlier detection of CKD and provides a path to care for those who need it,” said Healthy.io’s U.S. general manager Paula LeClair in a press release.
“This is a true win—better health outcomes for patients, as well as potentially reduced healthcare costs,” she added.
Boehringer has a horse in the race when it comes to identifying people who are at risk of CKD. The drugmaker is waiting for an FDA decision on its SGLT2 inhibitor Jardiance (empagliflozin)—partnered with Eli Lilly—as a treatment to reduce the risk of kidney disease progression and cardiovascular death in adults with the disease.
Jardiance is already approved for diabetes as well as heart failure and is the top-selling drug in the class with sales reaching a massive $6.3 billion last year.
In CKD it is playing catch-up with AstraZeneca’s SGLT2 drug Farxiga (dapagliflozin), which is already approved for that indication after getting a green light from the FDA last year. Boehringer and Lilly are now looking to close the gap and filed for approval in January. The U.S. regulator is due to deliver its verdict on Jardiance in the second half of this year.
Boehringer said the Healthy-.io collaboration could help to increase testing for CKD so that those at risk can be evaluated for the appropriate care management.
“Early screening and diagnosis is critical in delaying CKD progression, and may help reduce the potential for serious complications down the road,” said Lennart Jungersten, head of medicine and regulatory affairs at Boehringer Ingelheim Pharmaceuticals.
AZ meanwhile has also turned to medtech to support the development and use of therapies for CKD. It is working with Health2Sync on a digital support program for patients already diagnosed with CKD and is using a digital testing device developed by ImpediMed to measure fluid status and tissue composition in its CKD clinical trials as an alternative to conventional lab testing.