90% of kidney disease is undiagnosed – here's how we might fix it

Diagnostics, prognostics, at-home testing, and the case for universal CKD screening

Sep 25, 2023

There are currently 850 million people in the world living with chronic kidney disease (CKD), and CKD is predicted to become the fifth global cause of death by 2040.

90% of people with kidney disease don’t even know they have it. Neither do their doctors.1 Early stage CKD has few symptoms, if any. The good news: it can be identified with simple tests. The bad news: too few people actually get tested.

While debates continue here in the US around the cost-effectiveness of routine CKD screening for certain age groups and at-risk populations, data suggests preventing progression to kidney failure can save more than $300,000 per patient, while also improving (and extending) quality of life.23

Today we take a closer look at 3 companies tackling these challenges head-on, and recent data that suggests regular CKD screening may (finally) make sense.

IN THIS ISSUE

Carenostics raises $5M seed round led by M13
Renalytix receives FDA De Novo for KidneyIntelX
Healthy.io raises $50 million to enable US expansion
Routine screening for CKD might (finally) be cost-effective
Why it matters and what’s next in this space

1. Carenostics raises $5M seed round led by M134

Carenostics is building a clinical decision support platform that integrates with provider EHR data to identify high-risk, undiagnosed chronic disease patients and activate clinicians to intervene earlier.

At Hackensack Meridian Health in New Jersey, Carenostics' platform has identified up to 3x more chronic kidney disease (CKD) patients and up to 20x more severe and uncontrolled asthma (SUA) patients, while maintaining a 5x lower false positive rate than current care practices.
For father-son duo Bharat and Kanishka Rao, this problem is deeply personal: They started the company after Kanishka’s grandfather succumbed to undiagnosed CKD.
The company also recently welcomed two industry veterans to its Advisory Board in Kurt Hilzinger (Chairman of Humana) and Dr. John Glaser (Cerner, Siemens, Partners).

Milestones: The team has 60+ healthcare AI patents, 200+ peer-reviewed paperers in healthcare AI, 20+ products launched through FDA and PMA approval, and 300+ US health system deployments to date.5

2. Renalytix receives FDA De Novo for KidneyIntelX6

Renalytix (LSE: RENX) (NASDAQ: RNLX) is a developer of AI-enabled clinical in vitro diagnostic solutions for kidney disease.

The KidneyIntelX test relies on an artificial intelligence (AI) algorithm to look for certain biomarkers in a patient’s blood sample and to analyze a handful of additional data points collected in their EHR.
The AI’s findings are presented as a risk score that suggests whether an individual patient is at a low, moderate or high risk of experiencing a progressive decline in kidney function within the next five years.
The company first submitted the KidneyIntelX test platform to the FDA for review in August 2020, about a year after earning breakthrough-device designation.
Their lab-developed test (LDT) launch began at Mount Sinai Health System in New York, which is where the technology was first developed before being licensed to Renalytix.

Milestones: As of June, the LDT version of the test had been used with about 10,000 patients in the US.7

3. Healthy.io raises $50 million to expand smartphone kidney test in US market8

Healthy.io uses colorimetric analysis, computer vision, and AI to transform smartphone cameras into a clinical-grade medical device. They developed the Minuteful Kidney™ test to make at-home urine testing possible.

In 2022 the company received 510(k) clearance from the FDA for home use of the Minuteful Kidney™ test. It’s the first time the FDA has granted clearance for a smartphone-based home test to determine ACR.9
An ACR test is currently recommended for the 75 million Americans at risk for Chronic Kidney Disease (CKD). Until this clearance, the test could only be conducted by a medical practitioner. As a result, 60 million Americans fail to complete their annual test. That’s roughly 80% of at-risk patients!
Last year the team landed their first US commercial contract with Blue Cross of Idaho. In May, they announced a partnership with Boehringer Ingelheim.1011
To date the company has raised $188 million in outside capital, has logged over 1 million scans and engaged more than 1.2 million patients.12

Milestones: Minuteful Kidney has raised testing adherence up to 50% at scale across previously untested populations, irrespective of demographic and socioeconomic differences.

4. Routine screening for kidney disease might (finally) be cost-effective13

In 2012, the US Preventive Services Task Force (USPSTF) convened to determine whether it should recommend kidney disease screening for all Americans— there wasn’t enough evidence to say if screening was a net good.

In recent years the entry of new drugs (SGLT2 inhibitors) in kidney care has shifted the economic calculus of screening.14
Using existing data and a model to extrapolate results to the full U.S. population, researchers found one-time screening and use of SGLT2 inhibitors could keep nearly 400,000 people from going on dialysis or needing a kidney transplant in their lifetime.15
Further, screening every five years, plus SGLT2 inhibitors, could prevent about 658,000 people from needing dialysis or transplant compared with the status quo.

Milestones: Decades in the making, progress! In July the USPSTF released its Final Research Plan for CKD screening (see below).16

Why It Matters

More than 37 million Americans are estimated to have chronic kidney disease. Kidney care accounts for 1 in 5 Medicare dollars.17

Reliance on the current eGFR threshold to diagnose CKD means that by the time CKD is diagnosed, over 50% of the functional kidney mass has been lost and the combined risk of CKD progression and premature death is already increased by around 2- to 7-fold.18

Kidney disease disproportionately affects communities of color. Black or African Americans are almost four times more likely to have kidney failure compared to White Americans.19

Kidney disease is not unique in having a clear difference among ethnic groups with respect to risks and outcomes. The same can be said for many chronic diseases including diabetes, heart failure, peripheral arterial disease, asthma, and cancer, as well as for pregnancy.20

Addressing the underdiagnosis, undertreatment, and health inequities in kidney disease is critical. As Dr. J. Kevin Tucker wrote in a February, 2021 Harvard Health blog:

It will take patients, families, clinicians, and community health advocates working cooperatively to eliminate disparities in rates of CKD and its outcomes.

What’s Next

The US healthcare system is plagued by chronic disease, which is the leading cause of death and disability in the US and drains a staggering 90% of the roughly $4.1 trillion in annual healthcare spend.21 A significant portion of these outcomes and expenses are driven by undiagnosed chronic disease patients being treated too late.22

A contributing factor to late diagnosis and treatment is overburdened physicians. A recent study from the Journal of General Internal Medicine showed that it would take 27 hours each day for a doctor to follow all acute, chronic and preventive guidelines.23

It’s time to rethink our approach to early detection and treatment. In the not too distant future, will early diagnosis becomes the norm rather than the exception? People may never learn about kidney disease, but will they understand their kidney health?

The weight of the world is in the balance.

What are your thoughts on this Signal? What did we miss, and what else should people know? If you’re building something in this [space], I’d love to meet you.