Chronic Kidney Disease

Kidney’s Role in Systemic Health

The kidneys are responsible for several key biological functions that help support good health.

Graphic highlighting major causes of kidney disease including diabetes, heart disease, high blood pressure, 60+ years of age, obesity, smoking and tobacco use, family history, and kidney injury.

Chronic Kidney Disease (CKD) occurs when the kidneys are damaged over time and become less effective. In the body, glomerular filtration produces proximal tubular secretion removing the waste product creatinine from blood via the kidneys. Creatinine, a byproduct of the process by which muscle tissue derives energy from the chemical creatine, is then eliminated from the body through urine, both indicators of reduced kidney function. 

A variety of factors lead to CKD, given its role in the body. For example, diabetes impairs the body's ability to process glucose. Over time, elevated sugar can damage kidney blood vessels, reducing blood flow and contributing to CKD. Similarly, high blood pressure narrows blood vessels, including those in the kidneys, further promoting CKD¹. Currently, 75% of kidney failure cases in need of dialysis are associated with diabetes or high blood pressure.

CKD By the Numbers

The rise in CKD and its risk factors, such as diabetes² and high blood pressure³ demands innovation in diagnostic and treatment options to address this growing public health crisis.

1 in 3 US adults are at risk for kidney disease. ⁴

1 in 7 US adults have kidney disease. 90% don’t know it. ⁸

CKD is the third fastest-growing cause of death worldwide. ⁹

Nearly 700 million people worldwide have CKD. ⁵ ⁶ ⁷

Current Diagnostic Standard Lacks Precision Needed for Early Diagnosis

The process of diagnosing CKD can be burdensome and time-consuming for both healthcare professionals and patients. The current diagnostic standard is estimated GFR (eGFR), a blood test used to estimate serum creatinine concentration via a complex diagnostic equation. Due to its imprecision, eGFR is often assessed in combination with other tests (blood urea nitrogen (BUN) and creatinine clearance test (CrCl)), which require additional blood and urine samples and further interpretation.

TRACE-E logo

Current Diagnostic Standard

Burden of blood draw and 24 hour urine collection
Non-invasive, convenient breath test
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Patient Comfort

Complex diagnostic equation to interpret eGFR and CrCI
Early stage disease breath biomarkers in 90 seconds
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Time & Complexity

28% sensitivity (>45ml/min) and 94% specificity (>45ml/min) for eGFR
90% sensitivity and 99% specificity for breath biomarkers
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Sensitivity & Specificity

Trace Sensing’s Commitment to Enhancing CKD Screening

Trace Sensing’s approach combines unprecedented sensitivity with a patient-centric technique by measuring CKD biomarkers in exhaled breath. Disease induces genetic mutation, translational errors, and environmental stressors creating proteomic biomarkers.¹⁰ ¹¹ Unlike proteins, VOCs reflect the change in the function of the affected organ.¹² ¹³ ¹⁴ Together, proteins and VOCs are transported from the blood to air in the lungs and exhaled creating a distinct biomarker profile for disease in breath.

In the case of CKD, as the kidneys become less effective, increased levels of creatinine circulate in the blood as well as a distinct pattern of VOC’s. In our preliminary research, we have identified ammonia and creatinine as leading biomarker candidates for detecting early stage CKD.

Graphic illustrating VOC buildup in kidneys and traveling to lungs and out through the breath.

TRACE-E for CKD

Trace Sensing’s CKD pilot study is in the final review stages with a leading U.S.-based academic research partner. This pilot will build upon Trace Sensing’s foundational biomarker library to validate ammonia and creatinine as predictive biomarkers of CKD and assess biologically relevant concentrations to support disease staging and progression monitoring. Study enrollment slated to begin late 2025/early 2026.