U Col IV
Urinary collagen type 4 express test
Chronic kidney disease (CKD) affects 14% of the US population – that is 1 in 7 people. Nearly half of the adults (47%) in the US have hypertension, which is the leading cause and main risk factor for kidney disease. CKD progresses in 5 stages and is often undetected until symptoms arise during stage 4. Stage 5, also known as ESRD (end-stage renal disease) is total and permanent loss of kidney function and requires dialysis or a kidney transplant for survival. Urinary collagen 4 (U Col IV) is the earliest marker for kidney disease.
This project will focus on developing a paper-based “point of care” (POC) test for U Col IV.
This test will be developed as a paper-based microfluidic device; this ensures low manufacturing costs and resistance to environmental factors, making it accessible to a larger population.
Summary
Chronic Kidney Disease (CKD) ranks as the 9th leading cause of death in the USA and often remains undetected until it reaches an advanced stage. CKD affects both high-risk and healthy populations. Preventing and detecting CKD early significantly enhances patients' quality of life and longevity. Early-stage treatment involves simple dietary and lifestyle changes, but as CKD advances, due to the irreversible nature of the illness, more serious interventions become necessary. The cost of managing CKD is substantial, with Medicare spending for ESRD patients reaching $52.3 billion in 2022.
The device we are developing uses urinary collagen IV as an early biomarker to quantify the level of kidney damage. It offers a cost-effective test for less than $10, requiring no additional equipment or specialized training to administer. Results are available within 20 minutes after sample introduction.
The current problem
Chronic Kidney Disease (CKD) ranks as the 9th leading cause of death in the USA and often remains undetected until it reaches an advanced stage, such as CKD stage 4. The kidneys are known as "silent sufferers" because they typically do not cause pain or show symptoms until late stage IIIB. Unlike diseases affecting organs like the pancreas, liver, or stomach, CKD lacks early warning signs, making it difficult to detect. Once kidney damage occurs, it cannot be reversed, only slowed, as the existing damage to the kidney only accelerates the decline in kidney function.
CKD affects both high-risk and healthy populations. The two most significant risk factors, high blood pressure (49.7%) and diabetes (11.6%). Both are prevalent in the US, with 1 in 5 and 1 in 3 individuals, respectively. Additional strain on kidneys can result from excessive supplement intake or inadequate hydration making even the health conscious groups susceptible to this disease. Early detection and prevention are crucial, yet current diagnostic methods, such as the estimated glomerular filtration rate (eGFR) and urinary albumin to creatinine ratio (uACR), often identify CKD only when symptoms appear. Doctors often do not these tests without visible symptoms due to cost and inconvenience for the patient and the doctor.
Preventing and detecting CKD early significantly enhances patients' quality of life and longevity. Early-stage treatment involves simple dietary and lifestyle changes, but as CKD advances to stage IIIA, treatment options become more restrictive, involving medications and significant lifestyle adjustments. By stage V, or end-stage renal disease (ESRD), patients require dialysis or a kidney transplant to survive. The cost of managing CKD is substantial, with Medicare spending reaching for just ESRD patients $52.3 billion in 2022. ESRD patients face annual expenses of $67,993, underscoring the financial burden of this disease.
Our Solution
Utah Research Institute (URI) is developing an alternative testing solution utilizing Urinary Collagen IV (U Col IV) as an early biomarker for chronic kidney disease (CKD), detectable as early as stage I. This device requires just a few drops of urine and employs innovative programmable capillary microvalves to automatically deliver reagents onto a paper array, providing a visual indication of CKD progression. The test, which costs $2.00 to manufacture and takes only 20 minutes from sample intake to result output, enables patients and clinicians to detect CKD early without incurring laboratory fees. Additionally, patients can perform the test at home to monitor the progression of their disease and seek medical attention if necessary.
Our affordable U Col IV detection passive immunoassay provides a powerful tool for fast, easy semi-quantification of CKD status without requiring instrumentation or electronics. It will also expand to detect biomarkers for other diseases, improving CKD patients' quality of life and extending their lifespan. By preventing progression to ESRD, this solution not only enhances patient outcomes but also reduces the substantial financial burden associated with CKD management.
R&D timeline
October 2024
Preliminary clinical study: Correlation of Urinary Collagen IV with stage of Chronic Kidney Disease
November 2024
Characterization of paper test with Urinary Collagen IV to correlate with stage of Chronic Kidney Disease
April 2025
Fabrication and characterization of structurally programmable microvalves
June 2025
Integration of in-device reagent storage reservoirs, and structural programmable microvalves
November 2025
Transfer of device into a permanent market ready housing, in field trials with patients refining design further
