A point of care device for patients with oxalurias, the oxalate now

The National Institute of Diabetes and Digestive and Kidney Diseases awarded Analytical Diagnostic Solutions Inc. $311,172 on August 15, 2026, to develop a point-of-care device for monitoring urinary oxalate levels in patients with oxalurias and kidney stone disease under the Diabetes, Digestive, and Kidney Diseases Extramural Research program (CFDA 93.847).

Calcium oxalate stones account for 75–80% of all kidney stones, with hyperoxaluria—excess urinary oxalate excretion—as the primary risk factor for stone formation and recurrence. Current treatment relies on pharmacological interventions including thiazide diuretics and potassium citrate, but success depends on precise monitoring of urinary pH, creatinine, and oxalate levels. The standard 24-hour urine collection method is impractical for routine use due to long turnaround times, cumbersome sample handling, and noncompliance rates exceeding 30%, leaving management reactive rather than preventive.

The device addresses this gap by enabling real-time urine monitoring, replacing the current standard with an accessible, point-of-care solution for patients to track relevant biomarkers and share data with healthcare providers. Performance of work occurs in Mt Laurel Township, New Jersey. The award covers the period from August 15, 2026, through July 31, 2027. Analytical Diagnostic Solutions specializes in developing point-of-care diagnostic technologies for rare genetic and metabolic disorders; prior NIH-funded projects include diagnostic platforms for homocysteine, phenylketonuria, creatine phosphokinase, and adenosine deaminase 2 deficiency monitoring.

Abstract

Kidney stone disease (NEPHROLITHIASIS) is a growing public health concern, with a lifetime prevalence of 10- 15% in developed countries. In the united states, the incidence has increased by nearly 70% over the past three decades, now affecting 10.6% of men and 7.1% of women. This rise is linked to dietary changes, climate factors, metabolic disorders, and obesity rates. Calcium oxalate stones account for 75-80% of all kidney stones, with hyperoxaluria-excess urinary oxalate excretion-being the primary risk factor for stone formation and recurrence. The five-year recurrence rate exceeds 50%, leading to severe pain, frequent emergency room visits, and progressive kidney damage. Management of calcium oxalate kidney stones often requires pharmacological interventions aimed at reducing stone formation and recurrence. Common treatment strategies include thiazide diuretics, which lower urinary calcium excretion, and citrate supplements, which bind urinary calcium to prevent calcium oxalate crystal formation. Potassium citrate is frequently prescribed to alkalinize urine and enhance citrate excretion, further inhibiting stone formation. However, the success of these treatments depends on precise monitoring of urinary PH, creatinine, oxalate levels, and OX/crea ratios must be carefully managed to optimize therapy and minimize side effects. The economic burden of kidney stones exceeded $2.1 billion, with total economic losses surpassing $5 billion, including lost productivity and disability. Despite the growing medical and economic burden of kidney stone disease, management remains reactive rather than preventive, due primarily to the lack of accessible, real-time urine monitoring solutions. The current standard, 24-hour urine collection, is impractical for routine use because of long turnaround times, cumbersome sample handling, and noncompliance rates exceeding 30%. These limitations delay diagnosis and intervention, increasing stone recurrence risk. The oxalate now home monitoring test introduces a real-time, non-invasive solution for monitoring OX concentration, crea concentration, OX/crea ratio and urinary PH, addressing these limitations. By providing real-time feedback, IT allows patients and clinicians to intervene before oxalate levels reach dangerous thresholds. Ivds proposes oxalate now will transform patient management by reducing delays, improving diagnostic accuracy, and enhancing patient adherence to treatment regimens. The specific aims of this proposal are: finalize detection formulations, 2) complete the oxalate now mobile device APP, 3) analytical validation of membrane formulations, 4) establish concordance of oxalate now to the roche spectrophotometric assay using urine biobanked patient samples.