Cure8 regulatory brief
A simple home test for urinary oxalate and Ox/Crea ratio could make monitoring more practical than 24-hour urine collections, helping prevent stone recurrence and allowing earlier treatment adjustments for people at risk.
Patients at risk of calcium oxalate stones (including some IBD patients), nephrologists, gastroenterologists, and diagnostics researchers
The project is a funded research effort to finalize detection chemistry, complete a mobile app, validate membrane formulations analytically, and compare Oxalate Now results to a Roche spectrophotometric assay using biobanked urine samples.
The goal is a noninvasive, rapid monitoring device to address limitations of 24-hour urine collections (turnaround time, handling, noncompliance). The device is presented as a monitoring tool rather than a treatment. The entry lists planned validation and concordance testing; it does not report clinical results or regulatory approval yet.
This is a funded NIH project describing development and analytical validation plans; it does not present clinical trial results or regulatory clearance. The entry focuses on device development and concordance testing against a lab assay.
Review the original publication for the complete reporting, methods, and context.
Funding disclosed by the source: National Institute of Diabetes and Digestive and Kidney Diseases - R43DK146426 - $311,172
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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