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# Guidance on Total Kidney Volume Biomarker
- URL: https://www.fdaweb.com/guidance-on-total-kidney-volume-biomarker/
- Published: 2016-09-15T12:00:00.000Z
- Updated: 2026-09-14T21:32:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136821

FDA has released a [guidance ](http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM458483.pdf?ref=fdaweb.com)on “Qualification of Biomarker Total Kidney Volume (TKV) in Studies for Treatment of Autosomal Dominant Polycystic Kidney Disease” that provides a qualified context of use (COU) for the biomarker TKV in such studies. The document also describes the experimental conditions and constraints for which this biomarker is qualified through CDER’s Biomarker Qualification Program. The biomarker can be used by drug developers for the qualified COU in INDs, NDAs and BLAs without a CDER review group reconsidering and reconfirming its suitability, the agency says.