Drugs

List of Qualified Biomarkers

Qualified Biomarkers and Supporting Information

RequestorQualified Biomarker(s)Abbreviated Biomarker DescriptionAbbreviated COUQualification DecisionSupporting Documents
Predictive Safety and Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)
 
Albumin, β2- Microglobulin, Clusterin, Cystatin C, KIM-1, Total Protein, and Trefoil factor-3
 
Urinary nephrotoxicity biomarkers as assessed by immunoassays
 
Safety biomarker to be used with traditional indicators to indicate renal injury in rat
 
Qualified
4/14/2008
 
4/14/2008: FDA Letter
1/16/2009: FDA Review
 
International Life Sciences Institute (ILSI)/ Health and Environmental Sciences Institute (HESI), Nephrotoxicity Working Group
 
Clusterin, Renal Papillary Antigen (RPA-1)
 
Urinary nephrotoxicity biomarkers as assessed by immunoassays
 
Safety biomarker to be used with traditional indicators to indicate renal injury in rat
 
Qualified
9/22/2010
 
Not Qualified: Alpha-s-glutathione transferase
 
9/22/2010: FDA Letter
9/13/2010: FDA Review
 
PJ O'Brien, WJ Reagan, MJ York and MC Jacobsen
 
Cardiac troponins T (cTnT) and I (cTnI)
 
Serum/plasma cardiotoxicity biomarkers as assessed by immunoassay
 
Safety biomarker to indicate cardiotoxicity in rats, dogs or monkeys when testing known cardiotoxic drugs and may be used to help estimate non-toxic human dose
 
Qualified
2/23/2012
 
2/23/2012: FDA Letter
1/24/2011: FDA Review
 
Mycoses Study Group
 
Galactomannan
 
Serum/broncho-alveolar lavage fluid biomarker: as assessed by immunoassay
 
Diagnostic biomarker used with other clinical and host factors to identify patients with Invasive Aspergillosis
 
Qualified
11/14/2015
 
11/14/2015:FDA Guidance
Various Dates: FDA Reviews
 
Chronic Obstructive Pulmonary Disease (COPD) Biomarker Qualification Consortium (CBQC)
 
Fibrinogen
 
Plasma biomarker as assessed by immunoassay
 
Prognostic biomarker used with other characteristics to enrich for COPD exacerbations
 
Qualified
9/14/2016
 
9/14/2016: FDA Guidance
Various Dates: FDA Reviews
 
Polycystic Kidney Disease Outcomes Consortium
 
Total Kidney Volume (TKV)
 
TKV as assessed by MRI, CT and US
 
Prognostic biomarker with patient age and baseline glomerular filtration rate for Autosomal Dominant Polycystic Kidney Disease
   
 
Qualified
9/15/2016
 
 
9/15/2016: FDA Guidance
Various Dates: FDA Reviews
Critical Path Institute's Predictive Safety Testing Consortium Nephrotoxicity Working Group (CPATH PSTC-NWG), and Foundation for the National Institutes of Health’s Biomarker Consortium Kidney Safety Biomarker Project Team (FNIH BC-KSP)
 
clusterin (CLU), Cystatin-C (CysC), Kidney Injury Molecule-1 (KIM-1), N-acetyl-beta-D-glucosaminidase (NAG), Neutrophil Gelatinase-Associated Lipocalin (NGAL), and osteopontin (OPN)
 
Urinary nephrotoxicity biomarker panel as assessed by immunoassays
 
Safety biomarker panel to aid in the detection of kidney tubular injury in phase 1 trials in healthy volunteers
 
7/25/2018
 
8/15/2018: FDA Letter
Various Dates: FDA Reviews
University of Washington Department of Laboratory Medicine  Plasmodium 18S rRNA/rDNAPlasmodium falciparum 18S rRNA/rDNA (copies/ml) measured in blood samples by a
nucleic acid amplification test
Monitoring biomarker informs initiation of treatment with anti-malarial drug following controlled human malaria infection (CHMI) with P. falciparum sporozoites in healthy subjects in clinical studies for vaccine and/or drug development. Qualified,
October 12, 2018
10/12/2018: FDA Letter Various Dates:
FDA Reviews

 

 

Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov

Page Last Updated: 12/07/2018
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