List of Qualified Biomarkers
Qualified Biomarkers and Supporting Information
Requestor | Qualified Biomarker(s) | Abbreviated Biomarker Description | Abbreviated COU | Qualification Decision | Supporting 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: 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 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: 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: 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: 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/rDNA | Plasmodium 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 Executive Summary |
Additional Biomarker Information
- CDER & CBER’s DDT Qualification Project Search database
- Biomarker Qualification Submissions
- Resources for Requestors
- Biomarker Qualification Program Submission FAQs
- Guidance and Process
- More About Biomarkers and Qualification
- 21st Century Cures Act: Qualification of Drug Development Tools
Drug Development Tool Qualification Process: Transparency Provisions CDER Biomarker Qualification Program
Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov