List of Qualified Biomarkers
Announcement: Effective May 1, 2024, the Qualified Biomarkers and Supporting Information table currently on this page will be removed. The table will be replaced with instructions on how to query the CDER & CBER DDT Qualification Project Search database where users can access the most up-to-date information about qualified biomarkers and biomarker qualification submissions currently under development. For more information, contact CDER-BiomarkerQualificationProgram@fda.hhs.gov.
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