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  1. Drug Development Tool Qualification Programs

Biomarker Qualification Submissions

Biomarker Qualification Submissions

The table below lists information about submissions to the FDA biomarker qualification program for which final biomarker qualification decisions have not yet been made. This table includes legacy projects (those submitted prior to passage of the 21st Century Cures Act, Section 3011 legislation [Food, Drug and Cosmetic Act (FD&CA), new section 507 process or “section 507 process”]) as well as those submitted as part of the 507 process. This table is updated on a biannual basis and provides information on the biomarker qualification project, FDA’s decision to Accept or Not Accept the submission, and FDA’s recommendations on further biomarker development.

*Information submitted to FDA by outside parties requesting qualification of a drug development tool is not endorsed or recommended by FDA. Submissions are made publicly available in accordance with the 21st Century Cures Act. The FDA makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the information in submissions. See the FDA decision letter corresponding to each submission for FDA considerations and recommendations related to each request for qualification.

For more information about the Biomarker Qualification Program, you may contact:
CDER-BiomarkerQualificationProgram@fda.hhs.gov.

Biomarker Qualification (BQ) Submissions

Requestor Abbreviated Biomarker Description Abbreviated COU * Qualification Submission & Reviewable Date FDA Submission Decision & Recommendations

Memorial Sloan-Kettering Cancer Center/Medivation, Inc./Janssen Diagnostics, LLC

Contact: Debra Rasmussen

Circulating tumor cell (CTC) alone or in combination with lactate dehydrogenase (LDH) as assessed by cell-based assay

Pharmacodynamic/response biomarker used as a surrogate endpoint for survival time in studies of metastatic castration resistant prostate cancer (mCRPC)

Legacy project in transition to 507 process 

 

Critical Path Institute (C-Path),
Predictive Safety Testing Consortium, (PSTC),
Skeletal Muscle Working Group (SKM WG)

Contact: John-Michael Sauer

Skeletal muscle injury (SKM1-8) biomarkers as assessed by immunoassay

Safety biomarkers to monitor skeletal muscle degeneration in rats with serum creatinine kinase and serum aspartate aminotransferase (AST)

 Legacy project in transition to 507 process 

 

International Life Sciences Institute (ILSI) /Health and Environmental Sciences Institute (HESI)

Contact:  Raegan O'Lone

Transcriptomic biomarker panel as assessed by RT-qPCR and microarray

Safety biomarker to identify in-vitro mammalian cell structural chromosomal damage

 Legacy project in transition to 507 process

 

Joint Qualification Committee of the Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium (BC) and the Radiologic Society of North America (RSNA) Quantitative Imaging Biomarker Alliance (QIBA)

Contact: Linda Doody

Standardized uptake value (SUV) of tumors as measured by quantitative FDG-PET/CT

Pharmacodynamic/response biomarker to accelerate evaluations of novel treatment of NSCLC (lung cancer) and DLBCL (lymphoma)

 Legacy project in transition to 507 process 

 

FNIH/BC- RSNA/QIBA
Contact: Linda Doody

Tumor Volume as measured by CT

Pharmacodynamic/response biomarker used to predict disease progression or tumor response in primary and metastatic cancers

 Legacy project in transition to 507 process 

 

C-Path PSTC Nephrotoxicity Working Group (NWG)

Contact: John-Michael Sauer

Urinary biomarkers of kidney injury as assessed by immunoassay

Safety biomarkers to complement the detection of acute drug-induced renal tubule injury in rat

 Legacy project in transition to 507 process 

 

C-Path/CAMD

Contact: Diane Stephenson

Hippocampal volume as measured by MRI

Prognostic biomarker to enrich studies of amnestic mild cognitive impairment patients who are likely to develop progressive Alzheimer's disease

 Legacy project in transition to 507 process 

 

FLUIDDA, Inc.

Contact: Jan De Backer

Lung and airway structural and functional parameters as assessed by CT

Pharmacodynamic/response biomarker to assess response to an intervention in COPD and asthma patients

Legacy project in transition to 507 process 

 

Safer And Faster Evidence-based Translation (SAFE-T) Consortium

Contact: Nicolas Creff

Urine and serum biomarkers of drug-induced kidney injury as assessed by assay

Safety biomarkers to detect drug-induced kidney injury

 Legacy project in transition to 507 process 

 

SAFE-T Consortium

Contact: Nicolas Creff

Serum biomarkers of drug-induced liver Injury as assessed by multiple assays

Safety biomarkers to detect drug-induced hepatic injury

 Legacy project in transition to 507 process 

 

SAFE-T Consortium

Contact: Nicolas Creff

Serum biomarkers of drug-induced vascular injury as assessed by multiple assays

Safety biomarkers to detect a risk of vascular injury

 Legacy project in transition to 507 process 

 

 

FNIH Biomarker Consortium

Contact:  David Hunter

Cartilage thickness as assessed by MRI

Pharmacodynamic/response biomarker for assessing treatments for knee osteoarthritis

 Legacy project in transition to 507 process 

 

AnaBios Corporation

Contact: Jack Reynolds

Algorithm-derived biomarker as assessed by myocardial cell assay

Safety biomarker to rank pro-arrhythmic drugs based on likelihood of arrhythmia

 Legacy project in transition to 507 process 

 

Fossa Consulting

Contact: Anthony Fossa

Beat to beat restitution as assessed by ECG

Safety biomarker for arrhythmia risk

Legacy project in transition to 507 process 

 

Drs. Benesic and Gerbes

Contact: Andreas Benesic

Proteomic biomarker panel as assessed from blood monocytes using a cell-based assay

Safety biomarker to assess idiopathic drug-induced liver injury

 Legacy project in transition to 507 process 

 

C-PATH PSTC Hepatotoxicity Working Group (HWG)

 

Contact: Elizabeth Walker

Serum Glutamate Dehydrogenase (GLDH) as assessed by immunoassay

Safety biomarker to detect drug-induced liver injury

Legacy project in transition to 507 process 

 

Perspectum Diagnostics

Contact:  Jaco Jacobs

Iron corrected liver inflammation and fibrosis (LIF) biomarkers as assessed by MRI

Prognostic biomarker to identify patients who are more likely to have liver histopathology for nonalcoholic steatohepatitis (NASH)

 Legacy project in transition to 507 process 

 

C-PATH MREC

Contact: John-Michael Sauer

Anatomic features of the terminal ileum and large bowel assessed by MRI

Pharmacodynamic/response biomarker for Crohn’s disease used as a co-primary endpoint

LOI - 5/26/2017 

LOI - Accepted
7/31/2017 

COPD Foundation

Contact: Debora Merrill

Blood Eosinophil count as assessed by blood analyzer

Predictive biomarker for subjects who are more likely to exhibit COPD exacerbations

LOI - 8/29/2016

LOI - Not Accepted
12/18/2017

CPATH
TB Drug Regimens (CPTR)

Contact: Martha Brumfield

Lipoarabinomannan as assessed by immunoassay

Pharmacodynamic response biomarker to assess treatment response in patients with pulmonary tuberculosis

LOI - 6/23/2017

LOI - Accepted
10/31/2017

CPATH
Type1 Diabetes Consortium

Contact: Inish O’Doherty

Islet cell autoantibodies as assessed by immunoassay

Susceptibility/risk biomarker to identify individuals more likely to develop type 1 diabetes

LOI - 8/31/2017

LOI - Accepted
3/25/2018

Center for Studies of Addiction: University of Pennsylvania Perelman School of Medicine

Contact: H. Kranzler, M.D.

rs678849, a SNP in ORPD1, as identified by genotyping assay Predictive biomarker for certain subjects opioid use disorder to enrich buprenorphine trials. LOI - 6/11/2018

LOI Not Accepted
9/5/2018

CPATH 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)

Contact: John-Michael Sauer

Urinary nephrotoxicity biomarkers as assessed by immunoassays

Safety biomarker panel to assess whether a drug has caused mild injury response in the renal tubules in normal healthy volunteers and patients with normal renal function

LOI -04/25/2018

LOI -
Accepted -
09/06/2018

The Progeria Research Foundation

Contact: Leslie Gordon, M.D., Ph.D.

Progerin, an abnormal splice variant of the inner nuclear membrane protein lamin A Pharmacodynamic/response biomarker to assess drug intervention in future clinical treatment trials of Progeria LOI - 6/27/2018 LOI - Accepted
9/5/2018

Critical Path Institute (CPATH)
Predictive Safety Testing
Consortium (PSTC)

Contact: John-Michael Sauer, Ph.D.

Glutamate Dehydrogenase (GLDH) Safety biomarker for drug induced liver injury in healthy subjects and patients in all stages of drug development trials 507 Update - 6/29/2018 507 Update Response
10/25/2018

Foundation for the National Institutes of Health (FNIH)

Contact: Tania Nayak Kamphaus

Proportional change in dual-energy x-ray absorptiometry (DXA) bone mineral density (BMD) Surrogate endpoint for the clinical endpoints of hip and non-vertebral fracture risk reduction  507 Update - 8/25/2018

507 Update Response,
10/26/2018

Nerve Unit Massachusetts General Hospital

Contact: Ann L. Oaklander

Epidermal Neurite Density as manually counted at the dermal-epidermal junction

Diagnostic biomarker, used with other clinical indicators, to confirm a diagnosis of SFPN in drug development studies

 

LOI 8/1/2018  

LOI Accepted
11/11//2018

 

Rady Faculty of Health Sciences
University of Manitoba
Contact: Peter L. Nickerson
​HLA DR/DQ Eplet Mismatch Score manually counted from software mismatch identification Prognostic biomarker, used with other testing, to categorize kidney transplant recipients’ risk of graft rejection for enrichment or stratification in drug development studies LOI 8/13/2018 LOI Accepted
12/04//2018
Perspectum Diagnostics
Ltd
Contact: Dr. Jaco Jacobs
​Iron Corrected T1 (cT1) MR image of liver tissue Diagnostic enrichment biomarker used in conjunction with clinical risk factors to identify patients more likely to have liver histopathologic findings of Nonalcoholic steatohepatitis (NASH) 507 Update,
10/16/2018
507 Update
response, 1/19/2019

Biomarkers Consortium, Foundation for the National Institutes of Health (FNIH) & The Radiologic Society of North America, Quantitative Imaging Biomarkers Alliance (RSNA‐QIBA)

Contact: Dr. Linda Doody, PhD

​Tumor volume change as measured by CT Pharmacodynamic/Response biomarker to assess tumor volume change for new oncologic drug clinical trial therapy of solid tumors 507 Update,
11/02/2018
507 Update Response,
2/19/2019

FLUIDDA, Inc.

Contact: Jan De Backer

Volume of lower lung lobes (VLLL) as measured by CT Monitoring biomarker, used with other parameters, for correlation with changes in IPF status in drug development studies LOI -
8/13/2018
LOI - Not Accepted
1/29/2019

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Additional Biomarker Information

 

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