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  1. Biomarker Qualification Program

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

DDTBMQ000006

Menarini Silicon Biosystems Inc. / Memorial Sloan Kettering Cancer Center (MSKCC)

Contact: John Clay

 

Circulating tumor cell (CTC) numbers as assessed by immunoassay

Response biomarker used as a surrogate endpoint for survival time in castration resistant prostate cancer (mCRPC) clinical trials

 

 

507 Update
05/06/2020

507 Update Response
08/12/2020

DDTBMQ000008

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

Contact: Syril Pettit

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

 

 

 

 

 

DDTBMQ000010

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: Dr. 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)

 

LOI Withdrawn 

DDTBMQ000011

Biomarkers Consortium, Foundation for the National Institutes of Health (FNIH) & The Radiologic Society of North

 America, Quantitative Imaging Biomarkers Alliance (RSNA‐QIBA)

Contact: Dr. Ying Tang

 

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

 

DDTBMQ000036

Transbioline Workgroup

Contact: Lidia Mostovy

Serum biomarkers of liver Injury as assessed by multiple assays

Safety biomarkers to detect drug-induced hepatic injury

 

Legacy project in transition to 507 process 

 

DDTBMQ000038

Foundation for the National Institutes of Health Biomarkers Consortium

Contact: J. Menetski, PhD

 

Anatomic features of bone as assessed by MRI

Prognostic biomarkers to identify patients more likely to experience knee osteoarthritis disease progression

507 Update
1/21/2019

507 Update Response
05/06/2019

DDTBMQ000039

AnaBios Corporation

Contact: Dr. Jack A. Reynolds

 

Torsades de pointes proarrhythmia features

 

Safety biomarker score to assess pre-clinical risk identification of drug-induced pro-arrhythmia (torsades de pointes)

 

 

 

507 Update
04/16/2019

 

507 Update Response
05/06/2019

DDTBMQ000046

Fossa Consulting

Contact: Andreas Benesic

 

Beat to beat restitution as assessed by ECG

Safety biomarker for pro-arrhythmia risk assessment

 

LOI withdrawn

DDTBMQ000049

Drs. Benesic and Gerbes

Contact: Andreas Benesic

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

 

Safety biomarker for pro-arrhythmia risk

 

LOI Withdrawn

DDTBMQ000050

C-PATH PSTC Hepatotoxicity Working Group (HWG) or Critical Path Institute (CPATH) Predictive Safety Testing Consortium (PSTC) or Critical Path Institute (CPATH)Predictive Safety

Contact: John Michael Sauer, Ph.D.

Glutamate Dehydrogenase (GLDH)

Safety biomarker to assess drug-induced liver injury

 

507 Update
06/29/2018

 

 

QP
11/14/2019

 

507 Update Response
10/25/2018

 

QP-Accepted
05/13/2020

DDTBMQ000051

Perspectum Diagnostics Ltd.

Contact: Ioan Wigley

 

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
01/19/2019

 

 

 

DDTBMQ000053

Magnetic Resonance Enterography (MRE) Consortium
 

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

 

DDTBMQ000054

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 used to assess the clinical endpoints of hip and non-vertebral fracture risk reduction 

507 Update
8/25/2018

507 Update Response
10/16/2018

DDTBMQ000057

COPD Foundation

Contact: Debora Merrill

 

Blood Eosinophil count as assessed by blood analyzer

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

 

  1. Predictive biomarker for subjects who are more likely to respond to anti-inflammatory treatments

1. LOI 8/29/2016

 

 

2. LOI 04/05/2019

 

 

 

1. LOI - Not Accepted
12/18/2017

 

2. LOI - Not Accepted 8/12/2019

 

DDTBMQ000070

CPATH TB Drug Regimens (CPTR)

Contact: Klaus Romero

 

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

 

DDTBMQ000071

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
3/14/2018

 

DDTBMQ000074

FLUIDDA, Inc.

Contact: Jan De Backer

 

CT or 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

 

DDTBMQ000075

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
4/25/2018

 

LOI - Accepted
9/6/2018

 

DDTBMQ000076

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 subject’s opioid use disorder to enrich buprenorphine trials.

LOI
6/11/2018

 

LOI - Not Accepted
9/5/2018

 

DDTBMQ000077

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

DDTBMQ000078

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

 

DDTBMQ000079

Nerve Unit Massachusetts General Hospital

Contact: Dr. Ann 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
11/08/2018

 

DDTBMQ000081

Critical Path Institute (CPATH)Predictive Safety Testing Consortium and Duchenne Regulatory Science

Contact: John-Michael Sauer

 

 

 

Skeletal Muscle Injury Biomarker Panel as assessed by immunoassay

 

 

Safety biomarker panel biomarker to aid in the detection of acute drug induced skeletal muscle injury in phase 1 trials

 

 

LOI
12/17/2019

LOI-Accepted
5/13/2020

 

 

DDTBMQ000082

Perspectum Diagnostics

Contact: Jaco Jacobs, PhD

 

 

MRI Measured Proton Density Fat Fraction (MRI-PDFF) of Liver

 

Diagnostic enrichment biomarker for selecting patients for non-alcoholic steatohepatitis (NASH) trials

LOI
12/2/2018

LOI - Accepted
4/12/2019

DDTBMQ000083

FNIH Biomarkers Consortium Autism Biomarkers Consortium for Clinical Trials (ABC-CT)

Contact James McPartland, PhD

 

N170 to Upright Faces

 

Diagnostic biomarker to enrich clinical trials by reduction of ASD-associated heterogeneity.

LOI
1/31/2019

 

LOI - Accepted
5/6/2019

DDTBMQ000084

Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium – NIMBLE

Contact: Dr. Tania Kamphaus

 

Four circulating biomarker panels for NASH

Diagnostic biomarker to enrich and to identify patients likely to have liver histopathologic findings of nonalcoholic steatohepatitis (NASH)

LOI
10/29/2019

LOI-Accepted
2/4/2020

DDTBMQ000086

Tufts Medical Center

Contact: T. McAlindon, MD, MPH

 

End Stage Knee Osteoarthritis (esKOA) Score

Prognostic biomarker to identify patients likely to experience long-term disease progression.

LOI
9/5/2019

LOI-Accepted
12/20/2019

 

Tufts Medical Center

DDTBMQ000087

Contact: T. McAlindon, MD, MPH

 

Cumulative Damage and Disease Activity Scores

Prognostic enrichment biomarker to identify patients likely to experience long-term disease progression

LOI
9/5/2019

LOI-Accepted
12/20/2019

 

DDTBMQ000089

Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium

Contact: Stephanie Cush

 

Anatomic bone features

Prognostic enrichment imaging biomarker to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression

LOI
9/19/2019

 

LOI-Accepted
1/21/2020

 

DDTBMQ000090

Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium

Contact: Stephanie Cush

 

 

Osteoarthritis prognostic biomarkers as assessed by immunoassays

Prognostic enrichment biomarker panel to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression

LOI
9/18/2019

 

LOI-Accepted
2/25/2020

DDTBMQ000093

Foundation for the National Institutes of Health Autism Biomarkers Consortium for Clinical Trials (FNIH ABC-CT)

Contact: James McPartland, Ph.D.

 

Oculomotor Index of Gaze to Human Faces

Diagnostic to select a less heterogeneous subgroup within subjects with autism spectrum disorder (ASD) for clinical trial enrichment.

LOI
1/30/2020

 

LOI-Accepted
3/17/2020

 

 

DDTBMQ000094

TransBioLine

Contact: Lidia Mostovy

 

Drug-induced vascular injury (DIVI) biomarkers measured in the blood by immunoassays and mass spectrometry

Monitoring biomarker for DIVIto measure inflammation, vascular endothelial and smooth muscle damage.

507 Update
01/24/2019

 

LOI
11/12/2019

 

507 Update Response 04/12/2019

 

LOI-Accepted
2/4/2020

DDTBMQ000095

LITMUS

Contact: Elisabeth Erhardtsen

 

Composite biomarker consisting of PRO-C3 and FAST Score

Diagnostic enrichment biomarker to identify patients likely to have liver histopathologic findings of nonalcoholic steatohepatitis (NASH)

LOI
12/18/2019

 

LOI-Accepted
5/7/2020

 

 

DDTBMQ000097

Critical Path Institute (C-Path), Transplant Therapeutics Consortium (TTC)

Contact: Inish O’Doherty, PhD

 

Composite biomarker panel to predict five-year risk of kidney allograft loss

Reasonably likely surrogate endpoint for use in clinical trials to support evaluation of immunosuppressive therapy applications.

LOI
2/14/2020

LOI-Accepted
6/1/2020

 

DDTBMQ000099

Resoundant, Inc.

Contact: Kay Pepin

 

Magnitude of the complex shear modulus (|G*|)

Diagnostic biomarker to pre-screen patients with clinical risk factors for chronic liver disease for enrolment in clinical trials to identify those at high risk of having histopathologic findings of significant fibrosis

LOI
5/4/2020

LOI-Accepted
8/7/2020

DDTBMQ000100

University of Washington Department of Laboratory Medicine

Contact: Dr. Sean Murphy

 

Plasmodium 18S rRNA/rDNA

Monitoring biomarker informs initiation of treatment with anti-malarial drug following controlled human malaria infection (CHMI) with P. falciparum sporozoites in healthy subjects from endemic areas

LOI
3/10/2020

LOI-Accepted
8/28/2020

 

DDTBMQ000101

Innovative Medicines Initiative (IMI) TransBioLine Drug-Induced CNS Injury (DINI) Work Package

Contact: Lidia Mostovy

 

Drug-induced serum-based CNS injury biomarker panel

Safety biomarker panel to detect acute drug-induced central nervous system (CNS) injury risk in Phase 1 trials

LOI
3/18/2020

LOI-Accepted
7/3/2020

DDTBMQ000103

Yale University

Contact: Tyrone Cannon

Individualized Risk Calculator for Psychosis (IRC-P)

Prognostic biomarker intended for use in clinical trials to enrich for individuals most likely to progress to full psychosis and poor long-term functional outcomes

LOI
4/6/2020

 

LOI-Accepted
5/28/2020

DDTBMQ000104

IGEA Research Corporation

Contact: Rosanna Squitti

 

Free copper in serum assessed by inductively coupled plasma mass spectrometry (ICPMS)

Serum Free Copper as a prognostic biomarker for conversion from mild cognitive impairment (MCI) to symptomatic Alzheimer’s disease (AD)

LOI
6/11/2020

 

LOI-Not Accepted
9/9/2020

 

DDTBMQ000105

PathAI, Inc.

Contact: Katy Wack

 

Histologic features as assessed on liver biopsy as interpreted by Artificial Intelligence (AI).

Diagnostic biomarker to assess disease activity score components (and fibrosis stage in liver biopsies as part of evaluation for enrollment in non-alcoholic steatohepatitis (NASH) clinical trials.

LOI
6/8/2020

LOI-Accepted
9/18/2020

 

DDTBMQ000106

LITMUS

Contact: Elisabeth Erhardtsen

 

corrected T1 (cT1) as assessed by MRI and serum biomarkers as assessed by Enhanced Liver Fibrosis (ELF) test

Prognostic enrichment biomarker to identify NASH patients more likely to experience clinical endpoints such as progression to cirrhosis, hepatic decompensation events during the timeframe of a NASH clinical trial

LOI
9/3/2020

LOI-Accepted
12/3/2020

DDTBMQ000107

University of Washington Department of Laboratory Medicine

Contact: Dr. Sean Murphy

 

Plasmodium 18S rRNA/rDNA

 

 

Biomarker endpoint to be used in clinical trials to evaluate drugs and/or vaccines intended to treat or prevent Plasmodium falciparum in endemic areas.

 

 

LOI
5/18/2020

LOI-Accepted
8/28/2020

DDTBMQ000108

Innovative Medicines Initiative TransBioLine - Drug-Induced Kidney Injury Work Package

Contact: Lidia M. Mostovy

 

Urine and serum biomarker of drug induced kidney injury as assessed by multiple assays

Safety biomarker panel to detect acute drug-induced kidney injury risk in Phase 1 trials

LOI
5/15/2020

LOI-Accepted
8/20/2020

DDTBMQ000110

Innovative Medicines Initiative TransBioLine Drug-induced Pancreas Injury Work Package

Contact: Lidia D. Mostovy

Drug-induced acute pancreatitis biomarker panel

Safety biomarker panel to detect acute drug-induced pancreatitis in Phase 1 trials

LOI
08/31/2020

LOI–Not Accepted
01/04/202

 

Additional Biomarker Information

 

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

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