Biomarker Qualification Submissions
Announcement: After May 1, 2024, this page will be archived. Users will be redirected to a new page with instructions on how to query the CDER & CBER DDT Qualification Project Search database to access information about qualified biomarkers and biomarker qualification submissions currently under development. For more information, contact CDER-BiomarkerQualificationProgram@fda.hhs.gov.
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
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Requestor |
Abbreviated Biomarker Description |
Abbreviated COU |
*Qualification Submission & Reviewable Date |
FDA Submission Decision & Recommendations |
|---|---|---|---|---|
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DDTBMQ000006 Menarini Silicon Biosystems Inc. / Memorial Sloan Kettering Cancer Center (MSKCC)
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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
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DDTBMQ000008 International Life Sciences Institute (ILSI) /Health and Environmental Sciences Institute (HESI) |
Transcriptomic biomarker panel as assessed by RT-qPCR and microarray |
Safety biomarker to identify in-vitro mammalian cell structural chromosomal damage |
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Legacy project in transition to 507 process
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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)
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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) |
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LOI Withdrawn |
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DDTBMQ000011 Biomarkers Consortium, Foundation for the National Institutes of Health (FNIH) & The Radiologic Society of North America, Quantitative Imaging Biomarkers Alliance (RSNA‐QIBA)
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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 |
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DDTBMQ000036 Transbioline Workgroup |
Serum biomarkers of liver Injury as assessed by multiple assays |
Safety biomarkers to detect drug-induced hepatic injury |
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Legacy project in transition to 507 process
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DDTBMQ000038 Foundation for the National Institutes of Health Biomarkers Consortium
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Anatomic features of bone as assessed by MRI |
Prognostic biomarkers to identify patients more likely to experience knee osteoarthritis disease progression |
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DDTBMQ000039 AnaBios Corporation
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Torsades de pointes proarrhythmia features
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Safety biomarker score to assess pre-clinical risk identification of drug-induced pro-arrhythmia (torsades de pointes)
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DDTBMQ000046 Fossa Consulting
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Beat to beat restitution as assessed by ECG |
Safety biomarker for pro-arrhythmia risk assessment |
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LOI withdrawn |
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DDTBMQ000049 Drs. Benesic and Gerbes |
Proteomic signature in monocyte-derived cells from patients with suspected acute liver injury
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Safety biomarker to differentiate DILI events from non-DILI events in patients with suspected acute liver injury |
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LOI Withdrawn |
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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 |
Glutamate Dehydrogenase (GLDH) |
Safety biomarker to assess drug-induced liver injury |
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507 Update Response
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DDTBMQ000051 Perspectum Diagnostics Ltd.
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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) |
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507 Update Response
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DDTBMQ000053 Magnetic Resonance Enterography (MRE) Consortium
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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 |
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DDTBMQ000054 Foundation for the National Institutes of Health (FNIH) |
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 |
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DDTBMQ000057 COPD Foundation
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Blood Eosinophil count as assessed by blood analyzer |
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1. LOI - Not Accepted
2. LOI - Not Accepted 8/12/2019
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DDTBMQ000070 CPATH TB Drug Regimens (CPTR)
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Lipoarabinomannan as assessed by immunoassay |
Pharmacodynamic response biomarker to assess treatment response in patients with pulmonary tuberculosis |
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DDTBMQ000071 CPATH Type1 Diabetes Consortium
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Islet cell autoantibodies as assessed by immunoassay |
Susceptibility/risk biomarker to identify individuals more likely to develop type 1 diabetes |
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DDTBMQ000074 FLUIDDA, Inc.
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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 |
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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)
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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 |
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DDTBMQ000076 Center for Studies of Addiction: University of Pennsylvania Perelman School of Medicine
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rs678849, a SNP in ORPD1, as identified by genotyping assay |
Predictive biomarker for certain subject’s opioid use disorder to enrich buprenorphine trials. |
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DDTBMQ000077 Rady Faculty of Health Sciences University of Manitoba
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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 |
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DDTBMQ000078 The Progeria Research Foundation Contact: Leslie Gordon, M.D., Ph.D.
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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 |
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DDTBMQ000079 Nerve Unit Massachusetts General Hospital
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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 |
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DDTBMQ000081 Critical Path Institute (CPATH)Predictive Safety Testing Consortium and Duchenne Regulatory Science
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Skeletal Muscle Injury Biomarker Panel as assessed by immunoassay
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Safety biomarker panel biomarker to aid in the detection of acute drug induced skeletal muscle injury in phase 1 trials
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DDTBMQ000082 Perspectum Diagnostics
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MRI Measured Proton Density Fat Fraction (MRI-PDFF) of Liver |
Diagnostic enrichment biomarker for selecting patients for non-alcoholic steatohepatitis (NASH) trials |
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DDTBMQ000083 FNIH Biomarkers Consortium Autism Biomarkers Consortium for Clinical Trials (ABC-CT) |
N170 to Upright Faces |
Diagnostic biomarker to enrich clinical trials by reduction of ASD-associated heterogeneity. |
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DDTBMQ000084 Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium – NIMBLE
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Four circulating biomarker panels for NASH |
Diagnostic biomarker to enrich and to identify patients likely to have liver histopathologic findings of nonalcoholic steatohepatitis (NASH) |
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DDTBMQ000086 Tufts Medical Center Contact: T. McAlindon, MD, MPH
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End Stage Knee Osteoarthritis (esKOA) Score |
Prognostic biomarker to identify patients likely to experience long-term disease progression. |
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Tufts Medical Center DDTBMQ000087 Contact: T. McAlindon, MD, MPH
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Cumulative Damage and Disease Activity Scores |
Prognostic enrichment biomarker to identify patients likely to experience long-term disease progression |
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DDTBMQ000089 Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium
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Anatomic bone features |
Prognostic enrichment imaging biomarker to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression |
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DDTBMQ000090 Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium
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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 |
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DDTBMQ000093 Foundation for the National Institutes of Health Autism Biomarkers Consortium for Clinical Trials (FNIH ABC-CT) Contact: James McPartland, Ph.D.
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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. |
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DDTBMQ000094 TransBioLine
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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. |
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507 Update Response 04/12/2019
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DDTBMQ000095 LITMUS
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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) |
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DDTBMQ000096 IMI-TRISTAN Consortium |
Gadoxetate signal as measured by MRI
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Safety biomarker indicating potential intrahepatic drug-drug interactions.
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LOI 2/25/2021 |
LOI Determination Letter 5/14/2021
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DDTBMQ000097 Critical Path Institute (C-Path), Transplant Therapeutics Consortium (TTC)
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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. |
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DDTBMQ000099 Resoundant, Inc.
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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 |
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DDTBMQ000100 University of Washington Department of Laboratory Medicine
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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 |
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DDTBMQ000101 Innovative Medicines Initiative (IMI) TransBioLine Drug-Induced CNS Injury (DINI) Work Package
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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 |
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DDTBMQ000103 Yale University |
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 |
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DDTBMQ000104 IGEA Research Corporation
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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) |
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DDTBMQ000105 PathAI, Inc.
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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. |
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DDTBMQ000106 LITMUS
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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 |
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DDTBMQ000107 University of Washington Department of Laboratory Medicine
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Plasmodium 18S rRNA/rDNA
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Biomarker endpoint to be used in clinical trials to evaluate drugs and/or vaccines intended to treat or prevent Plasmodium falciparum in endemic areas.
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DDTBMQ000108 Innovative Medicines Initiative TransBioLine - Drug-Induced Kidney Injury Work Package
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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 |
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DDTBMQ000109 Stemina |
Metabolite Ratio of Ornithine to Cystine |
Safety biomarker for in vitro developmental toxicity screening at the nonclinical stage of drug development for small molecule drug candidates as part of a weight-of-evidence assessment as described in the ICH S5(R3) guideline. |
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DDTBMQ000110 Innovative Medicines Initiative TransBioLine Drug-induced Pancreas Injury Work Package |
Drug-induced acute pancreatitis biomarker panel |
Safety biomarker panel to detect acute drug-induced pancreatitis in Phase 1 trials |
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DDTBMQ000112 Foundation for the National Institutes of Health Biomarkers Consortium Non-Invasive Biomarkers of MetaBolic Liver DiseasE (NIMBLE) |
Ultrasound biomarkers |
Diagnostic enrichment biomarker intended for use, in conjunction with clinical factors, to identify patients likely to have liver histopathologic findings of nonalcoholic steatohepatitis (NASH) and with a nonalcoholic fatty liver disease activity score (NAS) ≥4 and liver fibrosis stages 2 or 3 (by Brunt/Kleiner scale) |
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DDTBMQ000113 TransBioLine Contact: Lidia D. Mostovy |
Drug-induced liver injury biomarker panel |
Safety biomarker panel that aids in identifying clinical trial subjects with potential acute liver injury caused by drugs, in whom dose reduction or dose interruption is warranted. | LOI 2/16/2021 |
LOI – Accepted 5/14/2021 |
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DDTBMQ000114 University of Florida Department of Applied Physiology and Kinesiology Contact: Dr. David Vaillancourt |
Web-based Automated Imaging Differentiation of Parkinsonism | Differential diagnosis of PD, MSAp, and PSP which are forms of Parkinsonism. The use can be in clinical drug trials to diagnose patients for entry into study and/or enrich the cohort in the clinical drug trial. | LOI-Accepted 6/4/2021 |
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DDTBMQ000115 University of Maryland, Baltimore School of Pharmacy Contact: Dr. Maureen Kane |
Plasma traumatic brain injury biomarkers as assessed by liquid chromatography-tandem mass spectrometry | Diagnostic enrichment biomarker in conjunction with other clinical factors based on the plasma biomarker level to identify patients with traumatic brain injury by blunt mechanism head injury appropriate for inclusion in drug development clinical trials | LOI-Not Accepted 7/27/2021 |
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DDTBMQ000117 Histoindex Contact: Anthony Lie |
Second Harmonic Generation (SHG) and Machine-Learning based Model for a Stain free and Fully Quantitative Measurement of Fibrosis (qFibrosis) in Non-Alcoholic Steatohepatitis (NASH) Clinical Trials | Diagnostic biomarker that is stain-free and AI-based, to evaluate treatment response based on fibrosis change in liver biopsies from baseline to end-of-treatment (EOT) in patients enrolled in clinical trials for treatment of non-alcoholic steatohepatitis (NASH). | LOI–Not Accepted 12/19/2022 |
Additional Biomarker Information
- CDER & CBER’s DDT Qualification Project Search database
- List of Qualified Biomarkers
- Resources for Biomarker Requestors
- Biomarker Qualification Program Submission FAQs
- Guidance and Process
- More About Biomarkers and Qualification
- 21st Century Cures Act: Qualification of Drug Development Tools
- Biomarker Qualification Program
Contact us at: CDER-BiomarkerQualificationProgram@fda.hhs.gov