Biomarker Qualification 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)
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
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
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)
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LOI Withdrawn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)
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
DDTBMQ000036
Transbioline Workgroup
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
Anatomic features of bone as assessed by MRI
Prognostic biomarkers to identify patients more likely to experience knee osteoarthritis disease progression
DDTBMQ000039
AnaBios Corporation
Torsades de pointes proarrhythmia features
Safety biomarker score to assess pre-clinical risk identification of drug-induced pro-arrhythmia (torsades de pointes)
DDTBMQ000046
Fossa Consulting
Beat to beat restitution as assessed by ECG
Safety biomarker for pro-arrhythmia risk assessment
LOI withdrawn
DDTBMQ000049
Drs. Benesic and Gerbes
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
Glutamate Dehydrogenase (GLDH)
Safety biomarker to assess drug-induced liver injury
507 Update Response
10/25/2018
DDTBMQ000051
Perspectum Diagnostics Ltd.
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 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
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
DDTBMQ000057
COPD Foundation
Blood Eosinophil count as assessed by blood analyzer
- Predictive biomarker for subjects who are more likely to exhibit COPD exacerbations
- Predictive biomarker for subjects who are more likely to respond to anti-inflammatory treatments
1. LOI - Not Accepted
12/18/2017
2. LOI - Not Accepted 8/12/2019
DDTBMQ000070
CPATH TB Drug Regimens (CPTR)
Lipoarabinomannan as assessed by immunoassay
Pharmacodynamic response biomarker to assess treatment response in patients with pulmonary tuberculosis
DDTBMQ000071
CPATH Type1 Diabetes Consortium
Islet cell autoantibodies as assessed by immunoassay
Susceptibility/risk biomarker to identify individuals more likely to develop type 1 diabetes
DDTBMQ000074
FLUIDDA, Inc.
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
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)
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
DDTBMQ000076
Center for Studies of Addiction: University of Pennsylvania Perelman School of Medicine
rs678849, a SNP in ORPD1, as identified by genotyping assay
Predictive biomarker for certain subject’s opioid use disorder to enrich buprenorphine trials.
DDTBMQ000077
Rady Faculty of Health Sciences
University of Manitoba
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
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
DDTBMQ000079
Nerve Unit Massachusetts General Hospital
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
DDTBMQ000081
Critical Path Institute (CPATH)Predictive Safety Testing Consortium and Duchenne Regulatory Science
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
DDTBMQ000082
Perspectum Diagnostics
MRI Measured Proton Density Fat Fraction (MRI-PDFF) of Liver
Diagnostic enrichment biomarker for selecting patients for non-alcoholic steatohepatitis (NASH) trials
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.
DDTBMQ000084
Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium – NIMBLE
Four circulating biomarker panels for NASH
Diagnostic biomarker to enrich and to identify patients likely to have liver histopathologic findings of nonalcoholic steatohepatitis (NASH)
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.
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
DDTBMQ000089
Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium
Anatomic bone features
Prognostic enrichment imaging biomarker to identify individuals with a diagnosis of knee osteoarthritis who are likely to experience disease progression
DDTBMQ000090
Foundation for the National Institutes of Health (FNIH) Biomarkers Consortium
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
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.
DDTBMQ000094
TransBioLine
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 Response 04/12/2019
DDTBMQ000095
LITMUS
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)
DDTBMQ000096
IMI-TRISTAN Consortium
Contact: Gerry Kenna
Gadoxetate signal as measured by MRI
Safety biomarker indicating potential intrahepatic drug-drug interactions.
LOI Determination Letter 5/14/2021
DDTBMQ000097
Critical Path Institute (C-Path), Transplant Therapeutics Consortium (TTC)
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.
DDTBMQ000099
Resoundant, Inc.
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
DDTBMQ000100
University of Washington Department of Laboratory Medicine
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
DDTBMQ000101
Innovative Medicines Initiative (IMI) TransBioLine Drug-Induced CNS Injury (DINI) Work Package
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
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
DDTBMQ000104
IGEA Research Corporation
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)
DDTBMQ000105
PathAI, Inc.
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.
DDTBMQ000106
LITMUS
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
DDTBMQ000107
University of Washington Department of Laboratory Medicine
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.
DDTBMQ000108
Innovative Medicines Initiative TransBioLine - Drug-Induced Kidney Injury Work Package
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
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.
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
DDTBMQ000112
Foundation for the National Institutes of Health Biomarkers Consortium
Non-Invasive Biomarkers of MetaBolic Liver DiseasE (NIMBLE)
Ultrasound biomarkers
• Shear Wave Elastography (SWE) based Shear wave speed (SWS)
• Vibration controlled transient elastography (VCTE) based liver stiffness
• Vibration controlled transient elastography (VCTE) based controlled attenuation parameter (CAP)
• MRI Biomarkers
• MRI based PDFF
• MRI based cT1
• 2D MRE Based liver stiffness
• 3D MRE based liver stiffness
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)
DDTBMQ000113
Innovative Medicines Initiative (IMI)
TransBioLine
Contact: Lidia D. Mostovy
2/16/2021
5/14/2021
DDTBMQ000114
University of Florida
Department of Applied Physiology and Kinesiology
Contact: Dr. David Vaillancourt
6/4/2021
DDTBMQ000115
University of Maryland, Baltimore School of Pharmacy
Contact: Dr. Maureen Kane
7/27/2021
DDTBMQ000117
Histoindex
Contact: Anthony Lie
12/19/2022
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