| Critical Path Institute |
Alpha-synuclein seeding amplification assay |
For the application of binary assessment of α-syn SAA as an enrichment biomarker for patient selection in clinical trials investigating therapies that are intended to treat, prevent, or delay neurodegenerative disorders characterized by a common synuclein biology. |
8/19/2024: Letter of Support (PDF - 425 KB) |
Diane Stephenson, PhD |
| Nordic Bioscience |
PRO-C3 fragment of collagen III in plasma |
Prognostic biomarker for enrichment of clinical trials of solid tumors |
6/6/2023: Letter of Support (PDF - 391 KB) |
Daniel Guldager Kring Rasmussen, MSc, PhD |
| C-Path, PSTC |
Molecular Biomarkers: miR-217, miR-216a, miR-216b, and miR-375 |
Translational safety biomarkers to detect and monitor drug-induced pancreatic injury |
5/5/2023 Letter of Support (PDF - 158 KB) |
Refer to Predictive Safety Testing Consortium Website |
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Joint Head and Neck Radiotherapy-MRI Development Cooperative / MD Anderson Cancer Center
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Dynamic contrast enhanced magnetic resonance imaging (DCE-MRI) quantitative parameters, Ktrans and Ve, for monitoring of mandibular injury/osteoradionecrosis
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DCE-MRI Ktrans and Ve as exploratory monitoring biomarkers of osteoradionecrosis (ORN) in at risk patients with head and neck cancer (HNC) treated with radiation therapy |
11/23/21: Letter of Support (PDF - 137 KB) |
Dr. Stephen Lai |
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Nordic Bioscience A/S, Bristol Myers Squibb (BMS), University of Pennsylvania (UPENN)
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PRO-C6
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Heart failure with preserved ejection fraction (HFpEF)
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8/25/21 Letter of Support (PDF - 202 KB) |
Daniel Guldager Kring Rasmussen, MSc, PhD |
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International Progressive Multiple Sclerosis Alliance Fluid Biomarkers Implementation Team
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Plasma/serum neurofilament light (NfL) chains
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Assess response to treatment in clinical trials
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5/25/21 Letter of Support (PDF - 241 KB) |
Kathryn Smith |
| sRNAlytics, Inc. |
Isomicro-RNAs’ levels in blood as measured by assay |
As a monitoring biomarker, indicating progression of Huntington’s Disease in patients bearing the HD mutation |
1/17/19: Letter of Support (PDF) |
David W. Saltzman |
| NeuroRx, Inc. |
Glx (Glutamine and Glutamate) in the brain as measured by Magnetic resonance spectroscopy |
As a pharmacodynamic biomarker, an objective imaging biomarker measure of depression to be used in conjunction with current measures of depression (rating scales) in clinical trials. |
4/3/18: Letter of Support (PDF) |
Johnathan C. Javitt |
| FLUIDDA, Inc. |
Functional Respiratory Imaging (FRI) of Lung and Airway Structural and Functional Parameters Measured by Low-dose High-definition Volumetric Computerized Tomography (HDCT) Scans and Quantitative Imaging Technology |
Exploratory pharmacodynamic/response (PD/R) biomarkers for use in bioequivalence (BE) studies of locally-acting orally-inhaled drug products (LAOIDP) in clinical trials of patients with conditions of the lung |
1/10/18: Letter of Support (PDF) |
Jan De Backer |
| TBI Endpoints Development (TED) Initiative and Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) |
Glial fibrillary acidic protein (GFAP) and ubiquitin carboxyl-terminal hydrolase-L1 (UCH-L1) in blood |
Exploratory prognostic enrichment biomarkers to identify patients who are likely to develop persistent disability during the course of mild traumatic brain injury (TBI) clinical trials |
1/10/18:Letter of Support (PDF) |
Dr. Geoff Manley or view TED Initiative website and/or TRACK-TBI website |
| Health and Environmental Sciences Institute (HESI) Genomics Committee |
Genomic biomarker panel TGx-DDI |
Exploratory safety biomarker panel to facilitate safety genotoxicity assessment in nonclinical studies |
10/24/17; Letter of Support (PDF) |
Syril Petit or view the HESI committee website
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| TBI Endpoints Development (TED) Initiative and Transforming Research and Clinical Knowledge in TBI (TRACK-TBI) |
Cortical contusions and diffuse axonal injury, as measured by magnetic resonance imaging (MRI) |
Exploratory prognostic enrichment biomarkers to identify patients who are likely to develop persistent disability during the course of mild traumatic brain injury (TBI) clinical trials |
3/31/17: Letter of Support (PDF) |
Dr. Geoff Manley or view TED Initiative website and/or TRACK-TBI website |
| Safer and Faster Evidence-based Translation (SAFE-T) Consortium and Predictive Safety Testing Consortium (PSTC) |
urinary alpha-glutathione S-transferase (α-GST), urinary clusterin (CLU), urinary cystatin C (CysC), urinary Kidney Injury Molecule-1 (KIM-1), urinary neutrophil gelatinase-associated lipocalin (NGAL), urinary osteopontin (OPN), urinary albumin (ALB) and urinary total protein (TPRO) |
Exploratory safety biomarkers for monitoring drug-induced renal tubular injury in early clinical drug development |
11/23/2016: Letter of Support (PDF) |
Gary Steven Friedman, Stefan Sultana, Jean-Charles Gautier, John-Michael Sauer or view either the Critical Path Institute Website or the IMI SAFE-T Consortium Website
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| Safer and Faster Evidence-based Translation (SAFE-T) Consortium and Predictive Safety Testing Consortium (PSTC) |
Soluble biomarkers of endothelial cell injury and inflammation: E-Selectin, P-Selectin, sICAM-1, sICAM-3, sVCAM-1, thrombomodulin VEGF, CRP, GROa, IL-6, IL-8, IP-10, I-TAC, MCP-1, MIG, SAA and MIP-1a |
Exploratory safety biomarkers for monitoring drug-induced vascular injury (DIVI) in early clinical drug development |
11/7/2016: Letter of Support (PDF) |
Michael Lawton, Tanja Zabka, Brad Enerson, John-Michael Sauer or view either the Critical Path Institute Website or the IMI SAFE-T Consortium Website
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The Safer and Faster Evidence-based Translation Consortium (SAFE-T)
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Cytokeratin 18 (CK‐18), Total and Hyperacetylated High Mobility Group Protein B1 (HMGB1), Osteopontin, and Macrophage Colony-Stimulating Factor 1 Receptor (CSF1R)
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Exploratory Monitoring Biomarkers for Use in Drug Development as a Clinical Safety Assessment of the Risk of Drug-induced Liver Injury (DILI) Progression
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7/25/2016: Letter of Support (PDF)
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Drs. Gerd Kullak-Ublick, Sif Ormarsdottir, John-Michael Sauer or Douglas Keller or view either the Critical Path Institute Website or the IMI SAFE-T Consortium Website
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Mosaiques-diagnostics
GmbH
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CKD273
(Urinary Peptide Panel)
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Prognostic Enrichment Biomarker Panel for use in Early Stage Diabetic Kidney Disease
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6/14/2016: Letter of Support (PDF)
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Harald Mischak
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FLUIDDA
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Functional Respiratory Imaging (FRI) of Lung and Airway Structural and Functional Parameters Measured by Low-dose High-definition Volumetric Computerized Tomography (HDCT) Scans and Quantitative Imaging Technology
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Prognostic Biomarkers of Disease Progression and Pharmacodynamic Response for use in Idiopathic Pulmonary Fibrosis (IPF)
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6/6/2016: Letter of Support (PDF)
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Jan De Backer
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Xhale, Inc.
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2-Butanone in Human Breath
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Monitoring Biomarker to Evaluate Drug-Dosing Compliance on a Dose-by-Dose Basis
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11/19/2015:Letter of Support (PDF)
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Donn Dennis
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Memorial Sloan-Kettering Cancer Center, Medivation Inc., and Janssen Diagnostics, LLC
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Circulating Tumor Cell (CTC) Enumeration
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Disease Activity Biomarker for use in Metastatic Castration-resistant Prostate Cancer (mCRPC)
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9/25/2015: Letter of Support (PDF)
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Debra J. Rasmussen
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C-Path, Polycystic Kidney Disease (PKD) Outcomes Consortium
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MRI, Computerized Tomography (CT), or Ultrasound (US) Biomarker: Total Kidney Volume (TKV)
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Exploratory Prognostic Biomarker for Enrichment in Autosomal Dominant Polycystic Kidney
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4/23/2015: Letter of Support (PDF)
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Refer to Polycystic Kidney Disease Outcomes Consortium Web Site
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C-Path, CAMD
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Molecular Neuroimaging Biomarker: Dopamine Transporter (DAT)
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Exploratory Prognostic Biomarkers for Enrichment in Early Stage Parkinson's Disease Clinical Trials
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3/16/2015: Letter of Support (PDF)
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Refer to Coalition Against Major Diseases Web Site
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C-Path, CAMD
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Magnetic Resonance Imaging Biomarker: Low Baseline Hippocampal Volume
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Exploratory Prognostic Biomarkers for Enrichment in Early Stage Alzheimer's Disease Clinical Trials
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3/10/2015: Letter of Support (PDF)
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Refer to Coalition Against Major Diseases Web Site
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C-Path, Coalition Against Major Diseases Consortium (CAMD)
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Cerebral Spinal Fluid (CSF) Analyte Biomarkers: Aβ1-42, Total tau, Phosphotau
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Exploratory Prognostic Biomarkers for Enrichment in Early Stage Alzheimer’s Disease Clinical Trials
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2/26/2015: Letter of Support (PDF)
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Refer to Coalition Against Major Diseases Web Site
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C-Path, PSTC, Skeletal Muscle Working Group (SMWG)
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Serum and Plasma Biomarkers: Myosin Light Chain 3 (Myl3), Skeletal Muscle Troponin I (sTNI), Fatty Acid Binding Protein 3 (FABP3), Creatine Kinase, Muscle Type (CK-M, the Homodimer CK-MM)
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Early Clinical Drug Development
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1/22/2015: Letter of Support (PDF)
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Refer to Predictive Safety Testing Consortium Web Site
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Critical Path Institute's (C-Path) Predictive Safety Testing Consortium (PSTC), Nephrotoxicity Working Group (NWG)
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Urinary Biomarkers: Osteopontin and Neutrophil Gelatinase-associated Lipocalin (NGAL)
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Early Clinical Drug Development
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8/20/2014: Letter of Support (PDF)
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Refer to Predictive Safety Testing Consortium Web Site
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