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Resource Library / Utilization of High Sensitivity Proteomics NULISA HT Panels for Clinical Biomarker Profiling: Assay Qualification and Regulatory Consideration

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Utilization of High Sensitivity Proteomics NULISA HT Panels for Clinical Biomarker Profiling: Assay Qualification and Regulatory Consideration

This first-ever reported study demonstrates the rigorous qualification of NULISAseq high-throughput (HT) panels for clinical biomarker profiling across multiple biomatrices—highlighting Frontage’s leadership in delivering high-sensitivity, multiplexed, and regulatory-ready biomarker assay solutions.

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Validation of a 384 gene hybridization capture-based pharmacogenomics NGS panel: sensitivity, specificity, accuracy, and reproducibility in calling star alleles for drug metabolism genes
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Validation of a 384 gene hybridization capture-based pharmacogenomics...
​Frontage has developed a next-generation sequencing (NGS)-based method to rapidly deter...
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Biomarker and Alzheimer’s disease: role of high sensitivity assays and the applications
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Biomarker and Alzheimer’s disease: role of high sensitivity...
It has been said that the diagnosis of Alzheimer's disease enters the era of biomarkers. T...
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Testing of Carryover & After MRD Benchtop Stability for Pharmacokinetic Method Validation in Gyrolab Immunoassay Platform
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Testing of Carryover & After MRD Benchtop Stability for...
In this white paper, we show testing of two critical parameters for the method validation ...
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AAPS 2025: Establishing Linear Viscoelastic Region and Gelation Dynamics in Anhydrous Intra Nasal Gel: Rheological Insights Toward Optimized Patient-Centric Formulations
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AAPS 2025: Establishing Linear Viscoelastic Region and Gelation...
By defining the linear viscoelastic region and gelation dynamics, this work provides key i...
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Development of Stable Nanoemulsion Formulation as an Ophthalmic Drug Delivery System for Cannabinoids
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Development of Stable Nanoemulsion Formulation as an Ophthalmic Drug...
This study is aimed at developing a Nanoemulsion formulation of a poorly water-soluble and...
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Neurofilament Light Chain: Method Validation of Quantitation Using the Quanterix Simoa™ Platform and Potential Applications
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Neurofilament Light Chain: Method Validation of Quantitation Using...
In this study, we quantify Neurofilament Light Chain (NF-L) in human plasma, serum, and CS...
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STP 2025: Organ Weight Data Interpretation in Toxicology Studies
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STP 2025: Organ Weight Data Interpretation in Toxicology Studies
Organ weight analysis is a key endpoint in toxicology studies, but interpretation can be c...
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Gut Reaction: Human Microbiome Analysis Insights
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Gut Reaction: Human Microbiome Analysis Insights
The microbiome continuously shapes its environment through a complex set of interactions, ...
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IVRT Insights From Frontage CMC Experts
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IVRT Insights From Frontage CMC Experts
In this white paper, we detail IVRT methods pertaining to generic and innovator products a...
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Nonclinical Vehicle Formulations:HP-β-CD (Hydroxypropyl-Beta-Cyclodextrin) & The Risk of Hemolysis
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Nonclinical Vehicle Formulations:HP-β-CD...
Beta-cyclodextrin is a commonly used excipient in nonclinical vehicle formulations. In a r...
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Alignment on Laboratory Support for Clinical Trials
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Alignment on Laboratory Support for Clinical Trials
In this Q&A, Nan Zhang MD PhD, Vice President of Global Central Lab and Biomarker Services...
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Accurate Mass: The best solution for metabolite identification in discovery, development and clinical applications.
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Accurate Mass: The best solution for metabolite identification in...
In this paper, we review appropriate definitions and describe the theoretical basis of why...
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