Publications

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SCIENTIFIC PRESENTATION: Validated WES Assay for Biomarker Discovery and Clinical Development

Explores end-to-end WES workflows from validation to implementation.

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ARTICLE: Technical Considerations of Pharmacokinetic Assays for LNP‑mRNA Drug Products by RT‑qPCR

Guidance on developing and validating RT-qPCR assays for reliable pharmacokinetic analysis of LNP‑mRNA drug products.

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ABSTRACT: Optimizing Clinically Actionable Biomarker Detection in Advanced Cancers by Next Generation Sequencing (NGS) Panel and Specimen Type

Explores how NGS panels and sample types improve detection of clinically relevant biomarkers in CAR T-cell therapies for hematological cancers.

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TECHNICAL NOTE: Beta-Actin Housekeeping Gene - A Reliable Marker for Human DNA Detection in Blood and Serum

Evaluates beta-actin as a dependable internal control for specimen quality and molecular assay validation in clinical samples.

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ARTICLE: AAV Vectors in Gene Therapy Clinical Trials

Highlights the potential and challenges of AAV vectors in gene therapy, including immune response management and tissue targeting.

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ARTICLE: Spectral Flow Cytometry in CAR T-Cell Clinical Trials: Enabling Novel Therapies

Details how standardized spectral flow cytometry assays support reliable monitoring of CAR T-cell therapies and biomarker identification.

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SCIENTIFIC PRESENTATION: Strategies for the Modernization of Legacy Transfer Methods

Highlights approaches to modernize legacy assay transfer methods for improved reproducibility and efficiency.

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SCIENTIFIC PRESENTATION: Putting Cell Counting in Context (of use): Analytical Measurements Supporting Cellular Therapies

Explores how context of use influences cell counting and analytical measurements in cell therapy development and clinical evaluation.

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SCIENTIFIC PRESENTATION: RNASeq - Illuminating Biomarker Landscapes for Precision Medicine - A Comparative Exploration of Multiplex Gene Profiling Technologies

Examines RNASeq for biomarker discovery and its advantages over other multiplex gene profiling technologies in precision medicine.

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SCIENTIFIC PRESENTATION: Global Harmonization of PCR: An Initial Study with Six World Health Organization (WHO) Reference Strains

Details efforts to harmonize viral PCR assays using WHO reference strains to improve standardization and accuracy.

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ARTICLE: Routine Germline Sequencing Aids Decision-making in Cancer Care

Dr. Karina Eterovic discusses how germline sequencing and clonal hematopoiesis inform precision cancer diagnosis and treatment decisions.

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TECHNICAL NOTE: Pioneering Vaccine Trials - Unveiling the Science Behind Neutralizing Antibody Assessment

Highlights best practices for cell-based neutralizing antibody assays to ensure high-throughput, reproducible testing in vaccine and therapeutic trials.

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ARTICLE: Analytical measurements supporting cellular therapies

Explains how context of use (COU) influences accurate cell counting in cell therapy manufacturing, development, and clinical evaluation.

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SCIENTIFIC REPORTS: Extend the benchmarking indel set by manual review using the individual cell line sequencing data from the Sequencing Quality Control 2 (SEQC2) project

Contributed to extending the benchmarking indel set using individual cell line sequencing data to enhance sequencing quality control.

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TECHNICAL NOTE: SUN Probes From IDT Demonstrate Superior Results to VIC Probes in qPCR

Demonstrates how fluorophore selection impacts PCR performance, with SUN probes showing superior results.

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eBOOK: Defining Specificity within the ELISpot Assay

Details assay, donor, and antigen specificity considerations for ELISpot testing.

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ARTICLE: Initial Analysis of Viral Dynamics and Circulating Viral Variants During the mRNA-1273 Phase 3 COVE Trial

Presents analysis of viral dynamics and variant monitoring during Moderna’s COVE vaccine clinical trial.

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eBOOK: Vaccine Development in Clinical Trials

Explores key methods and best practices for clinical vaccine development.

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