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Blood-Based Molecular Profiling Reagent Strategy for Diagnostics

Blood-based molecular profiling reagents strategy for diagnostics with cfDNA NGS qPCR and QC workflow visuals

Caris’ NYSDOH application for a blood-based molecular profiling test highlights reagent and QC priorities for cfDNA extraction, NGS library prep, qPCR verification and OEM diagnostics.

IVD Reagent Quality Documentation for OEM Programs

IVD reagent quality documentation OEM guide with batch records QC reports CoA and traceability visuals

New FDA Form 483 response guidance highlights documentation discipline. This guide explains what IVD reagent OEM teams should prepare for QC, CoA and traceability.

Automated IVD Reagents for Respiratory Panels: QC and OEM Lessons

Automated IVD reagents for respiratory panels with nucleic acid extraction PCR reagents and QC workflow

Applied BioCode’s new FDA-cleared KingFisher extraction workflow for its respiratory panel highlights why automated IVD reagents need robust QC, OEM documentation and platform compatibility.

Residual DNA Testing for Gene Therapy Manufacturing: A Practical QC Guide

Residual DNA testing for gene therapy manufacturing practical QC guide with qPCR analysis, viral vector and DNA visualization

A practical guide to residual DNA testing in gene therapy and biomanufacturing QC, covering method selection, sample prep, HCP/HCD risk, and supplier considerations.