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BIORI insights · Guides · Reagent strategy · QC know-how

Resources & Insights

Technical guides and reagent insights from BIORI for molecular diagnostics, NGS, mRNA and biopharma QC.

Molecular diagnosticsblood based molecular profiling reagent strategy cover

Blood-Based Molecular Profiling Reagent Strategy for Diagnostics

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.

6 min readRead
mRNA & IVTmrna manufacturing raw material strategy cover

mRNA Manufacturing Raw Material Strategy After Capacity Shifts

Recent mRNA manufacturing capacity shifts highlight why raw material strategy matters. This guide covers GMP-grade IVT enzymes, capping, DNase cleanup, QC and OEM planning for resilient RNA programs.

6 min readRead
Molecular diagnosticspharmacogenomic testing reagent strategy clinical diagnostics cover

Pharmacogenomic Testing Reagent Strategy for Clinical Diagnostics

Foundation Medicine’s new collaboration with Fulgent Genetics highlights rising clinical demand for pharmacogenomic testing. This guide explains reagent, QC and OEM considerations for diagnostic teams.

4 min readRead
Molecular diagnosticscfdna mrd testing reagent qc guide cover

cfDNA MRD Testing Reagent Strategy for Molecular Diagnostics

CareDx’s Naveris acquisition highlights rising interest in cfDNA MRD testing. This guide explains reagent, assay QC, sample prep and OEM considerations for molecular diagnostics teams.

5 min readRead
Molecular diagnosticsivd reagent quality documentation oem guide cover

IVD Reagent Quality Documentation for OEM Programs

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

5 min readRead
Molecular diagnosticsautomated ivd reagents respiratory panels cover

Automated IVD Reagents for Respiratory Panels: QC and OEM Lessons

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.

5 min readRead
NGS & genomicsngs sample prep reagent strategy qc codex cover

NGS Sample Preparation for Molecular Diagnostics: Reagent Strategy and QC

A practical guide to NGS sample preparation for molecular diagnostics, covering input QC, library prep reagent selection, workflow consistency, and OEM considerations.

5 min readRead
Biopharma QCresidual dna testing gene therapy manufacturing qc guide cover

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

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

5 min readRead
mRNA & IVTmrna bird flu vaccine ivt enzymes qc guide cover

mRNA Bird Flu Vaccine IVT Enzymes and QC Guide

Explore the mRNA bird flu vaccine workflow, from GMP-grade IVT enzymes and capping to residual DNA and HCP testing for biopharma QC.

8 min readRead
NGS & genomicsEnzyme Based Library

Enzyme-Based Library Preparation: The Genetic Scissors Driving the NGS Revolution

Enzyme-based library preparation is reshaping next-generation sequencing by simplifying DNA fragmentation, improving automation compatibility, and reducing sample loss. This article explains how enzymatic fragmentation is driving the NGS revolution.

7 min readRead
Molecular diagnosticsqPCR Results Analysis

qPCR Results Analysis: Amplification Curves, Melt Curves and Ct Values

How to interpret qPCR results: check controls, read amplification plots and Ct (Cq) values, troubleshoot curves and melt peaks, and calculate efficiency and ΔΔCt.

19 min readRead
Molecular diagnostics12 Golden Rules for PCR Primer Design

12 Golden Rules for PCR Primer Design

Use 12 practical PCR primer design rules to improve specificity, amplification efficiency and assay reliability while reducing dimers and off-target products.

5 min readRead
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