GMP-COMPLIANT, ISO-CERTIFIED DIAGNOSTIC DEVELOPMENT STARTS WITH US
- info7637144
- 3 days ago
- 2 min read
Bringing a diagnostic from concept to market takes a collaborative partner who understands your vision and can support your pipeline with accuracy, speed, and flexibility.
At MRN Diagnostics, we work closely with your team to build customized, compliant, and ready-to-perform solutions for your assay’s needs.
TAILORED TOOLS FOR EVERY STAGE
Our diagnostic development support includes a full selection of resources designed to streamline your workflow and reduce time to market:
Extensive biorepository of remnant and disease-state samples
Custom LDT specimen panels tailored to your assay validation goals
OEM test kit components, controls, and calibrators manufactured to your specifications
Ongoing QC and proficiency testing panels to maintain high-quality performance
TRUE COLLABORATION, PROVEN QUALITY
We do more than supply; We collaborate. From feasibility assessment to full-scale commercial manufacturing, our team works alongside yours to ensure complete alignment with your assay requirements, validation strategy, and regulatory objectives.Our in-depth MRNDx Product Pipeline guides your project from concept to launch, starting with product feasibility assessments to confirm performance specifications and manufacturing requirements, followed by custom product design and development, multi-platform assay validation, and clinical performance evaluations using targeted, IRB-approved specimen collections.
QUALITY ASSURED OEM MANUFACTURING
With our FDA-Registered, ISO 13485:2016-compliant manufacturing facilities, we produce in-process QC materials, verification panels, calibrators, and complete diagnostic kits, scaling from feasibility lots to full commercial runs. We also provide OEM manufacturing under your label, complete regulatory submission support, CLIA-compliant verification panels for product launch, and proficiency testing materials to ensure long-term accuracy in clinical use.
Every stage is supported by rigorous quality systems, detailed documentation, and a commitment to meeting your technical and regulatory needs. MRNDx delivers the consistency and confidence required to move your diagnostic innovations forward.
BUILDING BETTER DIAGNOSTICS TOGETHER
MRN Diagnostics is committed to helping you create the precise tools your assay needs to succeed. Submit a quote request or start a conversation at sales@mrndx.com. We are ready to support your next breakthrough.
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