Aligning CDx development with therapeutic clinical trials
Demonstrating clinical validity and utility for regulatory approval
Scaling assay production for global commercial launch
Maintaining stringent quality for patient stratification
Co-development of PCR-based (qPCR, dPCR) or NGS-based CDx assays.
Supplying primers, probes, and panels manufactured under ISO 13485 for CDx projects.
Providing reagents and data for analytical validation studies.
Deep understanding of the regulatory and development pathway.
A partner capable of supporting large-scale, global clinical trials.
Production standards that meet the demands of regulatory agencies.
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