Biopharma & Research

Clinical Trial Genomics Services

Accredited centralised genomic testing and companion diagnostic support for clinical trials across Hong Kong and Asia-Pacific.

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What We Offer

Genomic Services for Clinical Trials

From assay development through data delivery, we act as your dedicated genomics central laboratory partner.

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Companion Diagnostic Development

Design and validate NGS-based companion diagnostic assays aligned with your drug programme. We support IVD development workflows and regulatory dossier preparation.

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Tumour Profiling & Biomarker Testing

Comprehensive somatic mutation profiling, TMB, MSI, and gene fusion analysis on FFPE or liquid biopsy specimens to stratify patients and define eligibility criteria.

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Germline & Pharmacogenomic Testing

Hereditary variant screening and PGx panels to support patient safety monitoring, dose optimisation, and inclusion/exclusion criteria in early-phase trials.

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Centralised Reference Laboratory

Single accredited laboratory hub (GenQA / UK NEQAS) for multisite clinical trials across Greater China and Asia-Pacific, ensuring consistent pre-analytical and analytical standards.

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Bioinformatics & Data Delivery

Standardised variant calling pipelines with QC-flagged VCF/report outputs delivered in sponsor-compatible formats. LIMS integration and secure data transfer supported.

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Regulatory & Quality Support

ISO 15189-aligned SOPs, chain-of-custody documentation, and audit-ready records to support IND, CTA, and GCP inspection requirements.

How It Works

From Protocol to Data Delivery

Protocol Review

We review your trial protocol and biomarker strategy to recommend the optimal testing approach and specimen requirements.

Assay Setup & Validation

Analytical validation of selected panels against your sponsor-specified performance criteria, with full documentation.

Site Onboarding

Specimen collection kits, requisition forms, and cold-chain logistics coordinated with each investigator site.

Testing & Reporting

Accredited testing with sponsor-branded or standard reports issued within agreed turnaround times.

Data Integration

Secure delivery of structured data files to your EDC, CTMS, or data management team.