Our Solutions

End-to-End Companion Diagnostics Solutions

From biomarker discovery to regulatory submission — we support every stage of companion diagnostics development.

CDx Development

Companion Diagnostics Development

We partner with pharmaceutical companies to develop and validate companion diagnostics that accelerate drug development timelines and support regulatory submissions worldwide. Our dual-platform approach ensures that the right diagnostic strategy is matched to each clinical scenario — from rapid screening to comprehensive molecular profiling.

1

Biomarker Assay Development & Validation

Rigorous assay development and clinical validation on our dual-platform systems, designed to meet regulatory standards.

2

Multi-Center Clinical Trial CDx Deployment

Standardized deployment of CDx across global multi-center trials, ensuring consistent results regardless of location.

3

Regulatory Submission Support

Comprehensive documentation and regulatory strategy for FDA, EMA, NMPA, and other major regulatory bodies.

4

Quality Management & Standardization

End-to-end quality management ensuring reproducible, standardized results across all sites and platforms.

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Assay Development

Rigorous development and validation on dual-platform systems

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Global Deployment

Consistent results across multi-center clinical trials worldwide

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Regulatory Support

FDA, EMA, NMPA submission strategy and documentation

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Standardized Workflow

Unified protocols across all sites — no variation between centers

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On-Site Deployment

Deploy in resource-limited areas without specialized laboratories

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Rapid Enrollment

3–4 hour turnaround for fast patient enrollment decisions

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Centralized Data

Unified data management and real-time reporting dashboard

Global Support

Global Multi-Center Clinical Trial Support

Decentralized clinical trials demand diagnostics that work everywhere — not just in specialized laboratories. Our PCR POCT and nanopore platforms are designed for global deployment, enabling consistent, standardized companion diagnostics across sites in developed and emerging markets alike.

From patient enrollment screening to comprehensive molecular profiling, our dual-platform approach ensures that every site — whether in a major research hospital or a resource-limited community clinic — can deliver the same quality of diagnostic results.

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The Right Platform for Every CDx Scenario

Use PCR POCT When:

  • → Time-sensitive enrollment decisions are critical
  • → Sample quantity is limited (e.g., core needle biopsy)
  • → Site lacks specialized molecular laboratory infrastructure
  • → Screening for known hotspot mutations or fusion genes
  • → High-volume patient throughput is required

TAT: 3–4 hours | Sample: 1 FFPE section | Lab required: No

Use Nanopore When:

  • → Comprehensive molecular profiling is required
  • → RNA fusion gene validation or quantification is needed
  • → Structural variant or methylation analysis is part of the CDx
  • → Biomarker discovery alongside clinical validation
  • → Single-sample multi-omics approach is preferred

TAT: Same-day | Sample: Low input | Lab required: Optional

Let's Build Your CDx Strategy Together

Whether you're in early biomarker discovery or preparing for regulatory submission, we're here to help.

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