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Histopathology/IHC

Custom IHC assay development and validation

ÃÛÌÒ´«Ã½ specialises in custom IHC assay development and validation, offering a bespoke approach that caters to the unique needs of each clinical trial.

 

Our comprehensive digital pathology capabilities enhance analysis precision, facilitating critical biomarker studies from clinical trials to IVD submissions. ÃÛÌÒ´«Ã½ empowers partners with tailored, end-to-end solutions, driving the advancement of precision medicine and improving patient outcomes.

Global IHC solution

ÃÛÌÒ´«Ã½ ensures the highest standards of quality and efficiency through a global network of CAP-accredited laboratory facilities in the US, Ireland, and China. All operate with state-of-the-art instrumentation, coupled with harmonised analytical platforms, SOPs, QC materials & reagents to support large global studies

ÃÛÌÒ´«Ã½'s global network of IHC solutions delivers you:

 

Consistency and standardisation across regions 

IHC results are highly sensitive to variability in technique, reagents and interpretation. We offer standardized protocols, validated antibodies, and centralized QA/QC processes ensuring consistency in results across all regions¡ªcritical for multi-site trials and regulatory submissions.

Efficient turnaround times

Our strategically located network of laboratories enable faster sample processing and turnaround times, avoiding delays caused by international shipping or customs.

Robust data for regulatory & companion diagnostic (CDx) submissions 

ÃÛÌÒ´«Ã½¡¯s validated network with regulatory-grade quality systems (e.g., CAP/CLIA,) supports global regulatory filings and CDx co-development efforts.

Local expertise with global coordination 

We combine global oversight with local pathologists' contextual understanding, which improves accuracy while maintaining consistency.

Integrated data and reporting systems

ÃÛÌÒ´«Ã½¡¯s harmonised digital pathology platforms and data systems allow for integrated reporting, remote review, and centralized data access, delivering complete visibility and transparency. 

Tailored IHC assay development and validation

ÃÛÌÒ´«Ã½¡¯s Specialty Labs create custom IHC assay development and validation strategies, catering specifically to the unique requirements of each program. This bespoke service enables retrospective and prospective analysis. Depending on the needs of a program, we can customize IHC assays for both retrospective and prospective analysis of clinical trial specimens, facilitating comprehensive biomarker studies.

State-of-the-art IHC platforms and digital pathology capabilities

To support these tailored strategies, ÃÛÌÒ´«Ã½ utilizes an advanced array of automated IHC platforms and digital pathology tools across our global network of laboratories:

  • Automated IHC platforms: Our suite includes the Ventana Benchmark ULTRA, Leica Bond III, Dako Omnis, and Link 48, each chosen for their capability in performing assay optimization and running clinical trial assays with high precision and efficiency.
  • Digital pathology integration: ÃÛÌÒ´«Ã½'s digital pathology capabilities are cutting-edge, featuring digital scanning (Aperio platforms), image annotation, and web-based virtual slide review. This integration allows for detailed analysis and consultation with board-certified pathologists, enhancing the depth and accuracy of IHC assay results.
     

Your partner for precision medicine

This comprehensive approach to custom IHC assay development and validation, combined with our sophisticated IHC platforms and digital pathology capabilities, positions ÃÛÌÒ´«Ã½ as a leader in delivering specialised pathology services. Our focus on scientific rigor, technical excellence, and adherence to design control principles underscores our commitment to providing our partners with the insights needed to advance their clinical trials.

Through close collaboration, ÃÛÌÒ´«Ã½ empowers researchers and sponsors to uncover biomarker data, offering a tailored, end-to-end solution from assay development to regulatory submission. With ÃÛÌÒ´«Ã½, sponsors have a partner that not only understands the complexities of IHC assays but also shares their goal of improving patient outcomes through the advancement of precision medicine.

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