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Subspecialties Histology, Oncology, Regulation and standards

Seamless Standardization

sponsored by Sakura

It is crucial that labs can rely on their slides for a seamless – and accurate – diagnosis. With many more commercial instruments focusing on flexibility and choice, these qualities are difficult to separate from subjectivity and complexity. To prepare for the future, we not only need standardization to reduce the chance of error and inaccuracy, but also for successful digital pathology practices and future AI developments. Sakura Finetek Europe has developed a new, advanced staining system – The Tissue-Tek Genie® – that allows laboratories to easily achieve standardization. Their novel system uses solely optimal scoring antibodies, enabling labs to produce optimal scoring slides with quicker, more streamlined results. This technology underlines their mission to advance cancer diagnostics by providing integrated solutions for anatomic pathologists and patients through their best-in-class innovation, quality, and customer care. 

Five years ago, NordiQC concluded that , al though 67 per cent of immunohistochemistry (IHC) slides were accurate enough to make a diagnosis, one out of three slides (33 percent) were, and are still, insufficient (1). The study – which analyzed more than 30,000 IHC slides between 2003-2015 – found that 30 percent of the staining results in the general module, and 20 percent in the breast cancer IHC module, were inadequate for diagnostic use. Some reasons for this insufficiency included underdeveloped antibodies, poorly calibrated ready-to-use products, erroneous epitope retrieval – and, most importantly – delayed standardization. Closer analysis revealed that most laboratories faced challenges with calibrating and validating IHC assays for optimal performance. In 2022, this performance was reflected on. Today, only one in five slides is insufficient for diagnosis (2). This jump may be attributed to factors such as access to sophisticated instrumentation for IHC, or publications that provide all stakeholders with guidelines on how to optimize IHC methods.

Regardless of the improvement, it was concluded that further IHC test accuracy and precision were required. Standardization is the key to perfection, and is the driving factor behind the Sakura Tissue-Tek Genie® – a fully automatic and non-flexible system that allows laboratories to achieve reproducibility and optimal only results. Standardization with the Genie also supports IVDR compliance and prepares for future developments in digital pathology and artificial intelligence. The technology is a huge step towards Sakura’s goal of being the first company to fully automate anatomic pathology. 

Sakura strives to connect all pathologists in the lab to their technique, and with their excellent implementation consultancy service – Bridge – they’ve done precisely that. Sakura Bridge suppor ts utilization of technology, and will guide you through the stages of preparation, implementation, and sustainment – regardless of your preferred solution. Their service will not only optimize workflow, but also help you achieve your own personalized goals. To further optimize partnership, Sakura Finetek Europe has created GenieOnline, a replenishment service that automatically reorders any consumables your Genie needs, eliminating worry about stock management. 

With The Tissue-Tek Genie®, Sakura Finetek Europe has set a new standard for tissue diagnostics – enabling laboratories to achieve consistent, optimal, and standardized results every time. The dream of standardization is now a reality 

What are the practical applications of your technology in the lab? 
 

  • Tissue-Tek Genie enables standardization of advanced staining of human, and formalin-fixed paraffin-embedded tissue 
  • Advanced capillary gap technology for whole slide coverage 
  • Pay-per-slide and transparent cost management 
  • 2hr 45 min predictable turnaround time for all biomarkers to support an efficient workflow 
  • Partnership with GenieOnline powers auto-replenishment for worry-free stock maintenance 
  • Optimal, ready-to-use reagents for standardized results that are prepared for future developments 
  • Closed system limits the exposure to chemicals, caters for a safer working environment, and allows easier IVDR compliance 
  • 30 fully independent stations allow maximum flexibility with limited downtime, and nullify splitting and sorting of cases
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  1. M Vyberg, S Nielson, Virchows Arch, 468, 19 (2016). PMID: PMC4751198. 
  2. S Nielson et al., Appl Immunohistochem Mol Morphol, [Online ahead of print] (2022). PMID: 36194495. 
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