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How are automation and connectivity driving better patient care?

Healthcare providers face seemingly contradictory demands: reduce costs, provide an efficient service to more patients, and improve quality of care. For Anatomical Pathology laboratories, automation and connectivity make it possible to achieve all three goals. In particular, advances in IHC automation continue to improve what was previously a manual process.

The most obvious benefit of automation for IHC laboratories is reduced labor costs and improved efficiency. With instruments now fully automating IHC from baking/dewax through to counterstaining, technicians are no longer tied to the bench. This helps laboratories meet increased demands while also managing reduced budgets.

Most importantly, automation enhances patient care. Modern instruments dramatically reduce diagnostic turnaround times with fast IHC stainers completing more slides and cases each day, patients receive a faster diagnosis. Their efficient operation also means laboratories can offer a wider range of complex diagnostic test to more patient for a more precise diagnosis. Finally, patients and pathologists benefit from the exceptional consistency that automation offers by removing much or the human-derived variability that occurs with manual staining.

Laboratory connectivity also improves efficiency and patient safety by linking IHC stainers directly to a central Laboratory Information System (LIS). This connectivity should be encouraged as it cuts the time needed to create and transpose special slide labels for IHC. A bigger benefit is the elimination of identification errors that occur whenever labels are transferred or identifiers transposed.

The final aspect of automation that’s driving improvement through innovative laboratories is specimen tracking systems. Use of systems that confirm patient ID throughout the histology process should be encouraged. Their biggest contribution is to patient care. By systematically checking and confirming patient IDs at every stage, specimen tracking systems can virtually eliminate the patient mix-ups that lead to adverse patient outcomes including unnecessary surgery or delayed treatment. These systems also offer immediate efficiency gains by eliminating manual work. They further collect and report workflow data to facilitate Lean workflow and continuous improvement.

With automated systems cutting costs and improving patient care, it is clear that advances in automation for IHC and throughout the laboratory will be a vital tool for meeting modern healthcare challenges.

Why are automated tests so critical for theranostics?

Traditional cancer treatments are limited by the necessity to target a range of genetically diverse tumors, in a range of patients with vastly different immune and metabolic responses. Theranostics (or companion diagnostics) aim to personalize cancer treatment by identifying specific patients from a larger group who may benefit (or respond) to a closely targeted drug therapy.

The best known theranostic example targets Human Epidermal Growth Factor Receptor type 2 (HER2) in breast cancer. Detection of HER2 oncogene amplification, or protein overexpression, indicates a more aggressive form of breast cancer. The drug Herceptin® has been shown to be beneficial to HER2 positive patients, but offers no advantage to HER2 negative patients. Automated systems to assess HER2 status allow oncologists to offer Herceptin® only those patients who will respond to the treatment.

Fully automated theranostic kits play an important role in the increasing number of theranostic tests available. As theranostic tests effectively determine treatment, they are subjected to higher regulatory standards than standard IHC testing. Theranostic kits help ensure consistency as they are complete systems with the necessary reagents, controls and a pre-defined protocol for a particular automated instrument. The control slides are particularly vital as they indicate validity of the test by demonstrating HER2 expression of differing intensities (e.g. 0, 1+, 2+ and 3+).

A vision for high-quality IHC and ISH.

At Leica Biosystems our vison is to advance cancer diagnostics and improve lives. One way we can achieve this vision is by helping improve staining quality. As we recognize that IHC and ISH quality doesn‘t begin at the stainer, this series looks at many different aspects of staining quality, and considers how future tests will influence improved diagnosis.

This reference document is presented as a service to health care professionals by Leica Biosystems and has been compiled from available literature. Although every effort has been made to report faithfully the information, Leica cannot be held responsible for the correctness. This document is not intended to be, and should not be construed as medical advice. For any use, the product information guides, inserts and operation manuals of the various drugs and devices should be consulted. Leica Biosystems and the editors disclaim any liability arising directly or indirectly from the use of drugs, devices, techniques or procedures described in this reference document.

Copyright © by Leica Biosystems Melbourne Pty Ltd, Melbourne, Australia, 2016. LEICA and the Leica Logo are registered trademarks of Leica Microsystems IR GmbH. 95.14107 Rev A ∙ 04/2016