Digital Pathology Solution Now Customized for Breast Cancer Diagnostics

A tissue-staining analysis tool has been made accessible within a digital pathology system and has been customized for breast cancer biomarkers.

Dako Denmark A/S (Glostrup, Denmark), an Agilent Technologies company, and Omnyx, LLC (Pittsbugh, PA, USA), a joint venture of General Electric Healthcare and the University of Pittsburgh Medical Center, are now providing a newly developed clinical image analysis system for digital pathology in Europe. Dako has been using its expertise in staining and image analysis to develop algorithms that are incorporated into the Omnyx integrated digital pathology platform as part of Omnyx’s aim of providing pathologists with a comprehensive workflow. Now, also Dako’s “HercepTest” image analysis tool for tissue-stained slides is accessible in the Omnyx system and specifically customized for Dako’s breast cancer prognostic markers.


HercepTest is a semiquantitative immunohistochemical assay for specific determination of HER2 (c-erbB-2 onco-protein) overexpression. It is used for breast cancer tissues routinely processed for histological evaluation; also for formalin-fixed, paraffin-embedded (FFPE) cancer tissue from patients with metastatic gastric or gastroesophageal junction adenocarcinoma. HercepTest is indicated as an aid in the assessment of breast and gastric cancer patients for whom trastuzumab (Herceptin) treatment is being considered, and for breast cancer patients for whom pertuzumab (PERJETA) or ado-trastuzumab emtansine (KADCYLA) treatment is being considered.

By providing quantitative, reproducible results and more objective interpretation for HercepTest, the combined system improves accuracy and efficiency and enables a more confident diagnosis. “Omnyx envisions a future where image analysis and workflow empower pathologists to make confident clinical decisions ultimately leading to better patient care,” said Jim LaFrance, CEO of Omnyx. “Our partnership with Dako allows us to offer image analysis to clinicians who use Dako tests.”

Digital pathology holds much potential for standardizing test interpretation and enabling greater accuracy in tissue-based diagnostics. “With this offering, Dako and Omnyx support pathologists in making confident, efficient diagnoses based on both subjective and quantitative measures,” said Jakob Mohr Christensen, vice president of Global Marketing at Dako; “Additionally, the algorithms link digital scanners to Dako reagents and staining instruments, [providing] a complete and integrated solution.”

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Omnyx, LLC
Dako