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Aspects of clinical sample processing that can impact the multigene signature result for risk of cancer recurrence in breast cancer patients.

Engagement type

Enterprise Ireland Innovation Partnership


OncoMark is a diagnostics company focused on the development of novel panels of cancer biomarkers to aid treatment decisions and allow more tailored patient management, improving the quality of life for cancer patients.


Breast cancer is the most frequently diagnosed cancer in women, with more than 1.6 million new diagnoses worldwide every year. Several multigene assays have recently been developed to stratify early breast cancer patients by risk of recurrence and inform their treatment decisions. Many prognostic tests are developed and validated using well-controlled samples from clinical trials and can deviate from the real-life clinical scenario.

There are a number of aspects of clinical sample processing that end users face when translating the test’s clinical validation results to real-life processing that could potentially affect the results of multigene tests such as tumour heterogeneity and the concordance between paired core-needle biopsies and resected tumours, and tumour content requirement.

RCSI value-added

Dr Tony O’Grady (RCSI) leads a well-recognised laboratory with established molecular pathology capabilities. This lab carries out molecular testing on breast cancer samples from patients from a large, tertiary Irish hospital and were able to provide their expertise and knowledge in clinical sample processing.

“OncoMark’s novel breast cancer prognostic test is a powerful tool in identifying patients with low risk of recurrence who can safely forgo chemotherapy. Dr. Tony O’Grady and his team at RCSI played an important role in the validation of the test, and their expertise and guidance throughout this EI supported Innovation partnership helped to inform and refine the methodology for deployment of the test in clinical laboratories.”

Desmond O’Leary, CEO, OncoMark