Summary

While there is increased awareness and detection of breast cancer, we need better selection strategies to avoid giving unnecessary chemotherapy to patients who have early-stage disease. Now, cancer researchers in UCD and TCD have developed a new test which can reliably predict metastatic spread in breast cancer patients. This patented technology, called OncoMasTR, was then exclusively licensed into a UCD spin-out company (OncoMark) founded by one of the inventors, Professor Gallagher. OncoMark further developed and clinically validated the test in over 2,300 breast cancer patients, which led to the acquisition of the company by a large US firm who is now bringing this test to the clinic.

Once introduced, this test will give more tailored treatment options to early stage breast cancer patients and their supporting clinicians, and should allow for a substantial proportion (potentially up to 60%) of eligible patients to avoid unnecessary chemotherapy, resulting in better health outcomes and significant savings to the healthcare system.

Research description

In 2020, 2.3 million women were diagnosed with breast cancer, with 685,000 deaths globally. Here in Ireland, 1 in 8 women will develop breast cancer in their lifetime. Due to increased awareness and better screening, we are detecting and diagnosing cases much earlier than ever before.

Now, we need to develop better selection strategies to ensure women receive the most appropriate treatment. In particular, we want to avoid overtreating patients who have early-stage breast cancer with unnecessary chemotherapy (which can have many unpleasant side effects, like hair loss and vomiting) when hormone therapy alone would be sufficient. Chemotherapy may only benefit around 30% of women with early-stage breast cancer, yet it is often the default treatment.

To address this, cancer researchers in UCD and TCD collaborated to develop a new test which can reliable predict metastatic spread in breast cancer patients. The research, initiated between Professor Gallagher in UCD and Professor Bracken in TCD, used a technique called molecular profiling to identify a master set of “driver” genes in tumour tissue that are linked to breast cancer growth and spread. When combined with other clinical biomarkers, these drivers were shown to have the potential to become a superior tool for predicting the likelihood of the disease spreading around the body, compared with other pre-existing tests for early-stage breast cancer. 

A patent application relating to this discovery was filed in 2014, with patents subsequently awarded in both Europe and the US. The patented technology, named OncoMasTR, was then exclusively licensed into the UCD spin-out company, OncoMark, and developed into a diagnostic test that was CE-marked in 2018 (allowing for its clinical use within Europe).

Crucially, subsequent clinical validation studies of the OncoMasTR test were performed with tissues from over 2,300 breast cancer patients across Ireland, the UK and Austria. These clinical research studies showed that the OncoMasTR test was superior to currently used tools, including the most widely used molecular diagnostic in this setting worldwide.

In collaboration with Dr Catherine Mooney of UCD, the OncoMasTR test was also shown to have potential use in predicting the response of breast tumours to chemotherapy before surgical removal.

Research impact

Economic and technological impact

In 2007, Professor Gallagher co-founded OncoMark, a highly innovative spin-out diagnostics company from UCD. The new OncoMasTR technology created through the research, which can be used to improve the prediction of outcomes for early-stage breast cancer patients, was licensed on an exclusive basis to OncoMark. This was a major development, allowing the UCD spin-out to secure a highly competitive SME Instrument Award under the EU’s Horizon 2020 programme (€2.7 million; 1st ranked proposal out of 125 submitted, with only 3 funded) to facilitate analytical and clinical validation of the new diagnostic test. Moreover, it provided a key trigger for significant venture capital investment (of more than €6 million) to aid the commercial development of this new test.

In March 2021, OncoMark was acquired by a leading US diagnostics company, Cepheid, to bring the new test to the clinic. It is on track to being approved by the FDA and released onto the market later in 2024.

Since then, Professor Gallagher co-established a new company, OncoAssure, which recently developed another new gene-expression test for predicting aggressive prostate cancer, thereby repeating the successful approach demonstrated with the OncoMasTR story. The OncoMark journey has recently been profiled by the European Patent Office as a successful case story in technology transfer from academia in the cancer space, as well as its wider contribution to the innovation ecosystem in Ireland and further afield.

Health impact

The OncoMasTR test measures the expression of 6 genes and estimates the probability of distant recurrence for breast cancer patients (i.e. disease spread), thereby aiding clinicians in determining the best treatment options for patients. Critically, once adopted, the test should allow for a substantial proportion (potentially up to 60%) of eligible patients to avoid unnecessary treatment with potentially harmful chemotherapy. Accordingly, the OncoMasTR test can reduce anxiety that patients may face when deciding on optimal treatment course, and it can provide significant savings to the healthcare system due to reduced treatment.