Community Research and Development Information Service - CORDIS


OncoMasTR Report Summary

Project ID: 698630

Periodic Reporting for period 1 - OncoMasTR (OncoMasTR - Novel Prognostic Assay for Early Stage Breast Cancer)

Reporting period: 2016-02-01 to 2016-11-30

Summary of the context and overall objectives of the project

Breast cancer is the most frequently diagnosed cancer in women (25%) with 1.6 million new cases annually worldwide and increasing by around 1.5% each year. Due to the advent of mammographic screening across the EU and worldwide over the last 30 years, the majority of newly diagnosed breast cancers are early stage, hormone receptor-positive (ER+), lymph node-negative (LN-) cancers (i.e. not spread beyond the breast). These patients usually undergo surgery to remove the tumour, followed by chemotherapy to remove any remaining tumour cells in their system to prevent recurrence of the disease. Whether or not to subject these patients to additional chemotherapy is an ongoing problem for clinicians. Besides the temporary effect on quality of life due to chemotherapy (nausea, hair loss, diarrhoea, constipation, appetite changes, sore mouth and eyes), there is an increased risk of death due to treatment alone, and also an increased risk of future cancer. It is estimated that 30% of women with early stage disease will go on to develop a recurrence after surgery, meaning that up to 70% of women with early stage breast cancer are treated with chemotherapy, despite not benefiting from such treatment, thereby exposing these individuals to severe side effects.
OncoMark Ltd are currently developing a novel breast cancer assay, called OncoMasTR, which has the potential to transform clinical practice and patient care. The OncoMasTR assay will help clinicians to determine which patients should not receive chemotherapy for early stage breast cancer thus avoiding unnecessary chemotherapy. The OncoMasTR assay identifies 67% of the patient population as low risk for recurrence which will greatly reduce the numbers receiving chemotherapy but will not increase the risk of recurrence. Reducing the number of patients receiving cancer-related treatments will reduce the requirements for healthcare provision (doctors, nurses and hospital beds) and reduce economic hardship for patients who routinely lose working days due to chemotherapy-induced side effects. OncoMasTR will be a CE marked kit that can be used in hospital laboratories, and penetrate a global market. The OncoMasTR assay is more cost effective that the leading competitor assays and has markedly better performance that the market leaders. It could potentially save at least 15% of patients from receiving non-essential chemotherapy.

1. Globocan (
2. O’Brien, M.E. et al. Br J Cancer 95, 1632-1636 (2006)

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

For the OncoMasTR assay to be used by clinicians in hospital laboratories, it has to progress through 3 steps of product development; analytical validation, clinical validation/benchmarking and regulatory approval. The first 10 months of this project have been focussed on the analytical validation of the OncoMasTR assay on formalin-fixed paraffin-embedded (FFPE) materials. Work has been undertaken to identify and design the most suitable reagents and workflow for optimal performance of the assay (specificity, sensitivity, repeatability, reproducibility, limit of detection, PCR efficiency). This has yielded an initial prototype assay. Initial analytical validation on this prototype has been achieved. The next stage of the process is to perform clinical validation/benchmarking studies on clinical cohorts. OncoMark are currently looking to identify, engage, and apply for access to tissues from additional clinical cohorts to further increase market acceptance and, consequentially, uptake by relevant stakeholders.
Parallel to the technical work, we have been working on the commercial development of the OncoMasTR assay to ensure that the technology is market ready once the product development phase is complete. A first iteration of the OncoMark business plan has been created that details the product development route and commercialisation plan for the OncoMasTR assay for early stage breast cancer. We have also developed an IP strategy that is closely aligned to the business strategy of the company, in order to ensure protection of its IP assets and to create future value. Our aim is to ensure that we have freedom to operate in all countries that we enter, without impinging on other patents.
OncoMark have begun engaging with key opinion leaders (KOLs), oncologists, scientists, investors etc. to disseminate the benefits of the OncoMasTR technology over competitors. Finding external KOLs who will advocate for the OncoMasTR assay is key.
OncoMark’s CEO participated in the SME Instrument Innovator’s Summit in October 2016 where he received an award for best pitch in the Health field.
A project website has been launched and can be found at the following address:

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The OncoMasTR assay will have a positive impact on breast cancer patients (the ultimate end-user), clinicians, hospitals, national health services and the Government.

Patients’ needs: A key need for patients is to avoid unwarranted chemotherapy, where possible. Chemotherapy causes a diminished quality of life due to a series of side effects and confers a risk of death. The OncoMasTR assay identifies 67% of the patient population as low risk of recurrence. Therefore, this will greatly reduce the numbers receiving chemotherapy but will not increase the risk of recurrence. Treatment can also cause economic hardship for the patient, resulting from lost workdays due to chemotherapy-induced sickness. The OncoMasTR assay will help to alleviate this hardship for a large number of patients due to better performance than competing assays.

Clinicians’ needs: There is a clinical need for a more accurate, binary, prognostic test to determine the risk of recurrence for early stage breast cancer patients. Clinicians need a precise test that does not lead to ambiguous results or over treatment. The OncoMasTR assay can meet this need due to its more accurate binary output and better performance than predicate approaches, thereby facilitating better clinical decision making and reducing the number of patients requiring chemotherapy.

Clinical Centre / Hospital needs – Hospitals with limited budgets always need to reduce their operating costs but maintain excellent care for their patients. As there is a growing population of cancer patients, this will increase the requirements for healthcare provision, i.e. chemotherapy units / extra beds / doctors / nurses etc. in hospitals each year. The OncoMasTR assay can better allow clinics to prioritise the higher risk patients for further treatments and care.

Government needs – The overall healthcare cost burdens are increasing annually. For each new diagnostic test or drug therapy, the payers must make decisions about whether they will reimburse such costs. For this, they need demonstrated cost effectiveness to determine if the cost of implementation will offset or decrease the overall costs. We have carried out a cost-benefit analysis for the OncoMasTR assay, indicating a marked improvement over competitors.

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