Periodic Reporting for period 2 - OncoMasTR (OncoMasTR - Novel Prognostic Assay for Early Stage Breast Cancer)
Reporting period: 2016-12-01 to 2018-01-31
OncoMark Ltd are 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 those patients at low risk of 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 than the market leaders.
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 business plan was created and presented to potential investors. A total of €2.1 million was successfully secured. News of the €2.1 million OncoMark investment was disseminated through a press release which featured in a large number of national and international publications. We are currently progressing a patent application, entitled ‘A method of predicting risk recurrence of cancer’, which was filed in August 2014 to ensure that we have IP protection in all countries that we enter, without impinging on other patents.
We have engaged with key opinion leaders (KOLs) to disseminate the benefits of the OncoMasTR technology over competitors. Extensive communication and dissemination activities were carried out by the OncoMark team. We presented posters detailing the development and validation of OncoMasTR at two conferences; ESMO in September 2017 and SABCS in December 2017. We also continued to disseminate OncoMark news through the website and social media platforms. OncoMark’s CEO, Mr. Des O’Leary has received two awards over the course of the grant; an award for best pitch in the Health field at the SME Instrument Innovator’s Summit in October 2016 and an Ireland's Champions of EU Research award from Enterprise Ireland in June 2017. In February 2017, OncoMark’s CSO Prof. William Gallagher, was the inaugural recipient of the Irish Association of Cancer Research (IACR) Cancer Research Medal which recognised his outstanding contribution to the cancer research community in Ireland.
Project website: www.OncoMasTR.com
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 the patient population at 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 / doctors 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. With improved risk stratification and lower costs versus competitors, the OncoMasTR assay will be significantly more cost-effective.