OncoMasTR is a novel prognostic assay for early stage breast cancer currently being developed by OncoMark. This multi biomarker panel will determine the risk of recurrence for early breast cancer patients as either high or low risk. This assay will aid the clinicians to determine the best treatment options for their patients.
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. In the EU and USA, this represents 270,000 patients annually. Some patients are diagnosed with either early stage (contained within the breast) or later stage (spread to lymph or other organs).
Reccurence develops in~ 30% of early stage breast cancers within 10 years and, therefore, require aggressive chemotherapy, but it is difficult to differentiate between those whose disease will or will not recur. Currently the majority of early stage breast cancer patients are treated with chemotherapy, despite many not benefiting from such treatment, thereby exposing these individuals to severe side effects.
OncoMasTR qPCR assay test performed on 7 genes (+ 4 control genes) which will aid doctors to determine clinical treatment. On a large set of clinical samples tested to date, the assay yielded:
(1) binary output (low or high risk of recurrence), giving doctors a yes/no decision aid
(2) highly accurate results that reflect the true recurrence rate, detecting 67% of low risk patients.
Therefore, the OncoMasTR assay should give significant results in terms of both output format and assay performance.
User benefits of OncoMasTR will be that it will help the clinician to determine a course of treatment for their patients, avoid unnecessary chemotherapy for the patient and reduce healthcare costs.
Biomarker Discovery: Originally developed by researchers in Trinity College Dublin (TCD) and University College Dublin (UCD). The central hypothesis was to identify upstream 'drivers' of breast cancer progression, rather than 'passenger' genes. Identification of upstream drivers would represent a more accurate and reliable indicator of tumour progression compared to other signatures. (Lanigan et al., 2015, J FEBS in press)
Validation; Initial validation was on a large breast cancer cohort of retrospective samples. The qRT-PCR signature is prognostic at 5 and 10 years for both recurrence-free survival (RFS) and, in particular, DMFS, which is the key metric used for such commercially relevant prognostics.
For 10 year DMFS, 33% of patients are allocated as high risk with a 28% risk of recurrence, whereby 67% of patients are classed as low risk with 3% risk of recurrence. Specificity and sensitivity were assessed via ROC analysis, giving excellent AUC values of 0.798 in respect to DMFS, which indicates the prognostic potential of this assay. Therefore, OncoMasTR shows statistically significant prognostic performance when tested on clinical samples.