OncoMark Announces Results of Key Studies on Clinical Performance of Prognostic Test for Early Stage Breast Cancer
OncoMark Ltd, an Irish diagnostics company, today announced the results of two key studies on the clinical performance of its OncoMasTR test.
OncoMasTR is a gene expression test for early stage breast cancer prognosis. The test can determine the risk of recurrence of the disease for patients over a 10 year period, post-surgery.
The results of both studies, carried out on over 1,000 tumour samples, demonstrate that the OncoMasTR test can accurately identify a significant majority of patients with early stage breast cancer, who can forgo chemotherapy as part of their treatment, thereby avoiding associated side effects for the patient and unnecessary healthcare costs.
In the first study, involving 648 patients from the TransATAC clinical trial cohort, excellent performance was demonstrated across a number of key clinical parameters including the accurate identification of a significant majority of patients with node-negative disease for whom chemotherapy can be avoided.
In this study those classified as high risk by OncoMasTR were 4 times more likely to experience recurrence of cancer compared to those classified as low risk.
In addition this study demonstrated that that the prognostic power of the OncoMasTR test remained significant beyond 5 years after the initial diagnosis, in both lymph node-negative patients and those with a more aggressive form of the disease (1-3 involved lymph nodes).
In the second study, involving a cohort of 403 early stage breast cancer patients from 10 Irish hospitals, an independent subset of the TAILORx clinical study, the OncoMasTR test reclassified a majority of patients, who had previously been identified as intermediate risk patients by the market leading Oncotype Dx test, to low risk.
Patients classified as low risk had an extremely low incidence of recurrence and the OncoMasTR test accurately classified patients who had a recurrence into the high risk category.
The results of both studies were recently presented by OncoMark at the 2018 American Society for Clinical Oncology (ASCO) annual meeting held in Chicago.
Des O’Leary, CEO, OncoMark, said, "We had a very successful ASCO meeting this year and are extremely satisfied with the positive feedback to the data we presented. We received significant endorsement and support from the clinical and scientific communities for our plans to bring the OncoMasTR test to the market.”
He added, “In addition to the excellent clinical performance presented, the OncoMasTR test has been designed to be the most cost-effective test on the market with just three genes and can be performed using standard laboratory equipment in routine molecular pathology laboratories.”
He concluded, "We will now focus on executing on our plans for CE marking and launch of the OncoMasTR test in Q3 2018.”
OncoMark a spin-out from UCD’s School of Biomolecular and Biomedical Science is headquartered at NovaUCD, the Centre for New Ventures and Entrepreneurs at University College Dublin.