OncoFREE®OncoFREE® is an in vitro diagnostics multivariate index assay (IVD-MIA) which predicts prognosis based on the risk for distant metastasis in hormone receptor- positive, HER2-negative early stage breast cancer patients with no axillary lymph node metastasis, by analyzing breast cancer tissue RNA expression data.
Traditionally, adjuvant treatment decisions for breast cancer were made based on pathologic information including pathologic staging using tumor size and presence of lymph node metastasis, and expression of hormonal receptors and HER2. However, advances in genomics research has led to incorporation of personalized genomic information in everyday clinical practice.
OncoFREE® is a breast cancer prognosis prediction tool which analyzes 179 genes carefully selected from public databases, utilizing the NGS (next-generation sequencing) technology that allows for a more sensitive analysis of more genes simultaneously with less RNA.
The OncoFREE® algorithm utilizing RNA expression levels of 179 genes derives the Decision IndexTM and the risk of distant metastasis, which allows decision making for the need for adjuvant chemotherapy.
Additional chemotherapy may be the strategy of choice to decrease the chance for distant metastasis in high-risk patients. However, there is no difference in distant metastasis without adjuvant chemotherapy in low-risk patients, preventing sufferings caused by adverse effects from chemotherapy in these patients.
To validate the prognostic value of OncoFREE®, Decision IndexTM (NGS-Prognostic Score[NGS-PS]) were derived from 413 ER-positive and HER2-negative invasive breast cancer samples with at least 60 months of follow-up. Kaplan-Meier curves of samples according to a Decision IndexTM cut-off value of 20 are shown below. Patients with a Decision IndexTM > 20 (high-risk group) showed 5.86 times higher risk of distant recurrence compared to those with a Decision IndexTM ≤ 20 (low-risk group) (A). Of note, subgroup analysis of patients with age ≤ 50 showed a 7.25 times higher risk of distant recurrence in the high-risk group compared to the low-risk group (B).
Reference: Lee HB, et al. Development and Validation of a Next-Generation Sequencing-Based Multigene Assay to Predict the Prognosis of Estrogen Receptor-Positive, HER2-Negative Breast Cancer. Clin Cancer Res. 2020 Dec 15;26(24):6513-6522. PMID: 33028590.
The original technology of OncoFREE® was supported by a grant of the Korea Health Technology R&D Project through the Korea Health Industry Development Institute (KHIDI), funded by the Ministry of Health & Welfare, Republic of Korea.