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  • OncoFREE
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.

What is OncoFREE®?

Information contained in a gene is delivered in the form of RNA.
Analyzing gene expression using RNA sequencing data allows accurate characterization of
cancer cells and prediction of cancer metastasis.

  • OncoFREE® is a test that analyzes the expression levels of 179 breast cancer-related genes using the RNA
    extracted from breast cancer tissues, based on which, it can predict the metastasis risk.
  • Since the test results enable us to predict metastasis risk of cancer, it helps to establish an appropriate post-surgical
    treatment plan.
Clinical usefulness of OncoFREE®?

A clinical validation with 413 Korean patients found a significant difference in the recurrence rate
between the high-risk group and the low-risk group.

  • Patients in the high-risk group had 6.57 times higher risk of metastasis than those in the low-risk group.
  • Among patients 50 or younger, those in the high-risk group had 7.79 times higher risk of metastasis than those in the low-risk group.
  • Overall Results (n=413)
    Overall Low Risk
    (n=269, 65.1%)     		High Risk
    (n=144, 34.9%)
    5-year Metastasis
    - free Survival     		97.0% 77.8%
    10-year Metastasis
    - free Survival     		93.2% 64.4%

    Reference: Lee HB et al., Clinical Cancer Research, 2020

  • Patients at Age ≤ 50
    (n=260, 63%)
    Age ≤ 50 Low Risk
    (n=176, 67.7%)     		High Risk
    (n=84, 32.3%)
    5-year Metastasis
    - free Survival     		97.7% 79.8%
    10-year Metastasis
    - free Survival     		94.3% 65.3%

    Reference: Lee HB et al., Clinical Cancer Research, 2020

Special feature of OncoFREE®:
reflection of the characteristics of breast cancer in Koreans

Breast cancer shows different trends in different countries according to various factors.
Breast cancer incidence in the USA is high in elderly post-menopausal women, whereas it is the highest in
women around the age of 50 in Korea.

  • Because OncoFREE® was developed using Korean breast cancer samples, it can better reflect the characteristics of
    breast cancers in Koreans.
  • OncoFREE® also gained high predictive power for patients under the age of 50 by utilizing more patient data under the age of
    50 during the development process.
Application of OncoFREE® results

Chemotherapy is effective in only about 20% of hormone receptor-positive early-stage
breast cancer patients.

  • Application of OncoFREE® results allows us to objectively categorize patients into those that are less likely to need chemotherapy
    due to low risk of metastasis in the absence of chemotherapy and those that need chemotherapy despite the occurrence of
    adverse effects.
  • OncoFREE® predicts risk of metastasis risk using Dl (Decision Index™).
Who are tested with OncoFREE®?

Among patients who received breast cancer surgery, those who will receive hormonal therapy and have no indication
for HER2-targeted therapy are eligible for this test.

  • Early stage breast cancer : 0.5cm < size of
    invasive cancer ≤ 5cm
  • Hormone receptors positive (ER(+)/PR(+))
  • No axillary lymph node metastasis (N0)
  • HER2 negative (HER2(-))

This test is based on the study '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',
the performance of the test was compared between low-risk and high-risk groups, and the 10-year distant metastasis-free survival rate was 93.
2% and 64.4%, respectively (hazard ratio 5.86), demonstrating some clinical significance of the test results.
However, this test requires further multicenter validation and follow-up studies for clinical validity.

If you have any further questions,
please contact DCGEN.

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