What is GenesWell™ BCT
GenesWell™ BCT is a prognostic multigene test designed to help early-stage (Stage I or II) breast cancer patients make better treatment decisions after surgery. In the majority of early-stage breast cancer patients, the risk of recurrence and metastasis that would necessitate chemotherapy after breast cancer surgery is very low. GenesWell BCT allows patients and doctors to make informed treatment decisions and avoid unnecessary overtreatment. GenesWell™ BCT is the first breast cancer disease progression test approved by the Ministry of Food and Drug Safety in Korea on November 2, 2016 (Class III).
Who can participate in GenesWell BCT?
GenesWell™ BCT is intended for hormone receptor-positive (ER/PR+) and human epidermal growth factor receptor-negative (HER2-), with metastasis in fewer than three lymph nodes, and who have not received chemotherapy before surgery. This test examines RNA obtained from early-stage breast cancer patients to predict the likelihood of distant metastasis and ten-year survival rate. It helps differentiate patients with high survival rates without chemotherapy (low-risk) from those with low survival rates without chemotherapy (high-risk).
| Stage | Tumor Size | Positive Lymph Nodes | Metastasis |
|---|---|---|---|
| 1A | ≤ 5 CM | None | none |
| 1B | ≤ 5 CM | Fewer than 3 lymph nodes with micrometastasis |
none |
| 2A | ≤ 5 CM | Fewer than 3 lymph nodes with metastasis | none |
Reference: Eric Wong. Breast cancer pathogenesis and histological and molecular subtypes. McMaster Pathophysiology Review. Poster. December 2012.
GenesWell™ BCT is utilized to detect gene expression levels through Real-Time RT-PCR using LightCycler® 480 (Product License No. 07-1116) for 9 genes in early-stage breast cancer FFPE samples. The BCT score is calculated using an algorithm that incorporates clinical information. GenesWell™ BCT includes a total of nine genes: five proliferation genes (UBE2C, TOP2A, RRM2, FOXM1, MKI67), one immune gene (BTN3A2), and three reference genes (CTBP1, CUL1, UBQLN1).
| Gene Symbol | Gene Disclosure | |
|---|---|---|
| Proliferation Genes | UBE2C TOP2A RRM2 FOXM1 MKI67 |
Ubiquitin - conjugating enzyme E2C Topoisomerase (DNA) II alpha Ribonucleotide reductase M2 Forkhead box M1 Antigen identified by monoclonal antibody Ki - 67 |
| İmmunity Gene | BTN3A2 | Butyrophilin subfamily 3 member A2 |
| Reference Genes | CTBP1 CUL1 UBQLN1 |
C - terminal binding pretein 1 Cullin 1 Ubiquilin 1 |
| Proliferation Genes: | It is associated with the proliferation of cancer cells. The higher the number of these cells, the more likely cancer cells are to proliferate. |
| Immunity Gene: | Having a high amount of immune genes is associated with preventing the proliferation of cancer cells. |
| Reference Genes: | It is the group of genes used as standards to compare the relative expression of target genes. |
GenesWell BCT Results Determine a BCT Score:
A number between 0 and 10 for early-stage breast cancer.
Based on your BCT score, you and your doctor refer to the following ranges to interpret your results regarding early-stage invasive cancer.
BCT Score 0 - 3.99: The risk of cancer recurrence and distant metastasis is low. The benefits of chemotherapy are likely to outweigh the risks of side effects.
BCT Score 4.00 - 10: The risk of cancer recurrence and distant metastasis is high. The benefits of chemotherapy are likely to outweigh the risks of side effects.
GenesWell BCT Process
- Request for breast cancer confirmation and review
- Surgical Procedure
- Sample collection and delivery
- GenesWell™ BCT Test
- GenesWell™ BCT Report
- Treatment Decision