The Oncotype DX test is a genomic tool that has transformed personalized cancer care. It serves as a diagnostic test, offering detailed insights to guide treatment decisions for specific cancer patients and optimize their outcomes.
Understanding the Oncotype DX Test
The Oncotype DX test is a genomic assay designed to analyze specific genes within a tumor tissue sample. Its primary purpose is to predict the likelihood of breast cancer recurrence and assess the potential benefit of chemotherapy. This is particularly relevant for patients with early-stage, hormone receptor-positive, HER2-negative breast cancer, as it helps tailor treatment plans.
Who the Test Helps
The Oncotype DX test is indicated for patients with early-stage, hormone receptor-positive (HR+), HER2-negative (HER2-) breast cancer. This includes individuals with lymph node-negative disease or 1-3 positive lymph nodes. The test provides information on recurrence risk and whether chemotherapy offers a benefit alongside hormone therapy. This helps avoid unnecessary chemotherapy and its side effects for patients unlikely to benefit.
How the Test Works and What Results Mean
The Oncotype DX test is performed on a tumor tissue sample, obtained during a biopsy or surgery. The sample is sent to a specialized laboratory for analysis. The test examines the activity of 21 specific genes within the tumor cells: 16 cancer-related and 5 reference genes.
Gene expression levels are used to calculate a “Recurrence Score” (RS), a numerical value ranging from 0 to 100. A lower Recurrence Score, 0-17, indicates a low risk of cancer recurrence and suggests that chemotherapy benefits may not outweigh the risks. An intermediate score, 18-30, indicates an intermediate risk of recurrence, and the benefit of chemotherapy is uncertain, requiring further discussion with the medical team. A high score, 31 or above, indicates a higher risk of recurrence, meaning adding chemotherapy to the treatment plan is likely beneficial.
Accessing the Test in the UK
The Oncotype DX test is available through the National Health Service (NHS) across the UK. The National Institute for Health and Care Excellence (NICE) has issued guidance recommending the use of Oncotype DX to guide adjuvant chemotherapy decisions in early breast cancer. This guidance supports its use for specific patient groups, including postmenopausal women and men with ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.
Access to the test can vary between different NHS trusts and Cancer Alliances, as specific criteria must be met for NHS funding. For individuals who do not meet NHS criteria or prefer private healthcare, the Oncotype DX test can be accessed privately. The approximate cost is around £3,000 privately in the UK. Your treatment team can order the test and discuss results, regardless of the access pathway.