Result card

  • TEC5: Why FEMTELLE®, MammaPrint®, and Oncotype DX™ are used?
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Why FEMTELLE®, MammaPrint®, and Oncotype DX™ are used?

Authors: Pseudo169 Pseudo169, Pseudo90 Pseudo90, Pseudo154 Pseudo154, Pseudo98 Pseudo98

Internal reviewers: Patricia Harrington, Michelle O'Neill, Leonor Varela

The manufacturers’ websites as well as the results from the basic search were used to develop this assessment element.

The intended use of the three tests (FEMTELLE, MammaPrint, and Oncotype DX) is prognostic (likelihood of breast cancer recurrence) and the results need to be considered together with all the other clinical and pathological factors.

FEMTELLE assesses the likelihood of breast cancer recurrence in women with newly diagnosed, lymph node-negative (LN-) breast cancer. FEMTELLE quantitatively determines the uPA  and PAI-1 levels in tumour tissue extracts, allowing the identification of patients with a high (uPA and/or PAI-1 high) or low (uPA and PAI-1 low) risk of recurrence {7}. The timeframe within which such risk recurrence applies is not clearly stated.

MammaPrint has different indications for Europe and the USA:

  • In Europe, it is intended as a prognostic test for women of all ages, with LN- and LN+ breast cancer (up to 3 nodes positive) with a tumour size ≤ 5.0 cm {8}.
  • In the USA, it is intended as a prognostic test for women ≤ 61 years with primary invasive, oestrogen receptor-positive (ER+), or oestrogen receptor-negative (ER-) LN- breast cancer {9}{Appendix COL-2}. It assesses a patient’s risk for distant metastasis (up to 10 years for patients less than 61 years old, up to 5 years for patients 61 years). The test is indicated for breast cancer patients with Stage I or Stage II disease, with a tumour size of ≤ 5.0 cm and LN-.

Oncotype DX is intended to predict the likelihood of recurrence in women of all ages with newly diagnosed Stage I or II, ER+LN- breast cancer treated with tamoxifen {8}. The test assigns the breast cancer a recurrence score. The test also looks at the expression of hormone receptor genes, both the ER and progesterone receptor (PR), and can provide an indication of how responsive the cancer is likely to be to hormonal therapy {8}.

Pseudo169 P et al. Result Card TEC5 In: Pseudo169 P et al. Description and technical characteristics of technology In: Jefferson T, Vicari N, Raatz H [eds.]. Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX ) [Core HTA], Agenzia nationale per i servizi sanitari regionali (, Italy ; 2013. [cited 2 December 2022]. Available from: