The results of the FEMTELLE uPA/PAI-1 assay are reported as absolute protein concentrations of uPA and PAI-1 in the patient’s tumour tissue. The uPA and PAI-1 values refer to the respective total protein concentrations {16}. The results help to identify those node-negative patients who have a low risk of disease recurrence and those patients who have a high risk of disease recurrence after surgery.

Cut off values are:

• uPA = 3 ng/mg total protein
• PAI-1 = 14 ng/mg total protein

Patients with low uPA and low PAI-1 values (below the cut off) are predicted to have a low risk of disease recurrence. The risk value, intended as percentage of recurrence within a timeframe without further adjuvant therapy, is not stated. Patients with high uPA and/or high PAI-1 values (above the cut off) are predicted to have an increased risk of disease recurrence {20}. The risk value, intended as percentage of recurrence within a timeframe without further adjuvant therapy, is not stated.

The results of the MammaPrint test are used for risk-group assignment on the basis of a dichotomised value only (i.e., high or low risk). A tumour is defined as having a low-risk gene signature if the cosine correlation coefficient for the expression of the 70-gene profile in that tumour with the previously established classifier is above 0.4, which is the cut-off point used in the original study by van’t Veer {9} {21}. A “low risk” result means that a patient has a 10% chance that her cancer will recur within 10 years without additional adjuvant treatment, either hormonal therapy or chemotherapy. A “high risk” result means that a patient has a 29% chance that her cancer will recur within 10 years without any additional adjuvant treatment, either hormonal therapy or chemotherapy {9}.

The results of the Oncotype DX are used to calculate the 10-year risk of distant recurrence as a continuous function of the RS. Three risk groups have been defined: low risk (RS ≤17), intermediate risk (18 ≤RS ≤30), and high risk (RS ≥ 31) {9}.