Result card

  • TEC13: What kind of qualification, training and quality assurance are needed for the use of FEMTELLE®, MammaPrint®, and Oncotype DX™?
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What kind of qualification, training and quality assurance are needed for the use of FEMTELLE®, MammaPrint®, and Oncotype DX™?

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

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

Direct questions to the manufacturers were used to develop this assessment element.

As the three tests are provided or recommended as testing services (to be performed exclusively by the manufacturer’s laboratories or, in the case of FEMTELLE, by other laboratories as recommended by the manufacturer) no special staff, training or other human resources are needed within the centres to perform the tests. Specimen preparation is the only key issue and needs to be performed by the pathologist, following specific instructions provided by the manufacturer. In particular, FEMTELLE requires fresh/fresh-frozen tumour tissue while MammaPrint can be performed using either fresh/fresh-frozen tumour samples or FFPE samples, and Oncotype DX functions with FFPE samples. For this reason, qualification, training and quality assurance related to the sample preparation strongly depend on the specific local context and on familiarity with the various sample preparation techniques.

Laboratories that want to establish FEMTELLE testing at their site need specific training. For this purpose the technicians involved receive detailed technical training at selected laboratories. The training is usually planned for 3 days. Participants are trained on the whole technical procedure (tissue homogenisation, protein extraction, ELISA testing, total protein determination and calculation of the results). American Diagnostica usually supports the new attendees {Appendix COL-2}.

For Oncotype DX only the manufacturer (Genomic Health) has established guidelines on how to select slides (to ensure that the slide contains sufficient tumour material and that the diagnosis is correct). No further training is needed for a local pathologist. At Genomic Health, all slides are reviewed by board-certified pathologists to ensure the correct diagnosis and if necessary they perform micro-dissection to select material for analysis {Appendix COL-2}.

Pseudo169 P et al. Result Card TEC13 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: