Result card

  • CUR21: Which approval status has Genetic Test in other countries, or international authorities?
Prognostic tests for breast cancer recurrence (uPA/PAI-1 [FEMTELLE], MammaPrint, Oncotype DX )
A0020
English
Guidance

Which approval status has Genetic Test in other countries, or international authorities?

Authors: Sarah Baggaley, Massimo Gion

Internal reviewers: Luciana Ballini, Aurora Llanos, Antonio Migliore, Claudia Wild

The information used for this section was from the manufacturer’s websites and web-based searches.

The FEMTELLE test is manufactured by American Diagnostica Inc. (member of Sekisui Group) and has received the CE mark for use in Europe {3}.

MammaPrint is manufactured by Agendia and has received the CE mark for use in Europe. It is also approved for use by the US Food and Drug Administration (FDA) {4}.

The Oncotype DX assay is manufactured by Genomic Health and has received the CE mark for use in Europe. The assay is offered as a laboratory developed test and therefore, does not require FDA approval at this time {5}.

Please refer to the TEC domain for further details.

Important
Completely
Baggaley S, Gion M Result Card CUR21 In: Baggaley S, Gion M Health Problem and Current Use of the 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 (age.na.s), Italy ; 2013. [cited 7 February 2023]. Available from: http://corehta.info/ViewCover.aspx?id=113

References