Result card

  • LEG12: Have Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) national/EU level authorisation?
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Have Genetic Tests (uPA/PAI-1 ELISA/ Oncotype DX/ MammaPrint) national/EU level authorisation?

Authors: Marina Casini, Emanuela Midolo, Marco Marchetti

Internal reviewers: Judite Neves, Ana Bação, Vesna Kovač

The domain methodology used for this question has been collection, selection and analysis of European norms and sentences.

Our research has found that in Europe only the MammaPrint test has been commercially available since July 2005 when the Dutch Healthcare Inspectorate approved it as a medical device presenting low risks. The US Food and Drug Administration (FDA) also approved it. The references substantiating this are contained in the bibliography {27}. The uPA/PAI-1 test is recommended in the guidelines of the American Society of Clinical Oncology (ASCO) and the guidelines of the German Association of Gyneclogical Oncology (AGO). Oncotype DX is approved by the US FDA and has been commercially available since 2004. It is also recommended by the ASCO guidelines. The Oncotype DX collection kit received an EC stamp of approval and may be distributed in every country of the European Economic Area. Furthermore, regarding authorisation of medicinal products for human use one may refer to the Guidelines 2010 / C 82/01 of the European Commission on an application for a permit for a clinical trial of a medicinal product for human use {28}. These guidelines are addressed to the competent authorities and also cover the notification of substantial changes and the declaration of the end of the trial. The legal framework on the subject in question must also take into account of the ruling of the Court of Justice of the European Union (fourth section) 03.07.2002, in Case T-179/00, A. Menarini vs. Commission of European Communities{29}.We call attention to the Sentence of the European Court of Justice of 3 July 2002 T-179/00. We report what the producers of this kind of test affirmed: “The Genomic Health Clinical Laboratory is regularly inspected by the College of American Pathologists and federal and state agencies. Audits include a complete review of the Oncotype DX assays, including a thorough assessment of assay validation reports, the procedure manual, and the quality control and quality assurance processes described above. In nine on-site audits since its opening in 2004, the Genomic Health Clinical Laboratory has never received a deficiency, and all requests to add new assays to our test menu have been granted”.

Casini M et al. Result Card LEG12 In: Casini M et al. Legal aspects 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: