Result card

  • CUR11: How much is Genetic Test being used?
English

How much is Genetic Test being used?

Authors: Sarah Baggaley, Massimo Gion

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

The information used for this section was from guidelines, manufacturer’s websites and, surveys or questions sent to European healthcare agencies, clinicians and manufacturers.

According to the manufacturer, MammaPrint is currently marketed in all European countries and the test is most widely used in Spain, the Netherlands and Italy {Appendix COL-1}. Results from the survey of healthcare agencies suggest the test is also used in Germany, Slovenia and the UK {Appendix COL-3}.

Results from the manufacturer survey reported that the FEMTELLE uPA/PAI-1test is marketed in Germany, Spain, Slovenia, France and Italy and is most widely used in France and Germany. It is estimated that 7000 patients in Germany and 2000 patients in France are routinely tested each year {Appendix COL-1}. Results from the survey of healthcare agencies reported that the FEMTELLE uPA/PAI-1test is used in Germany and Slovenia and not used in Latvia, Norway, Spain and the UK {Appendix COL-3}.

Results from the manufacturer survey reported that the Oncotype DX test is marketed in Germany, UK, France, Spain, Greece, Hungary and Ireland. The test is most widely used in UK, Germany, Spain and Ireland {Appendix COL-1}. Results from the survey of healthcare agencies reported that the Oncotype DX test is used in Germany, Ireland, Italy, Slovenia, Spain and the UK {Appendix COL-3}.

The survey from clinicians suggested that all three tests are in use in Europe and that Oncotype DX is the most widely used. However, only seven clinicians responded to the survey and this low response rate may be at least in part due to the low use of the tests in European countries {Appendix COL-2}.

The Oncotype DX assay is included in three clinical guidelines from the National Comprehensive Cancer Network (NCCN) {24}, the American Society of Clinical Oncology (ASCO) {25}, and the St Gallen Consensus guidelines {26}. All three guidelines have included the Oncotype DX assay as a test to predict the patient benefit from chemotherapy.

The FEMTELLE uPA/PAI-1 test has been recommended in clinical guidelines from the ASCO {25}, the German Working Group of Gynecological Oncology (AGO) {27} and the German Breast Cancer Society for therapy decisions in node-negative breast cancer {28}. The National Academy of Clinical Biochemistry laboratory medicine practice guidelines include the FEMTELLE uPA/PAI-1 test for use of tumour markers in breast cancer {29}.

The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group found insufficient evidence to recommend for or against the use of tumour gene expression profiles (Oncotype DX and MammaPrint). It considered that until more evidence was available the use of these prognostic tests should be decided by the clinician on a case by case basis {30}.

From the evidence and surveys it is unclear how much the prognostic tests are being used in Europe. It is likely that the low survey response rate is likely at least in part due to the low use of the tests in Europe although the recommendations for the use of MammaPrint in clinical guidelines in Germany suggest that the uptake of the MammaPrint test in Germany may be higher than the evidence and surveys indicate. The use of the Oncotype DX and MammaPrint prognostic tests is recommended in a number of clinical guidelines in the USA and, therefore, it is likely that the use of these prognostic tests is higher in the USA than in Europe.

Important
Partially
Baggaley S, Gion M Result Card CUR11 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