Markedshøring Oncotype DX

Description

Region Zealand is assisting the Danish Health Technology Council in conducting a market consultation about the existence of any CE marked non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), early-stage (I-IIIa) invasive breast cancer. The test provides two pieces of information: 1. the recurrence risk and 2. the benefit of adding chemotherapy in order to reduce the risk. The test analyses the expression of 21 genes in breast tumour tissue based on RT-PCR. It does not require additional tumour material beyond the surgically excised tissue. This is the case because a company has requested the Danish Health Technology Council to assess their non-invasive prognostic test to guide adjuvant chemotherapy treatment decisions for individuals with HR+, HER2-, I-IIIa invasive breast cancer.