A published study has shown that Agendia's MammaPrint breast cancer (BC) test can dramatically reduce the number of women who need to undergo chemotherapy to treat the disease.
The prospective, outcome-based study of 427 BC patients showed the genomic test, which analyses 70 key genes, accurately determines which patients are at low risk of BC recurrence and can therefore safely choose not to undergo chemotherapy. The results of the peer-reviewed study, called MicroarRAy PrognoSTics in Breast CancER (RASTER), conducted in 16 community-based clinics in the Netherlands, were published online by The International Journal of Cancer. The RASTER study is considered unique by its co-authors because it is the first and only study to prospectively evaluate the performance of a genomic BC test by using outcome data.
Of the 219 patients in the five-year study who were determined to be low-risk based on the MammaPrint test, 85 per cent chose not to have chemotherapy. Of those patients, 97 per cent were disease free after five years. Of the 208 patients who were determined to be high-risk, 81 per cent chose chemotherapy and 91 per cent were disease free after five years.
The study also showed that MammaPrint identified 30 per cent more patients as low-risk than traditional clinical parameters such as; tumour size, grade, patient age and lymph node status, which are often used in the US to determine risk of recurrence. MammaPrint is a 70-gene, BC assay performed on both fresh and FFPE tumour tissue, developed by Agendia.
Prof S C Linn, the principal investigator, stated that MammaPrint correctly stratified patients into low-risk and high risk categories based on prognosis of a recurrence of the disease.
MammaPrint is believed to be the first and only FDA-cleared IVDMIA BC recurrence assay. The 70-gene signature of MammaPrint provides the unprecedented ability to identify which early-stage BC patients are at risk of distant recurrence following surgery, independent of oestrogen-receptor status and any prior treatment. Unlike previous-generation genomic tests, MammaPrint evaluates all of the critical molecular pathways involved in the BC metastatic cascade. It analyses 70 critical genes that comprise a definitive gene expression signature and stratifies patients into two distinct groups: low-risk or high-risk of distant recurrence. With MammaPrint, there are no intermediate results.