Agendia Announces Recommendation of MammaPrint in Germany’s AGO Guidelines
News Apr 16, 2015
Agendia has announced at the St. Gallen International Breast Cancer Conference that new guidelines of the Arbeitsgemeinschaft Gynäkologische Onkologie (AGO) recommend the MammaPrint® 70-gene breast cancer recurrence assay in Germany’s 2015 guidelines for early-stage invasive breast cancer.
"We are extremely pleased that this expert panel has recognized MammaPrint and the substantial body of clinical evidence supporting it," said Jan Egberts, MD, Agendia’s Chief Executive Officer. "MammaPrint is the only breast cancer recurrence assay recommended in the AGO guidelines that is supported by peer-reviewed, prospective five-year outcome data to determine which patients are at low risk of breast cancer recurrence and can therefore safely forego chemotherapy.”
At the St. Gallen conference, Agendia sponsored an evening symposia presented by Fatima Cardoso, MD, PhD that highlighted the MINDACT Trial and the U.S. Food & Drug Administration’s (FDA) recent decision to grant MammaPrint its sixth FDA 510(k) clearance. The most recent clearance is for use in formalin-fixed paraffin embedded (FFPE) tissue samples.
MammaPrint provides an unambiguous binary Low Risk or High Risk recurrence result. It is part of Agendia’s suite of breast cancer assays that also includes the BluePrint® 80-gene molecular subtyping assay and TargetPrint®, a gene-expression assay. BluePrint provides additional therapy-predictive information, identifying the functional molecular subtype of breast cancer and the associated tumor response to neoadjuvant therapy. Like MammaPrint and TargetPrint, BluePrint is performed on FFPE. It is the most widely available test that uncovers the functional molecular subtype of a woman’s breast cancer.
“Agendia’s suite of breast cancer recurrence assays fundamentally changes the conversation at the critical point where treatment decisions are being made,” said Egberts. “While MammaPrint test results eliminate the ambiguity of the intermediate result seen in up to 39% of other tests, functional molecular subtyping by BluePrint provides greater insight into the tumor biology that just isn’t available from most of the other breast cancer recurrence assays on the market.”
MammaPrint is available worldwide and has substantial insurance coverage, including Medicare, regional, and national insurers, encompassing an estimated 200 million lives in the U.S.
The 14th St. Gallen International Breast Cancer Conference took place in Vienna, Austria, March 18-21, 2015.
Neuroblastoma Biomarker Research Advances TreatmentNews
Neuroblastoma, a childhood cancer, is treatable in less than half of aggressive cases, but new RNA biomarkers may help identify high-risk patients faster and lead to better prognosis.READ MORE
Test For Designer Drugs Could Help Treat Overdose PatientsNews
Medical professionals are scrambling to meet the growing demand for emergency room treatment, but they’re hampered by the lack of a quick and easy test to screen patients for “designer” drugs. Chemists have now developed such a test and are refining it with the hope that hospitals could eventually use it to choose the appropriate treatment.READ MORE
Cancer Comes Back All 'Jacked Up' on Stem CellsNews
Recent work increasingly shows that tumors are not static - the populations of cells that make up a tumor evolve over time in response to treatment, often in ways that lead to treatment immunity. Instead of being defined by a snapshot, tumors are more like a movie. This means that a tumor that recurs after treatment may be much different than the tumor originally seen in a biopsy.READ MORE