Company Also Highlights FDA Clearance of MammaPrint in FFPE
IRVINE, CA and AMSTERDAM, THE NETHERLANDS – Agendia, a leading molecular diagnostics company that develops and markets genomic diagnostic products, 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.
Resources for further reference
- MammaPrint FFPE receives FDA 510(k) clearance press release
- RASTER prospective outcome study and press release
- Independent comparison validates molecular subtyping (includes video)
- MammaPrint valid up to 25 years press release
Agendia is a privately held, leading molecular diagnostics company that develops and markets FFPE-based genomic diagnostic products, which help support physicians with their complex treatment decisions. Agendia’s breast cancer suite was developed using an unbiased gene selection by analyzing the complete human genome. Our offerings include the FDA-cleared MammaPrint FFPE as well as BluePrint, a molecular subtyping assay that provides deeper insight leading to more clinically actionable biology, and TargetPrint®, an ER/PR/HER2 expression assay. MammaPrint is the only breast cancer recurrence assay supported by peer-reviewed, published, prospective outcome data. These tests can help physicians assess a patient’s individual risk for metastasis – that is, which patients are more sensitive to chemo, hormonal, or combination therapy, and which patients may not require these treatments and which patients may be treated with other, less arduous and costly methods.
In addition, Agendia has a pipeline of other genomic products in development. The company collaborates with pharmaceutical companies, leading cancer centers and academic groups to develop companion diagnostic tests in the area of oncology. It is also a critical partner in the ISPY-2 and the MINDACT trials. For more information, visit www.agendia.com.
Liz Dowling (Medical & Consumer Media)
Dowling & Dennis Public Relations
SPJ Financiële & Corporate Communicatie
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Matt Clawson (Financial Media)