Agendia Reports More Than 20,000 MammaPrint Breast Cancer Recurrence Results - Gilde Healthcare

Agendia Reports More Than 20,000 MammaPrint Breast Cancer Recurrence Results

May 2, 2013

Revenues Continue to Ramp in 2013

IRVINE, CA – Agendia, a world leader in molecular cancer diagnostics, today announced that it has reported more than 20,000 MammaPrint breast cancer results, including approximately 6,000 in 2012 alone.  The MammaPrint test analyzes 70 key genes and accurately determines which patients are at low risk of breast cancer recurrence and can therefore safely choose not to undergo chemotherapy.

Case volume grew by more than 140 percent in 2012 and a steep growth trajectory has continued into the first quarter of 2013, noted David Macdonald, Agendia’s Chief Executive Officer.

“In addition to this phenomenal growth in a changing healthcare market, Agendia has extended its legacy of  leadership in both the clinical and research arenas. The precedent-setting peer-reviewed RASTER publication is the only 5-year outcome study in which MammaPrint was incorporated prospectively into the physician-patient treatment decision. No other gene signature has demonstrated such conclusive effectiveness in accurately guiding the correct decision for patient care. This study has definitely provided a spark in the marketplace,” Macdonald said. The RASTER study shows that MammaPrint accurately identifies half of breast cancer patients who can safely forgo chemotherapy with excellent outcome. “That data has given physicians and oncologists throughout the world confidence in the ability of MammaPrint to determine risk, and to guide therapeutic choices.”

The success of MammaPrint has also driven growth in the other genomic diagnostic products that make up Agendia’s Symphony™ suite of tests, including BluePrint® and TargetPrint®. More than 85 percent of Agendia customers using MammaPrint also order BluePrint® and TargetPrint® to obtain vital genomic information used in treatment decisions, added Macdonald.

About MammaPrint

MammaPrint is the first and only FDA-cleared IVDMIA breast cancer recurrence assay. The unique 70-gene signature of MammaPrint provides clinicians with a second generation tool that stratifies a much broader range of early stage breast cancer patients into either a low risk vs. high risk of distant cancer recurrence following surgery. This test goes well beyond the first generation 21-gene test by accurately providing guidance for patients who have the more challenging estrogen receptor low or negative and Her-2 positive patients. Furthermore, MammaPrint evaluates all of the critical molecular pathways involved in the formation of potentially lethal metastasis as opposed the more limited first generation tests. It is equally accurate in formalin fixed-parrafin embedded tissues as it was originally in fresh and frozen tissue. This provides equal access for breast surgeons as well as medical oncologists to offer this critical analysis to patients.

About Agendia

Agendia is a leading molecular diagnostic company that develops and markets FFPE-based genomic diagnostic products. Agendia’s breast cancer Symphony™ suite was developed using unbiased gene selection, analyzing the complete human genome, ensuring 100% definitive results for cancer patients. Together, these tests help physicians determine a patient’s individual risk for metastasis, which patients will benefit from chemo, hormonal, or combination therapy, and which patients do not require these treatments and can instead be treated with other less arduous and less costly methods.

In addition to the Symphony suite of tests, Agendia has a rich pipeline of 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 and is a critical partner in the ISPY-2 and MINDACT trials.  For more information, please visit www.agendia.com.

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