Answer:
MammaPrint is a gene expression profiling system to assess the risk of cancer recurrence in patients with breast cancer. The system is based on the expression of 70 of the most informative genes in the tumor, quantified simultaneously to ensure a high degree of accuracy in determining the risk of breast cancer recurrence.  MammaPrint result is indicated for use by physicians as a prognostic marker in combination with other clinical information and laboratory tests. MammaPrint is also the first in vitro diagnostic multivariate index assay (IVDMIA) to acquire market clearance from the FDA.

Answer:
Getting as much information as possible about individual risk can help to prevent unnecessary harmful therapies and supports the selection of optimal tailored treatment when really needed.  MammaPrint test results are secured by an unmatched level of substantial validation and diagnostic excellence, namely it has been cleared by the U.S.  Food and Drug Administration (FDA), the strictest organization for patient’s safety in the world.
    
MammaPrint is a test that analyzes the genetic makeup of the tumor itself, looking at the activity of 70 informative genes.  This information indicates if a tumor is likely to spread or not, providing a clearer picture of a patient’s risk (low or high) for breast cancer recurrence within the next 10 years.  Only this result can provide valuable insight for physicians to personalize a patient’s medical care – helping them in planning appropriate follow-up for a patient.

Answer:
MammaPrint is appropriate for patients 61 years and younger with lymph node-negative breast cancer (stage I or II), tumor size < 5 cm, regardless of ER status or pretreatment.

Answer:
A 3mm biopsy of the surgically removed breast tumor tissue is required for the test.

Answer:
Federal law restricts this device to being ordered by a physician only. However, a growing group of physicians are ordering the test at the specific request of the patient

Answer:
The analysis takes place in the Agendia laboratories in Amsterdam.

Answer:
The physician collects the tissue samples during or within one hour after breast cancer surgery. Using the MammaPrint sampling kit and RNARetain transport solution, the sample is prepared for shipment via FedEx in a prepaid, pre-addressed package.

Answer:
Test results are sent back to physicians about 10 working days after Agendia has received the sample.

Answer:
Agendia is the exclusive gene expression profiling partner in the MIcroarray for Node negative Disease may Avoid Chemotherapy Trial (MINDACT), the largest worldwide microarray-based clinical trial to date.  This multicenter, prospective, randomized Phase 3 trial involves nearly 6,000 European breast cancer patients.  Recruitment began in 2007.

The primary objective of MINDACT is to expand the MammaPrint indication through identification and validation of novel gene expression signatures that can predict clinical response to therapies used such as chemotherapy and endocrine (hormonal) therapy.

In addition, MammaPrint also is being introduced in several countries through additional clinical validation studies.

Answer:
MammaPrint has a high degree of accuracy, predicting metastasis-free survival at 5 years at 95% for low risk and 78% for high risk in independent studies with over 200 patients (Publications). It has also been FDA cleared for safety and efficacy, validating its performance in terms of repoducibility and accuracy.

Answer:
Yes, but if it has been stored at minus 70 degrees Celsius.

Answer:
We are actively reaching out to payers across the country to secure reimbursement for MammaPrint. As the test becomes more widely used by physicians in the coming months, we anticipate widespread adoption of MammaPrint as a covered test by private insurers.