A cutting-edge prognostic tool called MammaPrint, developed by Agendia, a laboratory located in The Netherlands, uses molecular technology to predict whether breast cancer will metastasize, helping clinicians make more accurate management decisions for their patients.
A cutting-edge prognostic tool called MammaPrint, developed by Agendia, a laboratory located in The Netherlands, uses molecular technology to predict whether breast cancer will metastasize, helping clinicians make more accurate management decisions for their patients.
"Clearance of MammaPrint marks a step forward in the initiative to bring molecular-based medicine into current practice," FDA commissioner Andrew C. von Eschenbach, MD, noted in a public statement following MammaPrint's FDA approval.
Cancer Care & Economics (CC&E) recently spoke with Ren Bernards, PHD, chief scientific officer of the team that developed this significant new test.
CC&E: Microarray analysis in itself is not new-what scientific application was MammaPrint created to address? What makes it a first-of-its-kind test?
DR. BERNARDS: Agendia decided to use microarray technology instead of other techniques like reverse transcription polymerase chain reaction (RT-PCR) because it allows the whole genome to be analyzed at once, identifying the most relevant genes to develop a signature. We succeeded in finding the set of genes that was proven to be significant in the prognosis of breast cancer tumor recurrence.
CC&E: What molecular activity does MammaPrint identify as a prognostic factor?
DR. BERNARDS: The 70 genes analyzed in the MammaPrint breast cancer test are genes involved in cell cycle, invasion, metastasis, and angiogenesis.
CC&E: How does MammaPrint fit into the clinical practice of breast cancer; in other words, how does a community doctor utilize this technology?
DR. BERNARDS: Traditionally, the physicians who utilize the MammaPrint breast cancer test are oncologists, breast surgeons, and pathologists. The value of the test to physicians is in its results. MammaPrint provides information regarding each individual patient's risk of breast cancer tumor recurrence, which can then be used by physicians to more effectively tailor treatment regimens, potentially increasing the quality of life of many patients by avoiding the use of unnecessary, harmful therapies.
CC&E: Does the information gained from MammaPrint enable a clinician to better "target" the choice of therapy?
DR. BERNARDS: MammaPrint 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.
This result can provide valuable insight for physicians to personalize a patient's medical care, helping them plan appropriate follow-up based on their risk of tumor recurrence.
CC&E: What are the costs of this test, and to your knowledge is it something that private payers will reimburse for?
DR. BERNARDS: The cost of the test is $4,200 (US dollars). Now that MammaPrint will be more widely available in the United States, we are actively reaching out to payers across the country and anticipate widespread adoption as a covered test by private insurers.