The US Food and Drug Administration (FDA) has approved the first of a new kind of genetic test that predicts the likelihood of breast cancer returning up to ten years after it has been diagnosed for the first time. The news was released on the FDA website and in press conferences.
The MammaPrint test, developed by Agendia, a Dutch laboratory based in Amsterdam, profiles genetic activity and has been on the market since 2005. The prognostic test uses state of the art molecular technology to work out the odds of a Stage I or Stage II breast cancer’s return or metastasis (spread to other parts of the body).
Based on a technology known as in vitro diagnostic multivariate index assay (IVDMIA), the test measures the genetic activity of biological specimens such as excised tumours. It does this by measuring 70 different markers that pick up which genes are active and which genes are suppressed. The genetic profile of active and suppressed genes has been shown to be a reliable predictor of the odds of a tumour spreading or returning.
An algorithm converts the 70 different gene markers into a prognostic index of recurrence or metastasis to help doctors and patients make decisions about longer term treatment and follow up.
Commissioner of Food and Drugs, Dr Andrew von Eschenbach, said that “Clearance of the MammaPrint test marks a step forward in the initiative to bring molecular-based medicine into current practice.”
The FDA will be holding a meeting tomorrow to discuss its regulatory approach to this type of laboratory test.
Director of the Office of In Vitro Diagnostic Device Evaluation, Dr Steven Gutman said, “There have been rapid advances in microarrays and other pioneering diagnostics, and a corresponding increase in the use and impact of these complex tests.” This has prompted the FDA to look into the risks as well as benefits of such laboratory devices. He said that this clearance “takes into account the development of these innovative technologies and ensures public health by carefully evaluating their performance.”
Agendia supplied the FDA with the results of a study on 302 patients from 5 European clinics that confirmed the usefulness of the test. The data showed it was able reliably to predict the time to metastasis in women under 61 years of age who had Stage I and Stage II breast cancer, and whose tumours were 5 cm or smaller and had not reached the lymph nodes nearby.
This year it is estimated that 178,480 American women will be diagnosed with invasive breast cancer for the first time, of which over 40,000 are expected to die from it (American Cancer Society).
Food and Drug Administration (FDA).
Written by: Catharine Paddock
Writer: Medical News Today