The lowdown: Despite much hype about the potential use of gene-expression analysis in the diagnosis and classification of cancer, the concept has been slow to be translated into clinical practice. There are masses of microarray data relating to cancer available in the public domain, but it is challenging to validate these data and to standardize and compare data sets from different laboratories that have used various technologies. Now, the approval by the FDA of the first in vitro diagnostic multivariate assay (IVDMIA) for marketing in the United States is a significant advance for the field, and a proof-of-concept for more personalized medicine.
MammaPrint is a gene-expression-based prognostic test developed by Agendia, a small biotechnology company in the Netherlands. Agendia collated genetic information from a large group of women with breast cancer and compared the genetic profiles of their tumours to generate a signature of genes with altered expression that can be associated with prognosis. Based on the signatures they identified, they developed the MammaPrint, a microarray that is used to measure the levels of expression of 70 identified risk genes and then calculate a score that is predictive of whether the initial tumour is likely to metastasize. This then enables doctors to gauge the risk of recurrence within 5 to 10 years of the initial tumour occurring and make treatment decisions accordingly.
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