Agendia’s Mammaprint® breast prognostic test wins innovation award
Following my article on latest prognostic tests for breast cancer, Dutch firm Agendia BV are leading the field again! Their Mammaprint® test is the first microarray to gain FDA approval and now they have won a prestigious award for innovation in the field of breast cancer.
The 2007 Frost & SullivanEuropean Product Innovation Award in the field of biomarker-based breast cancer diagnostics is presented to Netherlands-based Agendia BV, for its new method of translating a breast cancer prognosis microarray signature into a high-throughput diagnostic test called MammaPrint.
The Frost & Sullivan Award for Product Innovation is presented each year to the company that has demonstrated excellence in new products and technologies within its industry. The recipient company has shown innovation by launching a broad line of emerging products and technologies.
Agendia’s product offering employs a robust custom-made microarray that efficiently analyses gene expression profiles of 70 known cancer genes and determines the probability of breast cancer recurring within five to ten years after initial determination.
“The MammaPrint® breast cancer recurrence test has been proven to outperform clinical parameters in predicting distant metastasis in breast cancer patients,” notes Frost & SullivanResearch Analyst Sandhya Kamath. “Based on a platform of sophisticated microarray expression profiling and proprietary algorithms to interpret gene signatures, MammaPrint® categorizes breast cancer patients based on prognosis.”
The MammaPrint® test measures the activity levels of each of the 70 genes in a sample (surgically excised breast tumor) and then, based on a specific algorithm, classifies breast cancer patients into different groups based on their risk for developing distant metastasis. These results, in conjunction with other clinical information and laboratory tests, assists physicians in identifying the most suitable therapy and provide patients with opportunities for better treatment.
Agendia was granted the ISO 17025 accreditation and CE registration for the MammaPrint®in 2005. In February 2007, Agendia became the first company to receive a 510K clearance from the US FDA for it’s MammaPrint®breast cancer prognosis test on fresh or fresh-frozen tumour tissue under the newly defined in vitro diagnostics multivariate index assay (IVDMIA) regulations.
“In June 2007, Agendia received a second clearance from the FDA for its MammaPrint®sampling and room temperature shipping procedure, using a RNA preserving solution (RNARetain®*),”adds Ms. Kamath. “The use of RNARetain in combination with MammaPrint® is even simpler than the commonly used formalin fixation and paraffin embedding (FFPE) method and is specifically designed and validated to preserve RNA integrity.”
“Agendia is truly one of the most promising companies endeavoring to translate gene expression analysis into clinical tests,”concludes Ms. Kamath. “In addition to MammaPrint®, the company has two more innovative diagnostic tests in the market: the CupPrint, a test that determines the tissue type of a tumor of unknown origin, and the DiscoverPrint, which predicts responders and non-responders to experimental new cancer drugs by analyzing RNA from tumors treated with these drugs with DNA microarrays.”
Agendia are certainly a company to watch!
Elaine WarburtonBSc RN ACA www.geneticsandhealth.com
