Updated on 8 August 2012
New hope for breast cancer in EU: BREVAGen gets CE Mark approval
Singapore: Genetic Technologies announced today that it has received European CE Mark approval for BREVAGen, the company's breast cancer risk test. The CE Mark designation will allow BREVAGen to be sold in the EU and other countries that recognize the CE Mark. The initial commercial focus will be in the key markets of France and Germany.
Breast cancer is the most common form of cancer in European women. In 2008, annual breast cancer incidence in the European Union (EU-27) was over 330,000. Approximately 80 percent of women who develop breast cancer suffer from non-familial or sporadic breast cancer, that is, they have little or no family history of the disease.
Dr Paul MacLeman, CEO, Genetic Technologies, said that, "The achievement of CE Mark for our flagship BREVAGen product is a major milestone for the company. Given the significant incidence rate of breast cancer in the EU, there is a critical need for enhanced risk assessment tools, leading to improved preventative management and surveillance."
BREVAGen uses a novel approach to non-familial breast cancer risk assessment, combining validated breast cancer susceptibility genetic markers with a patient's individual clinical risk factors to yield an integrated, more accurate risk score.