Genetic Technologies Receives CE Mark Approval for BREVAGen™
Melbourne, Australia: Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE)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 recognise 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. This is nearly double the incidence rate in the U.S. of just over 180,000 cases per year (cited electronically at https://globocan.iarc.fr/). Approximately 80% of women who develop breast cancer develop non-familial or sporadic breast cancer, that is, they have little or no family history of the disease.
“The achievement of CE Mark for our flagship BREVAGen™ product is a major milestone for the Company,” stated Dr. Paul MacLeman, CEO of Genetic Technologies. “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. The test was launched in June 2011 in select regions in the U.S. and is currently available in 48 U.S. States.
CE Marking Conformité Européenne, meaning European conformity, is a mandatory conformity mark for certain products placed on market in the European Economic Area including medical devices and IVD tests.
CE Marking ensures that the manufacturer’s product conforms to the essential requirements of the relevant European health, safety and environmental protection legislation. IVD tests, in accordance with the EU directive 98/79/EC for IVDD, must be safe and function as per the manufacturer’s intended purpose. BREVAGen’s™ CE Marking certification was conducted by MT Promedt Consulting GmbH, a globally recognised European Authorized Representative with offices in Germany and the U.S.

