GTG gets CE Mark for breast cancer test

Shares in Genetic Technologies (ASX:GTG) climbed 9% as the company revealed it had achieved CE Mark approval for BREVAGen, its breast cancer risk assessment tool.

The company has received the certification from its designated European Authorised Representative, Germany's Promedt Consulting, paving the way for BREVAGen sales in the EU.

Genetic Technologies has revealed plans to concentrate its initial European launch efforts on the key French and German markets.

CEO Dr Paul MacLeman called the receipt of a CE Mark for the test “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,” he said.

Breast cancer is the most common form of cancer in European women, with recorded cases in the EU reaching over 330,000 in 2008.

BREVAGen is a genetic test that detects certain DNA variations associated with increased risk of breast cancer.

Genetic Technologies started rolling out the test in the US in June 2011, and has steadily been gaining the approvals to launch in all 50 US states. The company received CLIA certification for its Victorian lab in February, and most recently got the nod to provide the test in the important Californian market.

BREVAGen is now available in 48 US states. Genetic Technologies conducts the testing through its US subsidiary, Phenogen Sciences.

Genetic Technologies (ASX:GTG) shares opened Wednesday's trading up 9.09% at $0.120, and were trading at the same price as of around 2:30pm.