Genetic Technologies' Australian laboratory has tested first BREVAGen clinical sample from a US patient, following the receipt of certification under the US Clinical Laboratories Improvements Amendments (CLIA) (42 U.S.C. 263a).
The BREVAGen breast cancer risk stratification test is a genetic test panel that examines a patient’s buccal (cheek) swab to detect the absence or presence of certain common genetic variations (SNPs) associated with an increased risk for developing breast cancer.
The sample was received by Phenogen Sciences, Genetic Technologies’ new North American subsidiary, where the sample was bar-coded and entered into the Laboratory Information Management System.
The test helps physicians to assess and aggregate breast cancer risk from these genetic markers, together with factors from a standard clinical assessment based on a patient’s family and personal history.
These factors combine to provide information of an individual woman’s risk of developing breast cancer.
The BREVAGen test is useful for women at intermediate risk of developing breast cancer, including those who have undergone breast biopsies.
Phenogen Sciences has now hired its initial sales team in preparation for the imminent launch of BREVAGen.
Phenogen Sciences president and GM Lewis Stuart said 64% of the target patient population have their breast cancer risk re-classified as a result of using the BREVAGen test, providing a personalized and actionable assessment.
"Many women will have their peace of mind improved by being re-classified to a lower risk group while for others, they will be re-classified to a higher risk group, enabling decisions regarding increased surveillance or even cancer preventive therapy," Stuart said.