The certification is the culmination of preparations required for the US launch of the BREVAGen breast cancer test, which informs clinicians about their patients’ individual, non-familial, sporadic risk of breast cancer.
The BREVAGen breast cancer risk stratification test is a novel 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 test is designed to help physicians assess 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.
The BREVAGen test may be especially useful for women at intermediate risk of developing breast cancer, including those who have undergone breast biopsies.
The test will provide information that can help physicians recommend alternative courses of action, such as more vigilant, targeted surveillance or preventive therapy, on a personalized patient-by-patient basis.
Genetic Technologies CEO Paul MacLeman said BREVAGen is the first in a series of products in the company’s anticipated expansion of its oncology and cancer management test portfolio and the company is all set for commercial roll out.
CLIA certification will enable Genetic Technologies’ Australian laboratory to offer compliant high-complexity medical testing services to US patients via its wholly owned US subsidiary Phenogen Sciences.
Under the CLIA certification, GTG may also add further cancer management products in development to its test menu without need for further regulatory applications.
BREVAGen will be made available to European and PacRim markets following further regulatory and market development programs.
