Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) will expand sales of its BREVAGen™ test into the Florida market after the grant of a permit that clears the breast cancer risk assessment test for sales in the U.S. state.
The permit was granted to the company’s Australia-based laboratory by the Clinical Laboratory Unit of the Florida Agency for Healthcare Administration, and follows the earlier clearance of BREVAGen™ for sale in California.
Combined, Florida and California represent between 15% and 20% of breast cancer incidence in the United States.
Genetic Technologies expects to immediately start securing BREVAGen™ sales in this key territory, having already pre-qualified several key accounts.
BREVAGen™ is a novel genetic test panel that examines a patient's DNA to detect the absence or presence of certain common genetic variations 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, plus factors from a standard clinical assessment based on a patient's family and personal history, therefore giving a clearer picture of an individual woman's risk of developing breast cancer.
U.S. State Certification
In April 2011, Genetic Technologies successfully attained CLIA approval, allowing BREVAGen™ to be sold into 42 U.S. states.
Following the receipt of a certificate of compliance issued by the Centers for Medicare and Medicaid Services, the company has submitted numerous applications for “Out of State Licensure,” which allows BREVAGen™ to also be sold in Pennsylvania, Rhode Island, Nevada, Tennessee, Maryland, California and now in Florida.
Genetic Technologies has also submitted a an application along with supporting test documentation to the New York State Department of Health, Clinical Laboratory Evaluation Program (CLEP) to offer out of state clinical lab services to New York State residents.
Once New York State approval is granted, the BREVAGen™ test will have been cleared for sale in all 50 U.S. States.
U.S. breast cancer market – compelling opportunity
The U.S. breast cancer market is around US$600 million and growing, with the incidence of breast cancer to increase by 20% by 2020.
BREVAGen™ is the first clinically validated predictive sporadic breast cancer risk assessment test.
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